Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06288672

IBS Skin Patch Test Food Allergy Study

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

250

Participants Needed

2

Research Sites

172 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

IBS Skin Patch Test Food Allergy Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Irritable Bowel Syndrome by a primary care provider, gastroenterologist, or allergist; or meeting Rome IV IBS criteria with poorly controlled symptoms
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Pregnant
  • Have a severe rash
  • Taking cortisone or immunosuppressive drugs within two weeks before testing or during the study
  • Unable to complete all parts of the 18-week study, including diet and questionnaires
  • Exposed back skin to sun in the two weeks before patch testing
  • Unable or unwilling to stop a low FODMAP diet starting one week before and during the study
  • Refuse to shave back hair if needed
  • Started or changed IBS medication within 30 days before enrollment
  • Non-English speaking
  • Unable to provide written informed consent
  • History of certain gastrointestinal diseases active in the past two years
  • History of gastrointestinal surgery except appendectomy or gallbladder removal over six months ago
  • Poorly controlled severe psychiatric illness
  • Excessive alcohol use (more than 1 drink/day for females, 2 drinks/day for males)
  • Use of illicit drugs
  • Use of high-dose opiates
  • Severe allergy to adhesive tape

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

North Wales Dermatology, PLLC

North Wales, Pennsylvania, United States, 19454

Actively Recruiting

2

Shepherd Allergy

Barboursville, West Virginia, United States, 25504

Actively Recruiting

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Research Team

M

Michael B Stierstorfer, MD

CONTACT

S

Sally Iles, BSN, MBA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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