Skin Patch Test for Irritable Bowel Syndrome
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications like cortisone or immunosuppressive drugs two weeks before and during the study. If you're on a low FODMAP diet, you'll need to stop that one week before and during the study as well.
What data supports the effectiveness of the IBS Skin Patch Test treatment?
Is the IBS Skin Patch Test safe for humans?
How does the skin patch test treatment for IBS differ from other treatments?
The skin patch test treatment for IBS is unique because it identifies specific food sensitivities that may trigger symptoms, allowing for a personalized avoidance diet. This approach is different from standard IBS treatments, which typically focus on managing symptoms rather than identifying and avoiding specific food triggers.12346
What is the purpose of this trial?
Participants with IBS are skin patch tested (no needles) to 80 different foods and food additives, compounded for patch testing, in search of food allergies. The testing requires 3 office visits within a 4 or 5 day period. The patches are taped to the back at Visit #. At Visit #2 48 hours later, the patches are removed from the skin and the outside border of each patch is marked with a felt tip marker. At Visit #3 (final visit) 1 or 2 days later, the patch test reading is performed by the doctor-investigator. An allergy is identified as a small red mark where the food was in contact with the skin for 48 hours. Those participants found to have food allergies are then placed on an avoidance diet (no calorie restriction) for 16 weeks where they either avoid eating the food(s) to which they are allergic (the \"true\" avoidance diet) or food(s) to which the testing did not show an allergy (this is called the \"sham\" avoidance diet). There is a 50/50 chance of going on either avoidance diet. The avoidance diet is assigned in such a way that neither the participant or the doctor-investigator knows which diet is being followed. After the 16 weeks, the participants answers a brief online questionnaire that asks about the IBS symptoms while following the avoidance diet. After the 16 week avoidance diet and final questionnaire are completed, those participants who were on the sham diet will be told of their true food allergies which they may try avoiding on their own.
Research Team
Michael B Stierstorfer, MD
Principal Investigator
North Wales Dermatology, PLLC
Eligibility Criteria
This trial is for individuals with Irritable Bowel Syndrome (IBS) who are interested in finding out if food allergies might be contributing to their symptoms. Participants will undergo skin patch testing for various foods and additives, but they must be able to visit the office three times over a few days.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Patch Testing
Participants undergo skin patch testing to 80 different foods and food additives over 3 visits
Avoidance Diet
Participants follow a 16-week avoidance diet based on patch test results, either true or sham
Follow-up
Participants complete a post-avoidance diet questionnaire to assess IBS symptoms
Treatment Details
Interventions
- IBS Skin Patch Test Food Allergy Study
Find a Clinic Near You
Who Is Running the Clinical Trial?
IBS-80, LLC
Lead Sponsor