IBS Skin Patch Test Food Allergy Study

February 25, 2024 updated by: IBS-80, LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Marlborough, Massachusetts, United States, 01752
        • Recruiting
        • Adult and Pediatric Dermatology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christy Williams, MD
      • Westford, Massachusetts, United States, 01886
        • Recruiting
        • Adult and Pediatric Dermatology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christy Williams, MD
    • New York
      • New York, New York, United States, 10016
        • Not yet recruiting
        • Allergy & Asthma Care of New York
        • Contact:
        • Contact:
        • Principal Investigator:
          • Clifford Bassett, MD
      • New York, New York, United States, 10016
        • Recruiting
        • Modern Dermatology NYC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kathryn Frew, MD
    • Pennsylvania
      • North Wales, Pennsylvania, United States, 19454
        • Recruiting
        • North Wales Dermatology, PLLC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael B Stierstorfer, MD
    • West Virginia
      • Barboursville, West Virginia, United States, 25504
        • Recruiting
        • Shepherd Allergy
        • Contact:
        • Contact:
        • Principal Investigator:
          • Meagan Shepherd, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  1. Under age 18 years
  2. Pregnant
  3. Severe rash
  4. 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)
  5. 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
  6. 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

8) 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: 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
Other: Sham avoidance diet
Avoidance diet for 16 weeks of randomly selected foods to which the patch testing did not show an allergy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Questionnaire to be completed promptly after completion of 16 week avoidance diet.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IBS-80, LLC

Investigators

  • Principal Investigator: Michael B Stierstorfer, MD, North Wales Dermatology, PLLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 25, 2024

First Submitted That Met QC Criteria

February 25, 2024

First Posted (Estimated)

March 1, 2024

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on True avoidance diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe