Two more trial participants needed for FAHF-2 in Chicago!

[booandbrimom]

i'm thinking about it, but I'm not sure my DD or DS want to participate.  Haven't asked.  I don't know how much we would need to go there --- can you give me an idea of how many visits it requires?  The one visit for the other research project at Children's Hospital was perfect for us.

I can only tell you our experience with FAHF-2 - the patch may be more or fewer visits...

We had 2 1/2 days at the beginning for all the testing, the two challenges and the first dosing. We now go back twice this summer (at 6 week intervals) for check ups. We'll go back for another 2 1/2 days in September to repeat the challenges. There will be one more checkup, and yet one MORE set of challenges in November. At some point in Q1, we'll hopefully find out whether we were placebo or real, and whether they're going to offer either new or continued medication to trial participants. (If it doesn't work...won't matter.) That will be outside the official scope, but still will require visits.

So...12 days in all, but 9 of those days are grouped within the same week. It's not terribly convenient for out-of-town.

We sort of offered it to our son as a way to make good for not having a summer job. He doesn't have the same hope for the trial that I do.

[hezzier]

This is the response I got back...


Thank you for your interest in the Ann & Robert H. Lurie Children's Hospital of Chicago Food Allergy Herbal Formula 2 (FAHF-2) study! I am following up on your email to provide you and your family with more information about our study and what you/your child's participation would entail.

This is a clinical trial testing whether the FAHF-2 drug works in treating food allergy. If FAHF-2 proves to be safe and effective, it will be the first active therapeutic treatment for food allergy.

For this study, we are looking for participants between the ages of 12-24 who are in good health and have documented positive skin and/or blood test results to peanut, tree nut, fish, shellfish and/or sesame. However, only one food allergen will be selected to be evaluated for the study. To be eligible for the study, you cannot have a corn allergy, and if you/your child has asthma, it must be controlled and not considered severe.

The FAHF-2 drug contains a mixture of 9 traditional Chinese herbs, and these have been used in China for hundreds of years. The pills are about the size of an M&M, and you/your child must be able to swallow 10 pills 3 times a day for 6 months.

This is a randomized double-blind placebo-controlled trial, which means that you/your child could be taking the drug or the placebo (the inactive pill) and neither the researchers nor the participants will know during the study which pills are being taken. By conducting the research using this method, researchers can better determine reliability of the drug and be able to make important comparisons of allergic symptoms between the group taking the treatment and the placebo group.

FAHF-2 may be available to all phase I and phase II enrolled participants at the discretion of the study investigators as a dietary supplement at the cost of the participant after the study is completed and closed if found to be effective.

Participation in the study is expected to last 9 months and in addition to taking the daily medication, it will include a total of 11 study visits with phone calls in between. Appointments are being offered at Lurie Children's, and free parking and $20 compensation are provided for each visit.

During the study, we will be doing a variety of procedures, including 2 double-blind placebo-controlled food challenges, physical exams, blood draws, skin prick testing, pulmonary function tests, and other procedures. I can answer any specific questions you may have about the procedures and what to expect as a participant, and you will learn more about these tests at your first visit.

It is important to note that the study is completely voluntary and you/your child can choose not to participate at any time. The staff consists of Children's Memorial Hospital nurses and researchers who try to make this as safe and pain free as possible.

I have included some additional details below about the study. Please give me a call at (312) 227-6458, and I would be happy to answer any more questions you may have as well as schedule a screening appointment.

When you come in for that appointment, we will further explain the study procedures and risks and benefits to you, and you will receive a consent form and an assent form for you/your child to review that also explain the study procedures and risks and benefits in detail. If you/your child decide that you would like to participate in this study, you will be asked to sign the consent form and assent form. You will be able to take the consent and assent forms home with you and discuss your decision with your doctors, family, and friends before deciding whether to participate in this clinical trial.



Sincerely,



Leslie



Leslie A. Lesner

Community Outreach Coordinator

Division of Allergy & Immunology

Ann & Robert H. Lurie Children's Hospital of Chicago

Phone: 312.227.6458

Fax: 312.227.9401

llesner@luriechildrens.org

[hezzier]

Additional info she sent...


The FAHF-2 study will include approximately 68 patients (about 20 from Chicago), and is a multi-center study being conducted at Mount Sinai in New York, Arkansas Children's Hospital Research Institute in Little Rock, and Lurie Children's here in Chicago. The study is being funded by NIH/National Center for Complementary and Alternative Medicine and Food Allergy Initiative.

Safety:

In the earlier phase clinical trial of FAHF-2 some participants have had abdominal complaints like pain, constipation, nausea, or fullness, most of which have been short-lived and appear to respond to taking the pills with meals. Trained Children's Memorial Hospital nurses and research staff will be present during all study visits, and a doctor will be on call in case of emergency. Participants will also have access to the study physician at Children's Memorial Hospital to discuss adverse events by phone, and participants can call study coordinator and physician on call during off hours.

Study Procedures:

*         An initial evaluation that includes:  medical history; physical exam; skin prick testing to the chosen allergen (peanuts, individual tree nuts, sesame, and/or individual fish or shellfish); blood draw; pulmonary function test (a breathing test); electrocardiogram (EKG); urinalysis; and a pregnancy test for girls (as needed). We do all of this in order to get baseline data so we have something to compare to at the end of the study.

*         A two day double-blind placebo-controlled food challenge, where we do a food challenge with a placebo on one day and a challenge with the allergen chosen for the study on the other day.

*         For the duration of the study, participants will take 10 pills (either FAHF-2 or placebo) 3 times daily for 6 months, complete a symptom diary, and talk to the research staff by telephone each week for the first 4 weeks, then every 2 weeks until the end of the treatment.

*         Participants will attend a study visit every 2 months (these visits will include a physical, a blood sample, a pulmonary function test, urinalysis, and routine blood tests).

*         At the end of the 6 months of treatment, there will be another study visit which repeats most of the tests done at the initial evaluation including blood tests, pulmonary function test, and skin prick test. By performing these tests after completing treatment, we can evaluate the effectiveness of the drug on the food allergen selected by comparing these results to the original baseline results from the first visit.

*         A two day double-blind placebo-controlled food challenge, where we do a food challenge with a placebo on one day and a challenge with the allergen chosen for the study on the other day.

*         For those participants who demonstrate an improvement in tolerance, a repeat food challenge will be performed 3 months after the end of the therapy to evaluate the duration of the effect.






Leslie Lesner
Community Outreach Coordinator, Davison of Allergy & Immunology
Ann & Robert H. Lurie Children's Hospital of Chicago
T 312.227.6458 | F 312.227.9401 | llesner@luriechildrens.org | luriechildrens.org
225 East Chicago Avenue, Box 60, Chicago, Illinois 60611-2605
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[twinturbo]

FAHF-2 may be available to all phase I and phase II enrolled participants at the discretion of the study investigators as a dietary supplement at the cost of the participant after the study is completed and closed if found to be effective.

For anyone planning to continue I'd suggest finding out that cost up front. I've bought it from a Sinai doctor and it wasn't cheap but I also got it in another form plus one other med for digestion which I'm assuming is set to sooth all the abdominal upset. Don't ask me how it's going because it's still sitting in my cabinet unopened due to unrelated unresolved health issues.

[David]

Hi, I know someone from my church but she is 20yrs old and is allergic to fish, cashews and pistacios. she lives in downtown Chicago. Let me know if she can join this trial. Send me an email. My email address is Davidtinku2 at gmail

[GingerPye]

You can contact lurie children's center --- the link is above -- heck, I'll put it here for you: llesner@luriechildrens.org  .  They will fill you in on all you need to know.

[ajasfolks2]

Can't seem to find the thread I wanted to put this into, but here it is.

If it belongs somewhere else, please feel free to crosspost:

http://foodallergybitch.blogspot.com/2012/10/fahf-2-holy-grail.html

[booandbrimom]

Just wanted to let you all know we're done. Nine months, 2400 pills and SIX food challenges! Yikes!

The good news is that the gains my son made in October (he was up to almost 9 peanuts at that point) have lasted. He got to one less this time around (only about 6 peanuts) but that may be because the study researchers called the challenge sooner. Apparently this time the doctor saw changes in his throat/mouth that concerned her enough that they didn't wait for him to get to the really uncomfortable point.

Unfortunately, no one really knows how long the effect lasts. In traditional Chinese medicine, this is apparently something that people would take life-long. It had the reputation for not only increasing threshold, but for also decreasing the severity of allergic response. That would be of value to everyone in the food allergy community, even if a child still couldn't eat his or her allergen(s).

Let me know if you have specific questions. It sounds like it's still not going to be available for a couple of years, as they are going the FDA route for commercialization. Phase 3 trials (with the reformulated drug -- way less pills) will be in Texas.

[CMdeux]

Hey, Boo-- that is GREAT news.  Congratulations to your guy for doing this; that is one heck of a lot of pills.

  I hope that the effects are very slow to wear off. 

Do you have any notion who might be heading up trials in TX?  Just wondering since Wasserman's group seems to have gone with early commercialization of rapid desensitization, which makes it less likely that they'd tackle this as well.  Of course that could be a totally wrong assumption on my part, too.

[Mookie86]

Congrats!  I hope the effects last a long time.

[booandbrimom]

Do you have any notion who might be heading up trials in TX?  Just wondering since Wasserman's group seems to have gone with early commercialization of rapid desensitization, which makes it less likely that they'd tackle this as well.  Of course that could be a totally wrong assumption on my part, too.

Nope, no clue. I don't think she mentioned the institution, other than to say Texas. It's not posted yet for recruitment.

[Cal Mom]

Hi Booandbrimom,

It's been a while since your last post on this forum.  Can you update us on your son's condition?  Has the FAHF-2 effect worn off?

Thanks!

[booandbrimom]

I do keep up the blog, although I haven't been writing much lately. I have a job from hell at the moment.

My son is doing great and continues to eat everything we've tried. We did an at-home challenge a couple weeks back for pinto and white beans. He passed both. He's now eating the pinto beans every time he goes to Chipotle. The doctor asked that we hold off on black beans because he's still Class 3 for those, but we can probably broaden these over times.

He's eating all soy without a problem. He's eating baked milk, although I have not been doing as much with this as I need to because of work. We need to introduce baked cheese and schedule an open milk challenge.

If he passes milk, he will only have the peanut allergy left...and since he doesn't have to avoid "may contain" foods, that's really not even an issue.

We did hear from the study that they had completed the trials and that he was on active medication. I asked when they would be publishing results and they didn't have an answer. We also don't know if the medication will be available again. Honestly, I'm not sure what we'll do even if it is available since he's doing so well.

The very hardest part of all this has been undoing all the avoidance behaviors we've learned over the last 18 years. That's still a huge work in progress.

[Cal Mom]

Thanks so much for taking the time to write back!

I'm glad to hear that everything is going well with your son.  Some questions:  you mentioned that your son eats soy, baked milk and some beans now.  Did your son have reactions to these foods before he started on FAHF-2?  What I mean is right before he started FAHF-2 had he been exposed to these foods and had a reaction? 

Also, if you don't mind sharing: Did his RAST numbers for soy, milk and beans change during the FAHF-2 trial? 

Thanks a lot!

[booandbrimom]

you mentioned that your son eats soy, baked milk and some beans now.  Did your son have reactions to these foods before he started on FAHF-2?  What I mean is right before he started FAHF-2 had he been exposed to these foods and had a reaction?

Well...this is the tricky part. We don't really know where his allergies were at with regard to these foods when we started the trial. His last big milk reaction was age 8, so almost 10 years. Soy was freshman year in high school, so only 3 years previously. His last pinto bean reaction was probably age 6.

So yes, he had reactions (some quite serious) to all these foods in the past. However, it's possible he just outgrew them all as part of the natural aging process and not related to the FAHF-2.

The trial didn't track numbers for all allergens - just for peanut, so we also don't know what happened to his numbers during the trial. However, he was tested by his own allergist before and after the trial. His milk numbers have not changed much - he is still Class 3. Soy also has not changed much - I think he was Class 1 last time we went. Those particular two types of beans were also Class 1.

We've concluded that numbers really don't seem to mean much for him. His allergist really doesn't want to do an open milk challenge at this point because his numbers are still very high, but we're pushing to have it done. We all just need to know.

Whether the medication has made the big difference, or whether this whole trial experience has simply given us the courage to push through our own anxiety about introducing foods doesn't even really matter to us. The effect is the same. I wish so much that we had been more aggressive about all this when he was younger.