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True avoidance diet 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.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and questionnaire to be completed promptly after completion of 16 week avoidance diet. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

IBS-80, LLCLead Sponsor

Michael B Stierstorfer, MDPrincipal InvestigatorNorth Wales Dermatology, PLLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are involved in the execution of this study?

"Recruitment for this clinical trial is ongoing at sites like Modern Dermatology NYC in New york, Allergy & Asthma Care of New York in Marlborough, and North Wales Dermatology, PLLC in North Wales. In addition to these locations, there are 6 other centers participating in patient recruitment."

Answered by AI

Are there any openings for new participants in this ongoing clinical trial?

"Yes, information on clinicaltrials.gov indicates that this trial is currently seeking participants. The trial was initially listed on August 15, 2023, and the most recent update was made on February 25, 2024. This study aims to enroll 250 patients across six different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IBS Skin Patch Test Food Allergy Study

2023. "IBS Skin Patch Test Food Allergy Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06288672.

All > Irritable Bowel Syndrome > Food Allergy