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invited to participate in research study

274 replies [Last post]
By melissa on Wed, 02-08-06, 03:09

tarheelmom,
Welcome! I will try my best to get back on the board tomorrow and explain our first day in the study and his reaction (which by the way was the worst so far of the study participants I believe)...I just jumped on the board quickly tonight and am going to bed as I've had a bit of a bug the past couple of days and I'm just tired. But I promise to get back to you asap.
Were you at the parent info meeting last month at Duke?
Melissa

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By TarHeelMom on Wed, 02-08-06, 04:20

No...I wasn't at the meeting. Thanks in advance for your info!!

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By J&D on Mon, 03-20-06, 21:01

Hi Melissa,
Firstly thanks for setting up this topic, sharing with us your experiences, and providing hope to us and countless others that someday we may have a solution to this problem.
Our DD is allergic to peanut, walnut and cashews. It sounds like this particular study is only looking at PA, but it would be interesting to know if any of the other participants are also allergic to tree nuts, and if so has there been any evidence to show that this treatment also helps to remedy tree nut allergies.

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By melissa on Tue, 03-21-06, 01:53

J&D,
I don't think what we are doing specifically w/ pn would help w/ any tree nuts, but I would assume if it works w/ pn the same process could be done w/ tn too (and other foods, as they are already doing it w/ egg). I did ask before the study that if DS ends up being allergic to tree nuts, what good would it be to get rid of the pn allergy? Dr. Burks said that it is much less common to find tn at schools, events, etc...much more common to have to deal w/ pn, and that made sense to me.

To all,
We head back to Duke Wednesday for the 1 yr check. DS has to have a skin test and blood test (not looking forward to that)...we are of course doing the regular pn check and I'm very hopeful that his #s will drop by at least 1/2 as the other participants have done (would bring his # from a 25 to around a 12-14). We are also, on the side, running the RAST for fish, shellfish, maybe tree nuts, and of course for egg. I would LOVE it if the egg went down as well..he is at 4 right now and I'm ready to get rid of this allergy...so, I'm hoping and praying for both pn and egg to go down and for no other allergies. We will also be meeting informally w/ Dr. B for a Q and A session...will post any updates.
Melissa

[This message has been edited by melissa (edited March 21, 2006).]

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By multiallergymom on Tue, 03-21-06, 03:55

I hope you get every single one of your wishes. Good luck.

Thanks for doing this. It gives me a lot of hope.

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By melissa on Thu, 03-23-06, 20:41

Back from Duke w/ nothing major to report yet. DS was a real trooper w/ the blood test...barely whimpered...said it didn't hurt (they used EMLA cream) but he didn't like people messing w/ him. We of course did the peanut test, plus tested for eggs to see if it's gone down, and tested for fish and shellfish, just to see if it's ok to try those things (I figure if we're drawing blood anyway, may as well find out what we can!). The skin test looked about the same as last time...no bigger, no smaller, except 2 of the places (they do a titrated test w/ decreasing amounts of pn) near the weakest pn amount had no wheals this time, only small flares. The nurse said not to worry about no real change in the skin test, saying "that's always the last to go". We should have results in 1-2 weeks. Unless DS goes below a 2 on his RAST, we will come back in May and start going up higher, w/ the ultimate goal being 1800 mg, or the amount in 6 peanuts, or 3 teaspoons of peanut protein.
I'll let you know when we get results.
Melissa

[This message has been edited by melissa (edited March 23, 2006).]

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By starlight on Fri, 03-24-06, 00:25

Melissa-

I think it's awesome you're involved in this study, I've been following the post since you started it.

I have a question though...when you get up to the equivalent of 6 peanuts, will your son go off of it? My question with the research is that if he can tolerate 6 peanuts, and he's taking these peanut pills, and gets accidentally exposed to a peanut, would he react to the extra peanut since it wasn't gradually introduced? It would seem to make sense to take him off it when his immune system will accept the 6 peanuts, but then without the continuing exposure, will his tolerance level drop again?

Sorry if I'm not making sense, got a headache today =/ If you don't understand, let me know and I'll try to re-explain.

Thanks [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]

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By melissa on Wed, 04-12-06, 22:06

One year numbers are back...
DS went from a 25.6 in September to a 15.8 now, a drop of about 38%...he should drop again at 18 mos, but the kids in the study are not dropping at 24 mos, so they want to go ahead and push higher w/ the dosage in hopes to push the numbers down lower...we will probably start this the end of May or beginning of June.

Starlight,
I just realized I never answered your questions...let me think about it and get back to you...it may be week after next as we are going on vacation.

Melissa

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By melissa on Sat, 04-22-06, 22:37

Just found out we go back to Duke May 17 for the next big step...will post more when I have time, but basically we start out at 300mg (where we are now) and go up (and up and up hopefully). Very nervous though.
Melissa

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By melissa on Thu, 05-04-06, 23:04

Hi,
For anyone actually keeping up w/ this, our date to go to Duke has been changed to May 24-25. I am very nervous about it, but am hopeful too, for reasons included in this message. We will start at 300 mg (the dose he's on now, 1 peanut), go up by 150 mg I think, every 1/2 hour, then by 300 mg if he gets to 1200 mg, until he gets to 1800 mg, which is about 6 peanuts. He will have an IV again, and any sign of a reaction will stop the challenge. Then he will come back the next am for the 600 mg dose again, which he will go home on, regardless of how high he gets.
Now, here's the exciting part: they have started the new phase w/ 2 kids so far. One had lower RAST numbers and one had higher RAST numbers than Justin. Both kids made it all the way to 6 peanuts w/ absolutely no reaction! I am so hopeful that Justin follows suit! If we get to 6 pns, then we only have to go back once every 4 months for increased doses for the rest of a year. If we don't, then we'll be going back once a month.
I will post as soon as we get home from the appt, and if any more challenges are done before us, I'll post those results as well.
Melissa

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By J&D on Thu, 05-04-06, 23:48

Following this topic has become one of our daily rituals - Thanks again for doing this.
This study sounds very promising, we live in Australia (Melb) and to our knowledge there is no such study being performed here. If it is not too much trouble could you find out if they plan to roll something similar in other countries - Thanks.
All the very best for the 24-25th.

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By Wildone1 on Fri, 05-05-06, 14:56

I would think the success of this program thus far increases the probability of it becomming the typical process of fighting PA.

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By starlight on Fri, 05-05-06, 15:38

The 6 peanut thing is so cool. If this is approved, it's gotta be cheaper than xolair [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]

So the challenge is more of what he's already getting. I'm a little confused on what it is he's actually getting. Is it real peanut protein or is it synthetic? Have they given a real peanut to a kid as a challenge yet?

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By melissa on Fri, 05-05-06, 16:26

starlight,
What DS eats is real peanut...it is ground up peanut and actually comes from a peanut factory in Georgia. They had even discussed at one time switching to peanut butter but decided against it for now. You mix the peanut stuff (it looks like really heavy flour) in something, like yogurt, applesauce, etc for him to eat.
Hope I answered your question...I can never remember everything someone asks when I go to reply!
Melissa

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By melissa on Mon, 05-08-06, 23:37

J&D,
I will try to remember to ask Dr. B about what options might be available in other countries at our appt on the 24th...
Melissa

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By TJuliebeth on Tue, 05-09-06, 01:40

Melissa...just chiming in to let you know I (and I think many others to) always look for your updates...I find this study soooooooo encouraging...Thanks so much for keeping this thread up to date!

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By Danielle on Tue, 05-09-06, 19:00

Looking forward to hearing from you after your next visit. Sounds exciting. Thx for all the updates.

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By Wildone1 on Wed, 05-10-06, 17:49

I have not heard of any major reactions or complications with this process. Have any of the patience suffered significant reactions?

It appears this is obviously working...what are the kinks that have to be worked out? I guess I'm trying to think of the reason(s) why this therepy would not become common tactic for PA.

Any downsides?

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By lhua on Wed, 05-10-06, 19:49

Quote:Originally posted by Wildone1:
[b]I have not heard of any major reactions or complications with this process. Have any of the patience suffered significant reactions?

It appears this is obviously working...what are the kinks that have to be worked out? I guess I'm trying to think of the reason(s) why this therepy would not become common tactic for PA.

Any downsides?[/b]

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By lhua on Wed, 05-10-06, 19:51

Does anyone know if they are planning to test this with tree nut allergy?

Thanks

Lingling

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By melissa on Fri, 05-19-06, 23:24

Originally posted by Wildone1:
I have not heard of any major reactions or complications with this process. Have any of the patience suffered significant reactions?
It appears this is obviously working...what are the kinks that have to be worked out? I guess I'm trying to think of the reason(s) why this therepy would not become common tactic for PA.

Any downsides?

Wildone1 and lhua,
sorry so long to respond...the reactions have mostly been minor, ours being bad as far as I'm concerned...DS needed epi, but mainly because his IV blocked up and we could not get him to take the Benadryl...he had lots of hives, was barking, very sleepy...most of the original 12 kids in the study needed Benadryl on the first day, we needed epi, and I think one needed albuterol.
I think the hold up is that they need to get more kids into the study...something to do w/ getting enough percentages to be able to report (I don't know all the research mumbo jumbo)...plus, the way the study works now, this is a long, long process...they are constantly "tweaking" it to try to make it quicker and keep it as safe as possible.
When we started the study, Dr. B said if you asked all allergists if this would work, 1/2 would say maybe, 1/2 would say no. He is travelling around a bit giving presentations to allergists and pediatricians explaining the study and protocol and basically recruiting.

As far as for tree nuts, I don't know...I know Duke is doing it for egg and pn, Arkansas too, and maybe for milk...the thought was though that if it works for one food it should work for any food.
See my next post about how the study is changing a bit now.
Hope this answers your questions,
Melissa

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By melissa on Fri, 05-19-06, 23:36

Just a short update:
DS has had a cough for over a week that has turned into bronchitis...he started an antibiotic yesterday...still planning to go next week IF his cough is basically gone and his tummy doesn't hurt from the antibiotic (we have to be able to tell what is causing any symptoms he might have)...so cross your fingers that he gets over all this...he can't be on his Zyrtec until after we go and that's not helping matters.

Regarding the study, the protocol has changed a bit. Here is the dosing schedule (scary scary scary)...
1---300 mg (his current dose, 1 peanut)
30 mins later---600 mg (2 pn)
30 mins later---1200 mg (4 pn)
30 mins later---1800 mg (6 pn)
If there is any teeny bit of a symptom, we will wait longer in between doses; any reaction above something very minor and we will stop. We will stay 2 hours after the last dose unless he has a bad reaction, in which case we'll stay 4 hours.
Then we return the next AM to repeat the 600 mg dose, wait 2 hours, and then go home on that dose for 4 months.
IF DS is not well enough to go, I'll post it by Tuesday.
Thanks,
Melissa

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By Danielle on Sat, 05-20-06, 03:47

If there is any teeny bit of a symptom, we will wait longer in between doses; any reaction above something very minor and we will stop. We will stay 2 hours after the last dose unless he has a bad reaction, in which case we'll stay 4 hours.
Then we return the next AM to repeat the 600 mg dose, wait 2 hours, and then go home on that dose for 4 months.

After reading the above, I am concerned since so much that I have read talks about bi-phasic reactions. Much more severe and requiring immediate attention. I am assuming they would keep you for 8 or more hours. I know I have read that the studies for a possible bi-phasic reaction has recently increased and therefore longer obsrvation time by medical staff is needed.
Just wondering about this. I know you are in the best of hands but I wonder what their protocol is.
Our last ER visit for a possible milk allergy ended up with me telling the ER Dr that I would just wait in the parking lot if they wouldn't let me stay longer in the ER. 12 hours later we ended up in a diff hospital with worse symptoms.... possible bi-phasic or could have been meds wearing off. I will never know.
As always, wishing you the best of luck.... you are courageous.

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By melissa on Mon, 05-22-06, 21:43

Well, we have been postponed...Justin got sick last week and then it turned into bronchitis...he's basically well now but still coughing; Dr. B wants his lungs clear for the best results. I completely understand but I'm bummed...I want to get it over w/...the anxiety of it hanging out there is killing me.
Will update.
Melissa

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By melissa on Mon, 05-22-06, 21:54

Oh, I was so busy wallowing in my self-pity that I forgot...they challenged another child today and he went all the way to 1800 mg as well (3 for 3)...he had just a bit of itchiness.
melissa

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By Sirimon on Tue, 05-23-06, 03:53

Dear Melissa:

I don't write often but always read your posts. Just want to let you know we are rooting for you. I am excited to get new info each time you write.

We are very interested in the study. Unfortunately, when I called, Dr. Burks were not yet willing to enroll anyone living more than 3 hours from Duke for safety reasons. He wants to get more data before considering that.

It's great to hear that the kids are tolerating big doses. This is great news. I wish you and your DS all the best. Please let us know how it goes.

Sirimon

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By melissa on Tue, 05-23-06, 22:39

New date: June 21...I am not thrilled that it is that far off (which means another whole month of anxiety) but that is the first date we could coordinate all schedules. Will update as we get closer and as others go through their challenges.
Melissa

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By melissa on Thu, 06-22-06, 18:44

We're back...you need some background info to follow this:
1 peanut = about 300 mg, so 2=600, 3=900, etc.
Doses are given each 1/2 hour, so after an hour there is a current dose but also a cumulative amount of peanut in the system.

Ok, he did well, we're still "underachievers" but that's ok. He was a champ w/ his IV, took his normal 300 mg dose (1 peanut), 30 minutes later took a 600 mg dose (2 peanuts, but a cumulative amount of 900 mg or 3 peanuts in his system)...absolutely nothing! Then 30 minutes later, the whopper...1200 mg (4 peanuts, 2100 mg cumulative in his system)...he got a little red around his mouth after a few minutes, then he coughed a bit, his mood changed (sleepy, quiet). Dr. Burks was in there w/ us at this point and said it was time to stop. He was given Benadryl, cleared up, then about 20 mins later started a slight reaction again (coughed some, a little quiet, eyes a bit puffy)...we watched very closely, of course vitals were monitored very frequently. This secondary reaction cleared up on its own.
While I'm disappointed that we didn't make it to the 1800 mg dose, when I compare now w/ March 2005, I'm thrilled. When we first started then, he required epi w/ a 12mg dose and a cumulative amount of about 24mg in his system...his throat was closing, he was barking, in great distress, and covered head to toe in hives. Now, w/ 2100 mg in his system, he had a much less severe reaction, just 2 hives, and only required Benadryl. Best of all, he handled 3 peanuts (900mg) w/ zero symptoms.
We stayed 4 hours after his last dose and went back to the hotel...he was fine, went swimming, played. Went back this am for the 600 mg dose again, which he returned home with. Again, no symptoms. So now he will take 600 mg daily (2 peanuts) for 4 months, go back for blood work and try the 1200 mg dose again (which should be ok this time w/out the cumulative amount in his system and after 4 months of the 600 mg dose).
Big relief....still allergic, but getting there very slowly.
I will try to post more tomorrow (answers to some of your questions)...hope this all made sense!
And as I posted in Main and Media, Dr. Burks and this study will be on Good Morning America Friday June 23 (tomorrow) AM.
Melissa

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By jtolpin on Thu, 06-22-06, 19:07

Rest now... Hugs

When you get back, to reading, I have 1 question...

How do you KNOW (REALLY know) what is helping your child toelrate more peanuts?

It could be the body 'maturing', couldn't it? Couldnt it be ANYTHING else? I dunno.

Don't get me wrong though - I commend you for being in the study... I remember US in the Elidel study yrs ago, pre-fda approval... I know the stress of it (though it, I am SURE, was NOT as stressful as yours...)

I look forward to more notes from you, and hearing in GMA.

Hugs!

Jason

------------------
[b]* Obsessed * [/b]

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By multiallergymom on Thu, 06-22-06, 19:28

Congratulations! I think what you are doing is great.

I'm sure it was very stressful. Try to have a great weekend.

Thanks for the heads up on the GMA spot.

When will the RAST again?

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By lilpig99 on Thu, 06-22-06, 19:47

So glad to hear he tolerated more...that is a good step forward isn't it. And that's what you were hoping for...more tolerance! Good good good!!!

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By Wildone1 on Thu, 06-22-06, 20:23

Congrats, Melissa and give your boy a high five from me.

I'm curious. Have you found yourself under a lot less stress related to the risk of cross-contamination since you found out he can eat one peanut? FOr instance, do you let him eat "May Contain Traces" food items? If not, now that he can eat two peanuts, will you put your guard down a little?

God Bless

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By LuvMyKids on Thu, 06-22-06, 20:39

Even if he didn't get up to six peanuts, I'm so amazed by his progress and think it is wonderful.

I'm curious, what is happening with his egg score as the peanut RAST has gone down. Has Dr. B mentioned how this might affect other food allergies for those who are dealing with more than peanut?

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By VariegatedRB on Thu, 06-22-06, 22:13

Okay- I am being lazy and don't want to go back through the thread... but isn't this a double-blind study? Some kids getting peanut and others getting a placebo?

If so we will know whether it is working or not- we would only see the kids in the experimental group improving (or would see greater resonse t least).

Tara P

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By VariegatedRB on Thu, 06-22-06, 22:15

And congratulations, Melissa, BTW, it is great news!

Tara P

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By starlight on Fri, 06-23-06, 01:07

That is so awesome! I mean, even if he's only on the 600mg dose, does that mean that he can conceivably be eating "may contains" now? Since he went up to 3 peanuts with no reaction and he's only on a dose of 2 peanuts, then he could tolerate the traces in the may contains! Oh, that's just too cool.

I know chicago hospitals just got a lot of funding for PA research, does anyone know if one of these studies is happening around Chicago? Or in Omaha?

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By alliedhealth on Fri, 06-23-06, 01:54

It is not a double-blind study- some of the previous studies (not by Dr. Burks) where there were placebo and control groups is where there were adverse outcomes. In this study the researchers know the dose each child is getting.
We are very encouraged by your results Melissa. Take care and we'll keep the prayers going

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By Sirimon on Fri, 06-23-06, 21:01

I am soooo... happy for you. This is so encouraging. Please keep us updated. Get rest and take care.

Sirimon

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By kandomom on Fri, 06-23-06, 21:36

Wonderful news for you and your son Melissa! Thank you both again . . .

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By melissa on Sat, 06-24-06, 00:17

Everyone,
I will try to answer questions that have been posted over the weekend...I'm just taking a little "peanut allergy" mental health day (or 2)! [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img] But feel free to post any questions.

Melissa

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By njm on Sat, 06-24-06, 01:26

Do you know if any of the children in the study had anaphylactic reactions prior to participating? Also, do you know if any of the children are asthmatic? Is there any hope that desensitization would work for those who have wheezing/breathing issues upon consuming (or even being around) peanuts?

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By Shely on Sat, 06-24-06, 22:00

Hi Melissa!

This is the first time I have posted, however, I have been following this thread for a long time. I just wanted you to know that there are a lot more people following your posts that do not reply here. Your story has been a beacon of hope for me and many others. We are all so busy and it would be easy, and very forgiveable, if you did not find time to post here.

I thank-you from the bottom of my heart for making this effort. Please tell your son that he is helping so many boys and girls that are just like him and that my son thinks he is a real hero.

Thanks so much.

I probably won't post again but I most certainly will be following your journey. Good luck with the rest of it. You have come so far for all of us.

Noah's Mom

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By mistey on Fri, 06-30-06, 02:58

Ditto. I have followed intently since day one. I'm glad to hear that your little one (and you!!) are doing well. So you go ahead and take a well-deserved break!!

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By melissa on Fri, 06-30-06, 12:48

I promise promise promise I will attempt to answer all the questions posted in the last couple weeks this weekend...DS came down w/ a throat infection and high fever last weekend that lasted for 4 days and then I've taken older DS to a camp every day and taught bible school every night...will get back here soon though!
Melissa

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By Danielle on Fri, 06-30-06, 20:42

WOW
Just read your last update.
I am so happy for you and your son. I say a little prayer for you often to keep him safe and to say thank you for your courage. I hope this leads a path for all of us to follow.
Looking forward to more posts.

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By melissa on Sun, 07-30-06, 18:58

Yes I know how lame I am for not answering questions earlier...my PA mental health break stretched into bible school, sick kid, swimming and tennis lessons, getting a part time job and going back to work, etc etc.
So, many apologies and let me see how I do at this:
1. DANIELLE:
you asked about biphasic reactions. The protocol says a child has to stay at Duke for at least 4 hours after a reaction. We did this both times (right at 4-5 hours)...DS did have a biphasic rxn this time; after his initial rxn and taking Benadryl, about 30 mins later he started to react a bit again; Dr. B was in the room and we just watched him. His symptoms stopped on their own w/ no more meds.
2. WILDONE/STARLIGHT:
Has our comfort zone changed and do we allow may contains? No. We act like nothing has changed. Part of the protocol is that DS is to not "knowingly" consume pn products so we still avoid; however, while I will still be nervous, I will feel much better when he goes to preschool this fall and not worry about a life threatening accidental exposure. I also have found myself not being as nervous about what other kids around him are eating, say at the pool, or at a church social.
Starlight, I don't know of anywhere doing this particular study outside of Duke and Arkansas.
3. LUVMYKIDS:
You asked how this was affecting his egg score. His egg RAST has gone from a 4 to an 8, which the dr says is no big deal (still in the same class anyway)...He compared it to shots...if you are allergic to cat and dog and only get shots for cat it does not make the dog allergy worse. so supposedly one has no effect on the other. still have my fingers crossed that the egg will be gone when we retest in October.
4. VARIEGATEDRB:
No this is not a double blind study. However, this part of the study will soon be closed and the next part (for new enrollees) will be dbl blind.
5. NJM:
Yes some of the children had prior anaphylaxis before entering the study and some are asthmatic (can't remember but I believe 3-4 of the original 12 have asthma).
6. JASON:
Saved you for last b/c you always give me a challenge LOL!
How do I really know what is helping DS tolerate more pn? That is a hard one to answer. I guess the proof is in what i've seen...w/ each increase he would get some symptoms for a day or 2, then no more...proof that we have to go up very incrementally b/c his system is working to "identify" peanut and then hopefully outgrow the allergy. In addition, ALL the children in the study are following the same pattern...they all got some form of mild symptoms up until about 150 mg dose, then no more symptoms, then had some sort of reaction when we entered the next phase going up to as high as 1800 mg, then no more symptoms after a couple days. Plus everyone's RAST is so similar...I think all of the original 12 had slight increase in RAST score at the 3 mos check, then a decrease, and all had a 40-60% drop at the one year level...everyone is following a very similar pattern. So I just don't see how it could be chance that these 12 kids (more now) just happen to be doing the same thing at the same points in the study when they all started at different ages and w/ different RAST numbers. Make sense?

Ok, I think I covered all the questions. If I left someone out, sorry, and ask me again.
I don't have any more updates for you and may not have any until October. DS is doing well on his dose...no symptoms at all (remember he is on 600 mg, or 2 peanuts a day).
Melissa

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By jtolpin on Tue, 08-01-06, 09:15

TYVM. Good luck!

Jason

------------------
[b]* Obsessed * [/b]

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By luvmyboys on Tue, 08-01-06, 12:35

Melissa, Have you met a Dr. Green there? Supposedly he was a resident working with your dr. He is now coming to Pittsburgh Children's. Thanks, Luvmyboys

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By luvmyboys on Tue, 08-01-06, 13:51

Double Post

[This message has been edited by luvmyboys (edited August 01, 2006).]

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By melissa on Tue, 08-01-06, 18:10

Luvmyboys,
Todd Green? Yes he has been in w/ us several times...I didn't know he was leaving. He's nice, very quiet, has 3 very young kids I think. He's kind of like Dr. Burks in that he seems quiet and cautious...I think you'll like him and he has certainly had good training!
Melissa

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