RECRUITING

IBS Skin Patch Test Food Allergy Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-15
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06288672

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Under age 18 years
  2. 2. Pregnant
  3. 3. Severe rash
  4. 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. 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. 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

Contacts and Locations

Study Contact

Michael B Stierstorfer, MD
CONTACT
215-699-1929
mbstierstorfer@gmail.com
Sally Iles, BSN, MBA
CONTACT
617-922-1130
sallyiles3@gmail.com

Principal Investigator

Michael B Stierstorfer, MD
PRINCIPAL_INVESTIGATOR
North Wales Dermatology, PLLC

Study Locations (Sites)

Adult and Pediatric Dermatology
Marlborough, Massachusetts, 01752
United States
Adult and Pediatric Dermatology
Westford, Massachusetts, 01886
United States
Allergy & Asthma Care of New York
New York, New York, 10016
United States
Modern Dermatology NYC
New York, New York, 10016
United States
North Wales Dermatology, PLLC
North Wales, Pennsylvania, 19454
United States
Shepherd Allergy
Barboursville, West Virginia, 25504
United States

Collaborators and Investigators

Sponsor: IBS-80, LLC

  • Michael B Stierstorfer, MD, PRINCIPAL_INVESTIGATOR, North Wales Dermatology, PLLC

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 Registration Dates

Study Start Date2023-08-15
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-08-15
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • irritable bowel syndrome
  • IBS
  • FODMAP
  • low FODMAP
  • IBS diet
  • IBS food allergy
  • IBS solution
  • IBS treatment
  • IBS foods
  • low FODMAP diet
  • IBS evaluation
  • irritable bowel syndrome treatment
  • irritable bowel syndrome management
  • IBS cause
  • irritable bowel syndrome pathogenesis
  • irritable bowel syndrome evaluation
  • IBS pathogenesis

Additional Relevant MeSH Terms

  • Irritable Bowel Syndrome