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Skin Patch Test for Irritable Bowel Syndrome
N/A
Recruiting
Led By Michael B Stierstorfer, MD
Research Sponsored by IBS-80, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up questionnaire to be completed promptly after completion of 16 week avoidance diet.
Summary
This trial tests people with IBS for food allergies using skin patches instead of needles. Participants are tested for reactions to 80 different foods and food additives over 3 office visits in a 4-
Who is the study for?
This trial is for individuals with Irritable Bowel Syndrome (IBS) who are interested in finding out if food allergies might be contributing to their symptoms. Participants will undergo skin patch testing for various foods and additives, but they must be able to visit the office three times over a few days.
What is being tested?
The study tests whether avoiding certain foods after identifying potential allergies can improve IBS symptoms. Participants follow either a 'true' avoidance diet excluding identified allergens or a 'sham' diet where no allergens are avoided, without knowing which one they're on.
What are the potential side effects?
There may be minimal side effects from the skin patch test such as temporary redness or irritation at the site of application. The dietary changes could potentially lead to nutritional imbalances if not properly managed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ questionnaire to be completed promptly after completion of 16 week avoidance diet.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~questionnaire to be completed promptly after completion of 16 week avoidance diet.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post-Avoidance Diet Relative IBS Symptom Global Assessment
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: True avoidance dietActive Control1 Intervention
Food patch test-directed avoidance diet for 16 weeks where participant avoids avoid eating the food(s) to which they are allergic
Group II: Sham avoidance dietPlacebo Group1 Intervention
Avoidance diet for 16 weeks of randomly selected foods to which the patch testing did not show an allergy
Find a Location
Who is running the clinical trial?
IBS-80, LLCLead Sponsor
Michael B Stierstorfer, MDPrincipal InvestigatorNorth Wales Dermatology, PLLC