A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Patch Test-Guided Type 4 Food Allergen Dietary Avoidance for Irritable Bowel Syndrome

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Irritable bowel syndrome diagnosed by a primary care provider, gastroenterologist or allergist; or

• meeting the Rome IV IBS diagnostic criteria by history and having suboptimally or poorly controlled IBS symptoms.

Locations
United States
Pennsylvania
North Wales Dermatology, PLLC
RECRUITING
North Wales
West Virginia
Shepherd Allergy
RECRUITING
Barboursville
Contact Information
Primary
Michael B Stierstorfer, MD
mbstierstorfer@gmail.com
215-699-1929
Backup
Sally Iles, BSN, MBA
sallyiles3@gmail.com
617-922-1130
Time Frame
Start Date: 2023-08-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 250
Treatments
Active_comparator: True avoidance diet
Food patch test-directed avoidance diet for 16 weeks where participant avoids avoid eating the food(s) to which they are allergic
Sham_comparator: Sham avoidance diet
Avoidance diet for 16 weeks of randomly selected foods to which the patch testing did not show an allergy
Related Therapeutic Areas
Sponsors
Leads: IBS-80, LLC

This content was sourced from clinicaltrials.gov