Skin patch testing for food allergies in IBS patients
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Patch Test-Guided Type 4 Food Allergen Dietary Avoidance for Irritable Bowel Syndrome
This study is testing if skin patch tests for food allergies can help people with Irritable Bowel Syndrome better manage their symptoms by identifying foods they should avoid.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ibs-80, LLC Industry-sponsored |
| Locations | 2 sites (North Wales, Pennsylvania and 1 other locations) |
| Trial ID | NCT06288672 on ClinicalTrials.gov |
What this trial studies
This study involves participants with Irritable Bowel Syndrome (IBS) undergoing skin patch testing for 80 different foods and additives to identify potential food allergies. The testing process includes three office visits over a 4 to 5 day period, where patches are applied to the skin and later assessed for allergic reactions. Participants found to have food allergies will follow either a true avoidance diet or a sham avoidance diet for 16 weeks. The goal is to determine the impact of food allergies on IBS symptoms and dietary management.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Irritable Bowel Syndrome who have poorly controlled symptoms.
Not a fit: Patients under 18, pregnant, or those with severe rashes or on immunosuppressive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help IBS patients identify and manage food allergies, potentially improving their symptoms and quality of life.
How similar studies have performed: While the approach of using skin patch testing for food allergies is established, the specific application in IBS is less common, making this study a novel exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Irritable bowel syndrome diagnosed by a primary care provider, gastroenterologist or allergist; or 2. 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
Where this trial is running
North Wales, Pennsylvania and 1 other locations
- North Wales Dermatology, PLLC — North Wales, Pennsylvania, United States (Recruiting)
- Shepherd Allergy — Barboursville, West Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Michael B Stierstorfer, MD — North Wales Dermatology, PLLC
- Study coordinator: Michael B Stierstorfer, MD
- Email: mbstierstorfer@gmail.com
- Phone: 215-699-1929
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.