RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: True avoidance diet 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.

Official registry: https://clinicaltrials.gov/study/NCT06288672 · IBS-80, LLC · enrollment listed as 250

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are True avoidance diet, or Sham avoidance diet. The registry lists allocation as randomized. 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.

They plan to enroll about 250 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

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

Interventions: True avoidance diet, Sham avoidance diet

Primary outcome (registry wording): Post-Avoidance Diet Relative IBS Symptom Global Assessment

Who it is for (from inclusion criteria)

Ages 18 Years to any
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

Who the registry excludes

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
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

Public study contact (from the registry)

Michael B Stierstorfer, MD

215-699-1929

mbstierstorfer@gmail.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

North Wales Dermatology, PLLC — North Wales, Pennsylvania (recruiting)
University of Pennsylvania Dermatology — Philadelphia, Pennsylvania (recruiting)

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FAQ about this NCT record

Is NCT06288672 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06288672?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06288672?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary