NCT06288672

IBS Skin Patch Test Food Allergy Study

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Patch Test-Guided Type 4 Food Allergen Dietary Avoidance for Irritable Bowel Syndrome
IBS-80, LLC·ClinicalTrials.gov·otherRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Irritable Bowel Syndrome
Drug/Device/Intervention
True avoidance diet
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
IBS-80, LLC
Location
Marlborough,Westford,New York,New York,North Wales,Barboursville, United States of America
Timeline & enrollment
Phase
N/A
Start date
Aug 15, 2023
End date
Dec 01, 2025
Enrollment
250 participants
Primary outcome

Post-Avoidance Diet Relative IBS Symptom Global Assessment

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.

ICD-10 classifications
Irritable bowel syndromeOther and unspecified irritable bowel syndromeIrritable bowel syndrome with mixed bowel habits [IBS-M]Irritable bowel syndrome with predominant constipation [IBS-C]Irritable bowel syndrome with predominant diarrhoea [IBS-D]
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06288672
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06288672 through Pure Global AI's free database. This phase not specified trial is sponsored by IBS-80, LLC and is currently Recruiting. The study focuses on Irritable Bowel Syndrome. Target enrollment is 250 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.