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ID06288672

Study of Patch Test-Guided Food Allergy Avoidance Diets for Treating Irritable Bowel Syndrome

Led by IBS-80, LLC · Updated on 2025-12-17

250

Participants Needed

2

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a skin patch test method to identify food allergies in people with Irritable Bowel Syndrome IBS. The study aims to understand if avoiding foods that cause allergic reactions can help reduce IBS symptoms. This is a randomized, double-blind study conducted by IBS-80, LLC, where neither participants nor doctors know which diet is assigned during the treatment period. Participants undergo skin patch testing for 80 different foods and additives across three office visits within 4 to 5 days. After identifying food allergies, participants are randomly assigned to follow one of two 16-week avoidance diets either avoiding foods they are allergic to true avoidance diet or avoiding foods without allergies sham avoidance diet. After completing the diet, participants complete an online questionnaire about their IBS symptoms. During the study, participants have three visits for skin patch application, removal, and reading. The study monitors IBS symptoms through a questionnaire completed after the diet period. Those on the sham diet are later informed of their true food allergies and may choose to avoid those foods. The total participation lasts about 18 weeks, including the testing and diet periods. Results will be analyzed once all 250 participants complete the study.

CONDITIONS

Brief Title

IBS Skin Patch Test Food Allergy Study

Research Team

M

Michael B Stierstorfer, MD

S

Sally Iles, BSN, MBA

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