It's Been Another 6 Months

I can't believe it's already been 6 months since Abigail's last appointment for the Peanut Sublingual Immunotherapy Clinical Trial. It was time for another trip to Durham, NC, and the Duke University Hospital. This particular visit marks our two year anniversary in the program. Just 365 more days of daily drops, one more 6 month blood work appointment, two more food challenges and we're done. Unofficially anyway. There will still be follow-up visits to monitor her desensitization.

Another visit down!

You can tell from this picture that Abigail is just thrilled to be back. Upon our arrival, we were just a little confused. "Clinical Trial Research Unit" was no longer labeled on the front doors. At first we wondered, if in the last six months, they had moved the unit to a different part of the hospital. This small sign was all there was to announce that yes we were still in the right spot. They now share this hall with another cancer unit and it got top billing on the big double entrance doors.

This visit, like the rest, started with weight/height measurements and the application of numbing cream on both her arms. She then had to spit in a tube (her least favorite part of the visit) and sit through a skin prick test.  This test is no longer as uncomfortable as it used to be.  The skin reactions are now minimal, and her back doesn't itch near as much.

Abigail's doctor marking where the skin will be pricked.

Final results.  Some swelling at highest dosage (on top left).
Minimal swelling at the remaining pricks.

Here is a link to pictures of Abigail's last two skin prick tests.  There have been visable changes each time.  She also had 6 vials of blood drawn and then it was time to say good-bye to Dr. Kim.  His Fellowship at Duke is over, and he has accepted a permanent job in Chapel Hill.  We'll miss seeing him on our visits.  He was fabulous with Abigail and extremely patient in answering all of my many questions.  There is already another doctor assigned to continue Phase I of the Peanut Immunotherapy Sublingual Trial.  We did not get to meet her at our appointment.  While we were having our visit, she was busy doing a food challenge with the very first patient in Phase II of this trial.  I'll follow up on details of that trial in a different post.

So, what's next?  Daily drops, a report on Abigail's IgE results from this visit and a 6 month lab appointment in January 2012.  Starting in December of this year, the first participants in our trial will be starting their end of study food challenges.  When we go back to Duke in January, we'll be updated on those results.  Then in June, Abigail will have her food challenge.  If she can tolerate it, she'll be given the equivalent of 20 peanuts.  Assuming there are no issues, and I'm not expecting any (she tolerated the full 10 peanuts at her food trial last year), we'll be asked to not give her the drops or any peanut product.  After 6 weeks, she'll be given a food challenge again to see if she can continue to tolerate the 20 peanuts.  If so, we'll then introduce small amounts of peanut into her diet and/or continue the drops.  That's yet to be determined.  And, just as important, if she tests negative again to tree nuts, I'll be able to again purchase products manufactured in facilities using tree nuts.  Even better, her doctor felt she'd be able to pick up a can of any type of tree nuts and just munch.

While a year seems so far away for Abigail, I look back at how quickly the last 2 years have flown by, and how much progress she's made.  I'm looking forward to the conclusion of the study.  What will I blog about then?

Single Digit IgE Number

In the craziness of moving, preparing for Easter and our trip to the beach (where I'm writing this post), I almost forgot to tell everyone about my latest call with Abigail's doctor at Duke.  Now that Abigail is on the maintenance dose, we only have to drive to the Duke Clinical Trial Unit every 6 months for lab work.  In between those visits, the doctor calls to check in to see how she is doing, and to see if there are any issues or concerns.  I had not heard her IgE lab results from our January trip to Durham so I was anxious to find out what her new numbers were.

Her IgE number is in the single digits!  That's incredible!  Our goal is to get her number to 2 by the end of the study.  We are on our way.  Her number is now 9.28.  With a year still to get there, I quote our doctor, "Abigail has a really good chance of kicking this thing."

Her IgE numbers are following the pattern that they are seeing with the other clinical trial participants.  When Abigail was 18 months old, her number was in the 14 range.  When she entered the study at age 7, her number was 10.4.  During the study, it spiked to 16.7, then down some to 15.5, then 12.9 and a year and a half into the study she's at 9.28.  One of the biggest conclusions the staff at Duke has made is that this process takes time.  They increased the sublingual immunotherapy study length by 6 months for a total of 36 months instead of the original 30.  They've found that the extra time is getting the numbers that they want to see.

While Abigail's IgE numbers were in the teens to start, Duke is still seeing the same trend with children that start with numbers in the 300's, 800's and even 1000's.  The number curve is still the same.  The numbers spike and then drop along the same curve.  I have a friend whose daughter's IgE number was in the 300 range, spiked up over 500, but is now in the 50 range.  It sounds like a long way to go to get to 2, but her percentage change is in line with Abigail's.  Her daughter is just seeing the drastic changes while Abigail's change of 2 to 2 1/2 points is equally a big deal.

Bottom line...it's working!  We are so blessed.  You guys hang in there too.  The latest trial that Duke is doing now is administering the peanut protein via a patch.  I really believe doctors are doing everything they can to make this process of desensitization as easy as possible to administer so that it can be done by allergist and doctors beyond those involved in the trials.

High School Freshman in Coma

A 14 year old, high school freshman girl is in a coma after going into anaphylactic shock. The coma is a result of delayed CPR and an extended period of time without oxygen flowing to her brain. There are plans later this week for her to undergo surgery so that a feeding tube can be inserted.

Apparently, she was hanging out with some friends after school and they were eating Kellogg's Crunchy Nut cereal for a snack. The words "peanut" or "nutty" appear about 20 times on the cereal box. She did know the severity of her allergy. There is no mention of an epinephrine pen anywhere in the article. Her dad mentions that Benadryl had worked on past minor allergic episodes to MSG and preservatives.  Here's the link if you'd like to read the full story and see the Fox News video clip interviewing the girls father.

I really don't know how to comment. It's a very tragic tale that brings up more questions than answers.  I can say this though.  It's a perfect example of one of the main reasons that my husband and I decided to pursue the peanut clinical trial at Duke, and why we're putting Abigail as well as our family through repeated 290 mile round trips to the Duke Clinical Research Unit, multiple blood and skin tests and a daily regiment of drops for 3 years.  We were very concerned of what would happen when our very strong-willed, opinionated daughter reached the pre-teen and teenage years and was no longer under the constant supervision of either ourselves or another adult.  My husband agrees.  Ironically, when I told him about this girl in Phoenix and the tragedy, his first comment was, "that's why we are in the clinical trial."  What a blessing this trial is for our family, and we pray that the results bless many in return.

A mom wrote on a food allergy message board that she trains all of her teenage daughter's close friends on the signs of an allergic reaction and the administration of an EpiPen.  Prior to letting her daughter go anywhere with her friends, she makes sure that they are all aware of where the EpiPen is and asks that they make sure it doesn't get left behind in the car.  What a great tip.

In the meantime, we need to keep this young girl and her family in our prayers.  I can't imagine what they must be going through or how much they are suffering.

Latest Trip to Duke

It's been three months since our last trip to Duke University Hospital.  It was time to hit the road and make the drive to Durham to visit the Duke Clinical Research Unit.

It was a lab visit.  These occur every 6 months.  I think Abigail dreads the saliva collection more than the blood draw.  She dislikes spitting into that collection tube.  She also had another skin prick test.  The last one was done at Abigail's food challenge back in June of last year.  Here's a picture from that test.

 

Here's a picture of her back after the test this week.  The top prick on the left is the highest dose of the peanut protein.  The prick on the bottom right is the histamine.  That first prick is about the same size as the one in June 2010.  The second prick was about the size of a pin head.  Her doctor traced it, but didn't record the others.  There was nothing to trace.  You can definitely see the difference between these tests.  How exciting! 

Last, but not least, they had to do a blood draw to get new IgE numbers.  I know they do a regular blood panel to monitor her overall health, but I'm not sure what else they look at.  Regardless, there were 5, maybe 6 tubes they needed to fill.  Do you know what Abigail did?  The nurse inserted the needle, but Abigail put on and removed each of the tubes.  It was unbelievable.  Here's a picture of her changing out the tube.

Six months ago, Abigail's IgE number was 12.8.  The doctor thinks that this time around we might possibly see a single digit number on the lab report.  I can't wait to get those results!

There was also opportunity to ask lots of questions about what's next for us in the trial as well as get an update on the results to date of the sublingual immunotherapy study. I'll cover all of that in my next post.

A New Year's Thank You!

I hope everyone has enjoyed these last days of December and the many holiday events that fill the calendar this time of year.  I also hope that everyone has stayed safe and healthy.  Is it too much to also hope that everyone spent the holidays stress free and not in the least bit worried about the safety of their peanut allergic child?

I must admit that due to our participation in the peanut clinical trial at Duke, my worries have been a lot less than in previous years.  Knowing that Abigail is on the actual peanut protein drops and that she flew through the food challenge like a champ alleviates a great deal of the worry.  I was still diligent in checking ingredients, I still packed a few safe party food alternatives for those family gatherings, I still volunteered for her class Christmas party and even made sure I was the one signed up to bring the sugar cookies to decorate and I still had to comfort the disappointment when a few really scrumptious looking desserts had to be passed up on because of ingredients that might be subject to cross-contamination.  But, the worry of who was eating what where wasn't always in the back of my mind, and there were no hurt feelings when a hostess hadn't taken her allergy into consideration.

So, here on the last day of the year 2010, I wanted to take a minute and thank everyone at the Duke Clinical Research Unit that have made it possible for us to be on this journey.  Our family is so very grateful for this opportunity.  I also wanted to thank our family and friends that have supported us with many prayers, hours of childcare for our 3 year old and their overall interest in Abigail's progress.  Lastly, I wanted to thank you, my wonderful readers, that have been so generous in your comments, well wishes, blessings and e-mails.  I can't possibly explain how much this blog and your interest means to me.

Many Blessings for a Safe and Happy 2011,
Melanie
a.k.a. Mom with a Mission

Interview with Dr. Wesley Burks

In all of our trips to the Duke Clinical Research Unit, we've never actually met or even seen Dr. Wesley Burks (Chief of the Division of Pediatric Allergy and Immunology at Duke University Medical Center in Durham, NC). This picture is as close as we've come. I've joked before that I feel like if we do, we should ask for his autograph given the amount of publicity he and his department get regarding their research of food allergies.  All joking aside, we are very grateful to Dr Burks and his staff at Duke for allowing Abigail the opportunity to participate in the peanut sublingual immunotherapy trial, and for giving her the chance to become peanut allergy free!

A fellow mom/blogger of food allergic children recently had the opportunity to interview Dr. Burks.  She has an informative website, www.allergymoms.com and a blog at http://www.allergymoms.com/modules/wordpress/index.php.  Here is the link to her interview with Dr. Burks.  It gives a great overview of the immunotherapy clinical trials, some results they've seen, next steps, etc.  There's more information on the oral immunotherapy trials (peanut flour) than the sublingual (drops that Abigail takes) because that was the original trial, and they have 5 plus years of data.  Our doctor for the sublinugal trial has submitted a paper and hopes that it will be published soon.  We're looking forward to reading about the current successes of the sublingual study.  It's neat to know that Abigail's data is a part of those results.

Another trip to Duke by way of the beach!

It's been over 3 months since we've last been to the Duke Clinical Research Unit for the peanut SLIT trial.  In fact, our last visit was the food challenge when Abigail consumed up to 8 to 10 peanuts.  Since then it's been status quo.  She continues to consume nothing with peanuts, nothing made using the same equipment or nothing even manufactured in the same facility with other peanut products.  She still takes 8 drops once a day under her tongue, holds them there for 2 minutes and eats nothing before or after for the specified time period.

This visit was short and served only as a "check in" to answer questions and get more drops.  Our next visit, 3 months from now, will be a little more involved.  There will be another blood draw, skin prick test and saliva collection.  This routine will continue until May of 2012.  Every 6 months, testing, 3 months in between, a "check in", maybe even by phone to save us a 2 1/2 hour drive.

I did hear a few updates at this visit.  Our doctor and staff have written a paper with the findings to date.  It's in edit now and should be published by the end of the year.  It's pretty exciting that we've been in the study for long enough that initial results are ready to be made public.  Also, that we are part of those results.

There is also not going to be a food challenge at the 2 year mark as originally planned.  The protocol indicated that a challenge to up to 15 peanuts would be given.  I think they've determined that the food challenge process does not warrant knowing if a child can consume 5 to 7 more peanuts.  If some of the participants in the study can eat 8 to 10 peanuts then they've proven that you can be "desensitized".  Staying on the drops for 3 years is a means to become "tolerant".  Abigail will be food challenged again at that 3 year mark.

I've mentioned in a prior post that the immune system is slow to change, and in the case of food allergies, can take 3 years or more of daily dosing to build up tolerance.  The peanut flour trial has been going strong for over 3 years.  Participants are now eating peanuts on a daily basis, but what happens when they stop eating peanuts.  Will their body remain tolerant?  That question is still unanswered.  Some of those participants stopped for as long as 3 months and were able to then pass the food challenge again.  But Duke has not had them remove peanuts from their diet for any longer than that?  I definitely didn't sign us up for that study!

We incorporated a long weekend at the beach in with this visit.  It was much needed and well deserved.  We finally got our house officially on the market, but it's been an exhausting process.  A trip to the beach was just what we needed.  The weather was fabulous, and we did nothing but play and rest.  There were tidal pools out in front of the house every day that the kids loved swimming in (yes, swimming in October).  Abigail was a real pro at building sand castles as seen in the picture.  So, another trip to Duke, but only after a great weekend at the beach!

Not all Sunshine & Roses

There can be a darker side to participating in a peanut clinical trial as a mom in our community recently discovered.  We had a "sunshine and roses" food challenge experience, i.e., it was all good.  Her and her son....not so much. With her permission, I thought it important that you hear her story.  And, don't worry, it's not all doom and gloom.

They had a rough go of it right from the start.  Her son was one of the original and unlucky participants in the SLIT trial at Duke that was impacted by a lab snafu and had to re-start the trial.  This was after having already driven back and forth for months.  She lives a couple of towns over from me, and it's a long drive.  I can attest to how horrible it would have been if Abigail had to start over.  In her son's case he had been on the placebo drops and would have had to begin again anyway.  In my opinion, I think that's somewhat a blessing.  I think it would have been even harder to bear if a child had been on the peanut protein and still had to start over.  Fortunately, these children were guaranteed that they would receive the peanut protein drops when they re-entered the study.  Needing a break, they didn't immediately re-enter and ended up starting back after us.  So, with Abigail's food challenge success fresh in her mind, they showed up for their 8 a.m. appointment.

He received the placebo during the morning challenge.  During the peanut flour challenge that afternoon, all was going well, and he was showing no clinical signs (rash, hives, runny nose, stomach pains, vomiting, etc.) of a reaction.  By the next to the last dose though his mom's gut instinct was kicking in, and she was ready to call it quits.  It was that final dose that did it, and her son went into full anaphylaxis.  From her account, our doctor and nurses handled the situation fabulously.  They gave him Benadryl, and were ready to wait to see if that was enough.  Seeing her child the reddest of reds, covered with baby hives and having difficulty breathing, she insisted that they give him an epinephrine injection.

Having made it through all the doses, I can just imagine the shock of seeing the worst of reactions with no signs leading up to that point.  Our doctor recorded that he was able to tolerate 8 of the 9 doses.  Her question though, and a very valid one, is what if it was a delayed reaction?  What if given more time between dose increases, he would have had a reaction at a smaller dosage?  Without another food challenge, it's probably impossible to say. And, given her experience, she confirmed that that wasn't going to happen again anytime soon.

Now, for the positive.  Bottom line, he was able to consume peanuts, and with a starting IgE number of over 200 that's significant.  He probably could even consume enough to eliminate considerable worry about the possibility of cross-contamination.  And, more importantly, her son is no worse for the wear!  He still takes his drops without worry.  Can't say the same for mom.  She's a little traumatized over the whole experience and says knowing that after consuming an unknown amount of peanuts, he can go from 0 to 100 without any type of warning had her doubling the amount of Epi Pens they kept on hand.  She also feels guilt over having put him in that situation to begin with.

They're sticking with the study. Like us, I think they feel blessed that they do have the opportunity to participate.  I know so many of you readers pray for that time when either the end results of these clinical trials are available for you or your children or such time when a clinical trial comes to a location nearby.  We do this with the full realization that we're providing our children a different path down life's very difficult journey.  Having had to experience an anaphylactic reaction really stinks, and it's not something even our doctors want to have happen.  But, in her case, it was part of providing that different path...that path to becoming peanut allergy free!

Still in disbelief!

I'm getting lots of e-mails, Facebook postings, blog comments and excited greetings.  I can't thank you guys enough for your support.  Truth be told though, I'm still very much in disbelief and not quite sure how to express my feelings about the success of the food challenge.

Realistically, nothing changes. Abigail still takes her 8 drops a day, holds them under her tongue for 2 minutes and can't eat 15 minutes prior or 30 minutes after. She'll continue to do this daily for at least another 18 months until the end of her treatment.  We're to make absolutely no changes to our eating habits which means I'm still reading every label and our family will continue to avoid unsafe restaurants.  Abigail will still bring her own cake to birthday parties, we'll still ask friends and family to not have peanut products sitting out when we visit and I'll still meet with her next year's teachers and classmates and put the same protection policies in place at school. We're to always have her Epi Pen and Benadryl handy.  In other words, we continue to live day to day under the assumption that there's always a chance for accidental exposure.

I know that at some point her passing the food challenge with flying colors will set in.  I think that at some future time, even if I can't relax regarding what she eats, maybe I'll relax when it comes to social settings. Those situations that I currently give my o'kay, but worry about.  For example, lunch time in the cafeteria at school.  I worried about her sitting in the same spot that someone eating a peanut butter sandwich just vacated.  I worried at family functions when there was a safe dessert tray and an unsafe dessert tray.  I worried about friend's birthday parties, sleep-overs, church events and camp.  And, that list goes on and on.  You can't do that much worrying for 7 years and have it go away over-night.

It's really an emotional roll-coaster.  I'm sure it's confusing to Abigail as well.  She ate the equivalent of almost 10 peanuts.  Her doctor is smiling from ear-to-ear, she's getting hugs and treats, told how brave she is and then, by the way....you still can't eat anything with peanuts.

So, with some reserve, we're celebrating in the short term, but we're also still looking forward to the long-term.  There's quite a journey ahead with lots of unanswered questions.  Maybe a few more days of congratulations, and then I think we have to file this experience away until such time when we can truly celebrate.  I really think the best part of our food challenge experience is to know with confidence that we are getting the real stuff and not the placebo, that the SLIT methodolgy is working, that our time is not wasted and that we made the right decision to put Abigail through all of this.

Thanks again everyone for your support.  I attached a few pictures from our day at Duke.

It's 8:00 a.m. and Abigail is ready, although somewhat nervously, for her big day at Duke.











I've included these pictures so you can see the difference in her skin prick test between this week (1st picture) and her skin test in January.

I.V. is in and we're ready to start the food challenge.

Of course there were lots of treats.  Here we are enjoying a new DS game together.

This is it.  Last dose of the day.  She doesn't look any worse for wear does she?

Food Challenge Time

It's finally time. We've been participants in a Peanut Sublingual Immunotherapy Clinical Trial for over a year. May 18th marked our one year anniversary and June 23rd marks our first food challenge. Come 8:00 Wednesday morning, Abigail and I will be at the Duke Clinical Research Unit nervously and anxiously waiting to begin.

I've been quite excited waiting for this day to come.  Abigail has been more on the nervous side.  I've given her all the details I think she can handle.  I've clarified that they are not going to take her to the point of her having an anaphylaxic reaction, and it was evident that she was relieved.  Now, the day before, I'm getting a little anxious as well.  I just so badly want to see good results!

Here's what our day looks like. We start right off with testing.  Abigail will have to immediately get an I.V., then have blood drawn, have a skin prick test and spit in a tube for a saliva test.  Around 9:00 a.m. we'll start the 1st of 2 food challenges.  It's a blinded challenge so one will be peanut flour and the other oat flour.  The staff in the kitchen actually makes the call as to what comes first.  We're not supposed to know until after both challenges, but I hear it's pretty hard to not smell the peanut flour.  The flour will be mixed with applesauce.  I'm also bringing chocolate pudding, cinnamon applesauce and because she occasionally eats sunflower butter, I'm bringing sunflower butter and crackers to give her some variety.

There should be no issues with the first couple of doses.  If I'm reading my notes from our last Duke visit correctly, by the 4th dose, she'll be getting 100 milligrams, 5th dose, 250 milligrams, etc.  The 9th dose is the equivalent of 8 to 10 peanuts, over 1500 milligrams.  If she can tolerate it, they'll stop the challenge at the 9th dose.  There's a 2 hour break, and then the process is repeated with the second challenge.  It's going to be a long day.  We're expected to wrap up between 5 and 6 o'clock.

They'll be monitoring her the entire time.  Benadryl and Epi Pens will be right there, and of course, she'll have the I.V.  Every few minutes they'll check for a reaction.  Our doctor and a nurse will be there, with another nurse stopping in periodically with a new set of eyes.  We're looking for sinus issues, hives, stomach pains with possible vomiting.  Any of those symptoms will stop the challenge.  Her history of stomach aches adds a little complexity.  Her stomach hurts when she's nervous so we'll have to push through that.  That's also why they do a blinded challenge with both peanut and oat flour so they can rule out a psychological reaction.  According to her doctor, the biggest sign of a reaction is a change in behavior.  He says that the kids will be playing their Nintendo DS, watching a movie, reading a book, etc., and then all of a sudden, they stop and go lay down, kinda withdraw.  Small children will crawl in their mom's lap.

We're taking lots of movies, and I've got my bag of treats packed.  It's a big day for Abigail.  The good news is that they're seeing a clear difference in the study results between the children getting the peanut protein and the children getting the placebo.  At the end of the day, Abigail's file will be unlocked and we'll see what she's getting.  I'm 99% sure that we are getting the real thing, and I'll be embarrassed if we find out that she's been on a placebo all this time.  I really don't think so though.

According to our doctor, based on the 40 plus food challenges already completed, they know that the sublingual immunotherapy works, the question now is how to make it work better.  Keep us in your prayers on Wednesday that it works for us.  I'll post an update Wednesday night.

Yesterday's Visit to Duke

It’s spring break for the kids and we’re spending a couple of days at the beach.  On our way here we stopped by the Duke Clinical Research Unit for our final appointment before our food challenge scheduled for early June.  It was a short appointment consisting of a quick vital check for Abigail, getting a new bottle of drops, discussing the details of the challenge, and most importantly, talking about Abigail’s stomach issues.

I feel good about the food challenge.  I really think that Abigail is getting the real stuff and not the placebo.  I’m going to feel incredible foolish if she’s not.  Her symptoms/complaints after receiving each dose increase are classic side effects of sublingual immunotherapy (SLIT).  I just recently learned this when I started researching the side effects in hopes of finding an answer to her belly issues.

A study by the American Academy of Otolaryngology – Head & Neck Surgery Foundation explored data from selected clinical studies and concluded that “sublingual immunotherapy may be well suited to fill the gap posed by the undertreatment of allergic syndromes in the U.S.”  I’ll touch on some of the details of this study in another post but the biggest take-away for me was that they found that the majority of adverse effects are minor and include mostly itching and oral discomfort.  In one study with 36 children only 2 children experienced adverse effects, Surprisingly for me, it was mild abdominal pain.  In a study with 354 children minor adverse affects occurred in less than 10% of patients.  Oral/throat itching, abdominal pain, urticaria and rhinoconjunctivitis all occurred in less than 1%.  No anaphylactic or other serious reactions occurred.  Similar findings were noted in 9 other trials. So, there is a possibility that Abigail’s stomach could be a result of our participation in the study.  After all, she also experiences the tingling in her mouth, throat and ears.

A side note to parents with kids in the study.  Please don’t assume your child is on the placebo if they’re not experiencing anything.  There’s a 50/50 chance that they aren’t.  My daughter is the exception here not the norm.

Here’s what we’re going to do about Abigail’s stomach.  Her dad and I decided to start her back on Prilosec.  We have to rule out acid reflux.  Also, more disturbingly is Eosinophilic Esophagitis (EE).  There have been 2 instances where children have left the study because they were diagnosed with EE.   In talking with our doctor at Duke they don’t know if taking part in the study was a direct cause or if it just unlocked a dormant condition.  However, until they know more, it’s now something that they discuss with patients at the start of the study.  Like food allergies, EE is a condition with more unknowns than knowns.  In both cases, the child was removed from the study, given oral steroids and symptoms subsided.  It’s a huge concern for me.

If Prilosec works, we can rule out EE and avoid an endoscopy.  It might take up to 8 weeks to see if it will work which puts us right about the time we have our food challenge.  If it doesn’t work, and we unveil to find she’s on the placebo, we have to start looking at other culprits.  If it doesn’t work, and we find that Abigail is on the peanut drops, we’ll have some hard decisions to make.  After the food challenge, there’s still 18 months left in the trial.  I asked our doctor if it was possible that when she builds up complete tolerance to her food allergy her stomach pains will go away.  It’s possible.  I also asked if her stomach could take weeks, even months, to heal after continuous exposure, and found that might also be the case.  There’s just no way of knowing.

So, for now, it’s Prilosec which is not without risks.  Prilosec reduces the levels of acid in the stomach making it easier for bacteria, viruses and fungi to flourish.  Low acid also prevents nutrients from properly assimilating through the body causing nutrient deficiencies.  The article, “Why You Should Never Take Prilosec OTC to Remain Heartburn Free,” identifies the main cause of excess acid is eating foods that your body is intolerant to or allergic to.  We know Abigail’s being exposed to peanuts (or at least very sure she is), and it’s not as easy as just eliminating that food.

One last thing we’re doing is giving Abigail her drops in the morning rather than before dinner.  Her stomach hurts most around bedtime which is about 2 to 3 hours after getting the drops.  Maybe we’ll see a difference if we don’t add something that has the potential to hurt her stomach around the same time she eats the heaviest meal of the day.

All this, and I never got to discuss the food challenge details.  I’ll have to save that for another day.

14th Visit to Duke

We went to the Duke Clinical Research Unit yesterday.  It was our 14th trip, and our first visit of 2010.  We're in the maintenance phase so the purpose of our visit was not to get a dosage increase, but for our 3rd round of testing.  It was a short visit, but a full one. Abigail had a skin prick test, about 7 vials of blood drawn and a saliva sample taken.  All that warranted 3 escalator rides, 1 for each test, when we were done!

Let me start by saying that Abigail did absolutely fabulous!!  Not one complaint!  I did think it was cute when Abigail asked the nurse if she would only stick her once (last time it took 2 tries).  She also watched and even helped change out the vials.  I was very impressed and very proud.  I should also thank the nurses.  They're pros and their no nonsense approach really helps.

Abigail's skin prick test results were much worse than the time before.  I do remember being told to expect the results to get worse before they get better so I'm not sure why the results of her 2nd prick test were much better than the 1st or the 3rd.  I also had the opportunity to talk with our doctor about the food challenges.  They've done 10 so far.  He couldn't share specific results with me, but he did say that they were feeling good about what they were seeing.  He also told me that based on what they were seeing, there was no plan to make any modifications to the study protocol.

There were a couple of other eventful happenings at this visit.  I was able to meet another mom that I've been communicating with for several weeks.  Her daughter was at Duke for her very first visit.  She and I have been e-mailing back and forth discussing all aspects of the trial.  She's had lots of questions, and I was able to give her a good amount of information.  I'm hoping our discussions have been helpful as her family starts the journey to becoming peanut allergy free!

Another really cool part of our visit to Duke was that my mom came with us.  Abigail and I loved having her spend the morning with us.  After our appointment, we took Abigail to a birthday lunch at CiCi's Pizza and surprised her by having both my dad and sister meet us there.  By the way, none of CiCi's products contain peanuts, are made with peanut oil or processed in a plant with peanuts.

All in all, it was a great trip.  We don't have another appointment scheduled until the first of April when we go to discuss the details of our food challenge in May.  We've got a long way to go yet, but I'm overcome with how blessed we are to be a part of this trial.

Duke Clinical Trial Update

I haven't written about our visits to Duke in a while simply because we haven't gone in a while.  Our last visit was the first week of December, and we don't go back until the second week in February.  Abigail is on the maintenance dose which means we no longer have to go every other week to increase her dose.  We go back in February for blood work, in April to discuss her pending food challenge and the end of May for her food challenge.

Speaking of food challenges, they've started for this study.  The first food challenge occurs 12 months after entering the study.  It's double blinded so that each child will get both a round of peanut flour and oat flour. They do that because nausea and vomiting can be a side effect of both a peanut reaction and pure anxiety. When I talked with our doctor late last week, 6 children had already completed their food challenge, and another 2 were schedule for each week over the course of the next couple of months. 

The first 3 kids to do their food challenge ended up being on the placebo, and will have to re-enter the study.  They're guaranteed to get the peanut protein this time around. There were mixed results on the other 3 that were getting the peanut protein. They didn't see particularly good results on the first two children, and it sounded like there were some extenuating circumstances for both.  However, the third child tolerated the full dose of peanut flour. Did I mention that it was the equivalent of 8 1/2 peanuts??  I know it's just one child, but I couldn't help getting very excited when I heard the news. Only time will tell, but it is very encouraging and makes our food challenge something to look forward to as opposed to dreading!

It's believed that just a small amount of daily peanut protein, over time, will re-train the immune system to accept the offending allergen as normal.  What Abigail's doctor explained was that the immune system is very slow to respond.  A year may not be long enough to re-train the immune system.  So, the results of the first food challenge aren't necessary indicative of the final outcome.  Between me and you though, I'll take 8 1/2 peanuts all day long!!

Healthy Change #6: Avoid Chemicals in Foods

When I started this journey to share our experience in a Peanut Clinical Trial at the Duke Clinical Research Unit, I didn't realize that it was going to lead me down the path to also sharing what I'm learning about the food we eat.  I feel though that it all ties together. We're at Duke because Abigail has a peanut allergy.  I'm now reading labels and questioning ingredients because Abigail has a food allergy.  I also believe that the food we are eating and the environment that we now live in is a major contributor to the rise in food allergies.

Having to read the label of every single item that I purchase and spending hours reading about the latest news and trends in my search to better understand peanut allergies has opened my eyes to a myriad of nastiness in the food that I was serving my family.  I feel like I might have been able to prevent Abigail's peanut allergy had I known then what I know now, but I try not to beat myself up about it. I was in a different time and place back in 2003.  What I can do in 2010 and the years following just by modifying our diet is try to prevent cancer, high blood pressure, heart disease, diabetes, depression and other illnesses, attention deficit in my kids (and myself), asthma and other allergies.  That I have control over.  So, in addition to avoiding rGBH, conventional meat and produce, GMO products and farm-raised fish (both still to be discussed) we also try to avoid trans fats, high fructose corn syrup, partially hydrogenated oils, sodium nitrate, artificial sweeteners and artificial food dyes.

It's the weekend, and I'm not going to go through a long list of the pros and cons of different ingredients.  I will though, provide you with a great tool to use when you look at a label and don't have any idea what the ingredient is, much less how to pronounce it.  It's an alphabetical listing of all of the chemicals that food manufacturers add to processed foods.  It's got a great guide that indicates whether the chemical is safe, if you should cut back, if you should try to avoid the food and lastly if you should avoid the food at all costs.  It's not light reading.  I admit, I've not printed it out, studied it in great detail or anything like that.  I did note the chemicals that we should avoid at all cost and 9 times out of 10 will put a product back on the grocery shelf if I see one of those in the ingredient list.

Here's the link:  Center for Science in the Public Interest, Chemical Cuisine.  I'd wish you happy reading, but it's neither light or entertaining!  It is, however, an eye-opener!

Too Much Rain

We were scheduled to go to Duke yesterday for Abigail's final dose increase before hitting the maintenance stage of the trial.  After hearing the forecast, I decided to postpone our appointment until next week.  I know that sounds crazy, but the weather forecast called for heavy rain here, there and all the way in between.  It seems like every other visit to Duke I'm driving in heavy downpours, and it is miserable.  Besides, the kids are staying with my parents this weekend and will already be three quarters of the way to Duke.  Made more sense to swing by and pick up Abigail Monday morning and head to Durham as opposed to going Wednesday and then driving both Saturday to drop them off and Sunday to pick them up.  Unfortunately, Abigail will miss a day of school, but then again, she is only in the 1st grade.

So we'll go on Monday, and then not again until the end of January.  That visit is only scheduled to take 45 minutes but will be a lab visit meaning a blood draw, skin prick test and saliva collection.  Given our tract record, that visit might actually take more than 45 minutes.  After that, we don't go back until mid April when we'll discuss the logistics of the food challenge which will be the end of May.  In the meantime, I'll be checking in to find out the results of all of the food challenges prior to Abigail's.

I've attached a link to an ABC News segment.  It features Dr. Burks discussing the clinical trial research.  What's neat about the segment is that you can see where we go every visit, how the drops are administered and even see some of our great nurses.  Here's the link:

Children's Food Allergies Escalate

I'm working on my first ever product give-away.  I'm quite excited about it.  Hopefully by next week I'll have all of the details worked out.  So, visit again soon.

A Lot to be Thankful for....

In the hustle and bustle of everyday life, I often lose site of how very much I have to be thankful for.  It's been another one of those days.  Laundry, baking for Thanksgiving, cleaning house, packing for a weekend trip, worrying about a sick child, running errands, and now, absolute exhaustion.  Even now, I'm multi-tasking.  I have a "to do" list beside me, I'm trying to catch up on a few shows, and obviously, I'm writing this post.  How does a mom learn to just simply enjoy, to count her blessings?  At least this mom!

Regardless of the chaos, I do have an incredible amount to be grateful for.  In this time of economic turmoil, we've got a handle on our finances.  My family is healthy minus a couple of bouts with H1N1, some sinus infections and a case of bronchitis (my 2 year old has that now).  I'm married to an incredibly supportive man who puts up with all of my tangents and soap boxes. My kids are sweet, smart and well-behaved, at least with everyone else.  And now, this year, our family has this peanut allergy clinical trial.

We are blessed with an opportunity to change Abigail's life, and I'm very much aware of the fact that there are parents all over the country that would love to have the same opportunity for their child.  Abigail could come away from this trial with the ability to consume peanuts without the risk of a life-threatening allergic reaction.  Whether it's the ability to consume a handful of peanuts or just eat a baked item manufactured in a plant with another peanut product, her life is still changed.  And for that, I am extremely grateful.

So, thank you to our great doctors and nurses at the Duke Clinical Research Unit, to our parents who have provided many hours of childcare to our youngest as well as hours of listening to me discuss the trial, our concerns and our progress, and to you guys who give me an outlet to share all my research.

Hope everyone has a great Thanksgiving.  Enjoy your day, travel safe and count your blessings!

IgE Numbers, Part 2

At our visit to Duke this week, I was able to spend some time talking with one of the wonderful nurse practitioners about the upcoming food challenges.  Several of the Peanut Sublingual Immunotherapy participants are quickly approaching the 12 month mark and the first challenges are scheduled for December 10th and the 14th.  I mentioned how I was anxiously awaiting the results, and she very quickly reeled me back in. With this being the first peanut sublingual study for children, there are a lot of unknowns.  It's very possible that the first food challenge won't show significant results and may even mean a change to the study protocol.  I'll still call soon after the challenges to find out the results, and hopefully, the kids consume the equivalent of a peanut or two.  If they don't, then we'll keep pushing through, Abigail will keep taking her drops and we'll hope that with more time we'll all see the results we are hoping for.

I'd love to be able to see Abigail's IgE numbers over the course of the study, but they are sealed until the end.  The goal is to get her number down from 14 to a single digit.  At a single digit, her chance of having a allergic reaction drops significantly, as well as the risk of anaphylaxis.  She'd still be allergic to peanuts, but her allergy would not be life threatening.  Abigail would be considered "cured" of her peanut allergy if her number was a 1 or less.  She's had two blood draws to determine her IgE number since starting the study.  The first was the baseline (which was 14), and then again at 4 months.  Her next blood draw is at the 8 month mark.  We can't see the numbers so that we don't get discouraged if they're not changing.

IgE numbers only tell the percentage chance of having an allergic reaction, they do not tell the type of reaction or severity.  Whether the IgE number is 14 or 364, there is still a 95% chance of having a reaction.  I'm going from memory (which is often a risky proposition), but I seem to recall that when Abigail was tested at age 2 and scored a 12, she had something like an 80% chance of having an allergic reaction.  In fact, the doctors at Duke are seeing a trend that their patients with lower IgE numbers are having more severe reactions than those with really high IgE levels.

So, there is a possibility that Abigail's score of 14 might mean that she would have a more severe reaction than a child having a score of 364.  I do feel that she has an advantage starting the study with a lower number. Doesn't it stand to reason that the lower the number, the less distance one has to go to get to single digits? Maybe it takes less time to build up a tolerance to peanuts with the sublingual therapy?

Here's a table that I copied from Wikipedia that shows IgE levels and their correlating allergen scores using the RAST test method.

RAST rating	IgE level (KU/L)	comment
0	< 0.35	ABSENT OR UNDETECTABLE ALLERGEN SPECIFIC IgE
1	0.35 - 0.69	LOW OF ALLERGEN SPECIFIC IgE
2	0.70 - 3.49	MODERATE LEVEL OF ALLERGEN SPECIFIC IgE
3	3.50 - 17.49	HIGH LEVEL OF ALLERGEN SPECIFIC IgE
4	17.50 - 49.99	VERY HIGH LEVEL OF ALLERGEN SPECIFIC IgE
5	50.0 - 100.00	VERY HIGH LEVEL OF ALLERGEN SPECIFIC IgE
6	> 100.00	EXTREMELY HIGH LEVEL OF ALLERGEN SPECIFIC IgE

Here are a couple of other things I learned from our many trips to Duke.  First, if a child doesn't outgrow a peanut allergy by the age of 5, he or she usually won't.  Second, IgE blood tests are not standardized.  The RAST test was primarily used from 1974, when it was invented, until 1989, when it was replaced by the ImmunoCap Specific IgE blood test.  This test may also be described as CAP RAST, CAP FEIA or Pharmacia CAP.  Wikipedia states that approximately 80% of the world's commercial clinical labs are using this newer version.  But, if you are comparing recent IgE blood test results to a previous test, you need to make sure that the labs are using the same test method.  Because the "Class" scale is assigned by the lab, unless you are comparing results using the same test method, one person's Class 3 may not be the same as someone elses.

We've got just one more visit before Abigail is on the "Maintenance Dose."  That means some relief for us on the frequency of trips.  After this next visit, we don't go again for six weeks.   Just in time for the holidays!

Another Trip...Again

Wednesday of this week we were off to Duke again for our bi-weekly visit.  I believe it's visit number 11.  It was very much a routine visit except that Abigail and I got one really good piece of news.  We are just 3 more visits away from being on the maintenance dose.  Once we hit the maintenance stage of the study, our visits are no longer bi-weekly, but will be monthly and then every 8 weeks.  That's pretty exciting for a family that drives a 300 mile day trip every other week.

By the first of December, Abigail will be taking 8 drops of the highest extract concentrate given in this study.  Here's the study protocol for the maintenance stage:

Maintenance
During the maintenance phase, your child will receive 2000 micrograms of the study extract (crude peanut extract or placebo) daily for 24 weeks at home. Your child will continue to avoid peanuts and tree nuts in his/her diet for the duration of the study.  Your child will return to the Duke Clinical Research Unit every 1-4 months for a follow up history and physical exam for the duration of the study in addition to the scheduled food challenges.

After 24 weeks we'll return for the food challenge where Abigail will be challenged up to 5 grams of peanuts (approximately 8 peanuts).  That sounds like an impossibility to me right now, and frankly, pretty scary. We'll cross that bridge when we get there.  For now, we're celebrating that soon we'll not have to go so frequently!

Four Months & Two Weeks

We had our 10th visit to Duke this week.  We've been part of the Peanut Sublinigual Clinical Trial now for 4 months and 2 weeks.  I'd like to say we were halfway done, but I can't.  We've still got over 7 months to go before we do our first food challenge.

While we were at Duke this week, a mom and son came in for their last visit before their food challenge in December.  As we get closer and closer to Abigail's challenge, there will be more weeks between visits and fewer dosage increases.  This family was up to their highest dosage and were now just going every 6 weeks.  They are going to be either the first or second participant in our study to do the food challenge.  I was all ears as Dr. Kim was describing what was going to happen on the day of the challenge.

If the kids can tolerate it, they will be given the equivalent of 6 peanuts.  The results of the first challenges that occur in December and January can really impact the study.  If the kids can tolerate the peanut flour than that's fabulous news for us.  Talk about motivation!  If there is a high failure rate, then Dr. Burks and Dr. Kim will make modifications to the study.  Not sure what that means.  Larger dosages, more frequent increases?  Worst case scenario is that we have to start over on the peanut flour study.  The doctors really don't expect that to happen though.  There has actually been an adult on a similar sublingual study who did pass the food challenge.

I asked about Abigail's blood test results from our last visit.  I wanted to find out if her IgE number had changed.  Unfortunately, the results will be locked up until the food challenge.  Even Dr. Kim will be kept in the dark.  Abigail did have another skin prick test at this visit (she did fabulous).  Dr. Kim explained how her results could actually be worse than the initial baseline.  He did 8 pricks, 5 were peanut of various strengths, 1 was the saline prick and the last two were histamine pricks (Dr. Kim thought Abigail moved so he repeated the prick).  The histamine prick serves as the control.  If there is no reaction, then the test is faulty which is what happened at our last visit.  So, we watched and waited for 15 minutes.  The histamine pricks (the two on the bottom right side of her back in the picture) immediately formed welts and large red areas around the welts.  The first 2 pricks, the higher strength peanut pricks also formed welts and red areas.  The 3rd highest strength prick formed a pimple like place and was barely worth measuring.  The 4th and 5th strength prick didn't do anything.  That's a huge change from our first test where every prick reacted.

Do we get excited??  Is she already responding to the drops?  Afterall, it's only been 4 months and 2 weeks.  I asked if it was possible for her to simply be out-growing the allergy.  According to Dr. Kim, for peanut allergies, if a child doesn't out-grow it by the age of 5, they usually don't. Okay, so I'm just a little excited.  If we hadn't had a faulty test at our last visit, I'd be a lot more excited.  I'm still hesitant to start celebrating.  However, it's hard to complain or get worked up over having to drive almost 3 hours to Duke every other week.  Instead, I feel even more blessed at having the opportunity to do this for Abigail.

What's an IgE? An Introduction....

I've been wanting to post about IgE numbers for a while, but it involves science and medicine, neither particularly strong subjects for me.  I'm on the opposite end of the spectrum with interests centering around art and design and creative thinking.  So, why even tackle the subject?  Unfortunately, it just keeps coming up.

In conversations, parents of allergic children almost always get around to telling each other what their child's IgE number and/or Class is.  It's pretty much the only definitive description we can say about an otherwise very uncertain physical condition.  My daughter is allergic to peanuts.  Her IgE number is 14.10 kU/L, and she is a Class 3.  The number is up from the last time we had her tested when she was 4.  It does not mean that she is becoming "more allergic".  Her IgE number only tells the likelihood of her having a reaction.  At a 14, I know she has a 95% chance of having a reaction if she ingests any peanut protein.  What I don't know is when or if she'll have a reaction or to what degree of severity.  I don't know if the reaction will only need an antihistamine or require the dreaded EpiPen.  I don't even know how she got her allergy or if she'll have it her entire life.  That IgE number is the only known in a very scary world of unknowns.  We parents hold onto that number.  But what is it really?

There are 3 ways to determine if someone has an allergy.  The most definitive, most expensive and most risky is a food challenge.  The patient starts with a tiny amount of food and continues to ingest until the first sign of a reaction.  If there is a reaction, then the person is allergic.  If not, they're not allergic.  Usually the amount of food is so small that a patient might just break out in hives or maybe vomit, but there is the risk of  anaphylaxis.  At Duke, whenever a food challenge is administered (at least in the clinical trials) an IV is inserted as a precaution.  Abigail is not scheduled for a food challenge until spring of 2010.

Another allergy test method is a skin prick test.  In this test, the skin is pricked and the allergen in question is applied.  If there is an allergy, the prick area swells and the skin around it gets red and itchy (almost like a mosquito bite). The test can be used for both environmental and food allergens.  While this test is uncomfortable and somewhat subjective, it is less expensive and more reliable than the next method which is the blood test.  About.com does a good job describing and comparing both of these tests in layman's terms.  According to the site, blood tests are becoming more useful in determining food allergies because they measure the specific amount of allergic antibody to a food.  The downside of blood tests, however, is they tend to give more false positives and negatives, and may indicate an elevated antibody, i.e., an allergy, which may or may not necessarily equate to an allergic reaction.  It's from the blood test that the IgE numbers and Classes are assigned. 

Blood Test (RAST, CAP-FEIA, ImmunoCAP)

The RAST test or radioallergosorbent test detects the amount of IgE that reacts specifically with a suspected or known allergen (Wikipedia).  It's an older test and many labs are using a non-radio active test like the CAP-FEIA or ImmunoCAP.  Duke University Medical Center uses the CAP-FEIA.  It's important that you know which test your doctor is using, but I'll get to that later.

So what is an IgE?  I'm using a definition from kidshealth.org for Immunoglobulin E (IgE).  It's the simplest definition I can find online.  "IgE is a type of protein in the body called an antibody. As part of the immune system, it plays a role in allergic reactions. When a person is allergic to a particular substance, such as a food or dust, the immune system mistakenly believes that this usually harmless substance is actually harmful to the body. In an attempt to protect the body, IgE is produced by the immune system to fight that particular substance. This starts a chain of events leading to allergy symptoms."  For example, airway constriction in asthma, local inflammation in eczema, increased mucus secretion in allergic rhinitis and potentially fatal drop in blood pressure as in anaphylaxis (again from Wikipedia).   However, perhaps our nurse last week at Duke explained it best.  As she described it to Abigail....the peanut soldiers think they need to fight peanuts but we're training them not to.

In a discussion with Dr. Kim at our last visit to Duke, I learned how the IgE number is determined.  Peanut protein is adhered to the inside of a test tube.  The patient's blood is then poured into the tube, left to sit for a controlled amount of time and then shaken.  The peanut antibodies in the blood will stick to the peanut protein.  In other words, the antibodies in the blood "attack" the protein in the tube much like it does in the patient's body.  The extra blood is then washed off and the blood that is attached to the protein is measured.  That amount is the IgE number.  The Class is something assigned by the particular lab running the sample.

I've found a RAST scale that I want to post.  I also want to discuss a warning about how the big laboratories use different standards when reading the results.  There's also more on the topic about what the IgE numbers actually mean, i.e., chance of out-growing the allergy and chance of having a reaction.  But, I can just picture eyes glazing over with the amount of information thus far.  So, until next time....