IBS Skin Patch Test Food Allergy Study

Conditions

• Irritable Bowel Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• True avoidance diet — OTHER
  Food patch test-directed avoidance diet for 16 weeks where participant avoids avoid eating the food(s) to which they are allergic
• Sham avoidance diet — OTHER
  Avoidance diet for 16 weeks of randomly selected foods to which the patch testing did not show an allergy

Study Details

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.

Key Dates

Start date

Aug 15, 2023

Status verified

Dec 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Post-Avoidance Diet Relative IBS Symptom Global Assessment [ Time Frame: Questionnaire to be completed promptly after completion of 16 week avoidance diet. ]

Central Contacts

• Michael B Stierstorfer, MD
  215-699-1929
  [email protected]
• Sally Iles, BSN, MBA
  617-922-1130
  [email protected]

Locations (2)

Find similar trials in North Wales, PA

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