IBS Skin Patch Test Food Allergy Study

Last updated: February 25, 2024
Sponsor: IBS-80, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lactose Intolerance

Gastrointestinal Diseases And Disorders

Colic

Treatment

True avoidance diet

Sham avoidance diet

Clinical Study ID

NCT06288672
1002
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Irritable bowel syndrome diagnosed by a primary care provider, gastroenterologist orallergist; or meeting the Rome IV IBS diagnostic criteria by history and havingsuboptimally or poorly controlled IBS symptoms.

Exclusion

Exclusion Criteria:

  1. Under age 18 years
  2. Pregnant
  3. Severe rash
  4. Receiving any cortisone-containing or any of the following immunosuppressivemedications within two weeks prior to patch testing or plan to do so any time duringthe study: cyclosporine, mycophenylate mofetil, azathioprine, tacrolimus or otherswithin these classes of medications)
  5. Incapable of completing all parts of the 18-week screening period and study, includingfollowing the dietary instructions and completing all text or email questionnaires
  6. Exposure of back to the sun in the 2 weeks prior to patch testing Unable or unwillingto discontinue the low FODMAP diet, if relevant, starting 1 week prior to the studyand for the study duration
  1. Refusal to shave back hair, if relevant 9) Receiving pharmacologic therapy for IBS thathas 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 diseaseincluding celiac disease, cirrhosis, gastrointestinal malignancy, inflammatory boweldisease, or diverticulitis, active within the prior 2 years. 13) Have a history ofgastrointestinal surgery (except appendectomy and cholecystectomy or gallbladder removal >6 months ago) 14) Have poorly controlled psychiatric disease such as severedepression (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 dayfor males) 16) Use illicit substances 17) Use high-dose opiates 18) Severe allergy toadhesive tape

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: True avoidance diet
Phase:
Study Start date:
August 15, 2023
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • Adult and Pediatric Dermatology

    Marlborough, Massachusetts 01752
    United States

    Active - Recruiting

  • Adult and Pediatric Dermatology

    Westford, Massachusetts 01886
    United States

    Active - Recruiting

  • Allergy & Asthma Care of New York

    New York, New York 10016
    United States

    Site Not Available

  • Modern Dermatology NYC

    New York, New York 10016
    United States

    Active - Recruiting

  • North Wales Dermatology, PLLC

    North Wales, Pennsylvania 19454
    United States

    Active - Recruiting

  • Shepherd Allergy

    Barboursville, West Virginia 25504
    United States

    Active - Recruiting

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