RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Elimination and re-introduction of CLE or COLAP positive food item(s) for Irritable Bowel Syndrome

The aim of this study is to define local immune responses in the GI tract to food antigens in IBS patients, with and without Brachyspira infection, using advanced imaging. We hypothesize that Brachyspira infection can cause IBS symptoms by inducing loss of oral tolerance to dietary antigens through development of food-specific intestinal immune reactions and subsequent development of visceral hypersensitivity.

Official registry: https://clinicaltrials.gov/study/NCT06413004 · Magnus Simrén · enrollment listed as 200

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 Elimination and re-introduction of CLE or COLAP positive food item(s). The registry lists allocation as na. The aim of this study is to define local immune responses in the GI tract to food antigens in IBS patients, with and without Brachyspira infection, using advanced imaging.

They plan to enroll about 200 people at Gothenburg. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)

Interventions: Elimination and re-introduction of CLE or COLAP positive food item(s)

Primary outcome (registry wording): IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after exclusion (proportion).

Who it is for (from inclusion criteria)

Ages 18 Years to 70 Years
Patients with IBS diagnosis according to their treating physician (ROME IV)
Association between intake of food and GI symptoms

Who the registry excludes

Patients with a history of bowel surgery (not appendectomy or cholecystectomy) that affects GI motility
Patients with systemic food allergy as evidenced by positive allergy tests (blood, prick test)
Clinical history of severe allergic reactions
Patients with concurrent major confounding condition(s) based on the clinician's judgement, e.g. DOMINANT psychiatric disorder, vital depression, alcohol or substance abuse in the last 2 year
Female patients who are pregnant or lactating (females of fertile age are requested to use a safe contraceptive) at the time of inclusion
Patients who use or used new medications that affect the GI functioning within 1 month before the start of the study

Public study contact (from the registry)

Magnus Simrén, MD PhD

0046313428107

magnus.simren@medicine.gu.se

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

Sites listed on ClinicalTrials.gov

1 listed

Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University Hospital — Gothenburg, Sweden (recruiting)

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FAQ about this NCT record

Is NCT06413004 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 NCT06413004?

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 NCT06413004?

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