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NCT Number: NCT06288672

IBS Skin Patch Test Food Allergy Study

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Wales Dermatology, PLLC, North Wales, Pennsylvania, United States

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About this study

See above. When all 250 study participants have finished all parts of the study, the results will be made known to the doctor-investigators for data analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Under age 18 years
  • Pregnant
  • Severe rash
  • Receiving any cortisone-containing or any of the following immunosuppressive medications within two weeks prior to patch testing or plan to do so any time during the study: cyclosporine, mycophenylate mofetil, azathioprine, tacrolimus or others within these classes of medications)
  • Incapable of completing all parts of the 18-week screening period and study, including following the dietary instructions and completing all text or email questionnaires
  • Exposure of back to the sun in the 2 weeks prior to patch testing Unable or unwilling to discontinue the low FODMAP diet, if relevant, starting 1 week prior to the study and for the study duration
  • Refusal to shave back hair, if relevant 9) Receiving pharmacologic therapy for IBS that has been started or changed within 30 days of study enrollment 10) Non-English speaking 11) Unable to provide written informed consent 12) Have a history of gastrointestinal disease including celiac disease, cirrhosis, gastrointestinal malignancy, inflammatory bowel disease, or diverticulitis, active within the prior 2 years. 13) Have a history of gastrointestinal surgery (except appendectomy and cholecystectomy or gallbladder removal >6 months ago) 14) Have poorly controlled psychiatric disease such as severe depression (with or without suicidal ideation), severe anxiety, schizophrenia, dementia 15) Have excessive alcohol intake (more than 1 drink per day for females and 2 drinks per day for males) 16) Use illicit substances 17) Use high-dose opiates 18) Severe allergy to adhesive tape

Treatment and study plan

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

Primary outcomes

  1. Post-Avoidance Diet Relative IBS Symptom Global Assessment

    Time frame: Questionnaire to be completed promptly after completion of 16 week avoidance diet.

    Participant global assessment of IBS symptoms compared to the three months prior to entering study, assessed by a post-avoidance diet questionnaire. The assessment is a 7 point Likert scale with 1=substantially improved; 2=moderately improved; 3=slightly improved; 4=no change; 5=slightly worse; 6=moderately worse; 7=substantially worse

Study contacts

Contact information is provided by the study sponsor or research team.

Michael B Stierstorfer, MD

CONTACT

[email protected]

215-699-1929

Sally Iles, BSN, MBA

CONTACT

[email protected]

617-922-1130

Sponsors and collaborators

Lead sponsor

IBS-80, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 1, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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