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Recruiting NCT06413004

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

Trial Parameters

Condition Irritable Bowel Syndrome
Sponsor Magnus Simrén
Study Type INTERVENTIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2022-08-03
Completion 2027-01-01
Interventions
Elimination and re-introduction of CLE or COLAP positive food item(s)

Brief Summary

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. During this study, the investigators will perform either confocal laser endomiscroscopy (CLE) or colonoscopic antigen provocation test (COLAP) to test to which food items the participants react to. Furthermore, the investigators will perform rectal barostat examination and a sigmoidoscopy without laxatives. The investigators will collect biological samples and the participants will complete several questionnaires.

Eligibility Criteria

Inclusion Criteria: * Patients with IBS diagnosis according to their treating physician (ROME IV). * Association between intake of food and GI symptoms. * Witnessed written informed consent prior to any study procedures. * Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements. Exclusion Criteria: * Patients with relevant concurrent organic GI disease (inflammatory bowel disease, abdominal cancer), or a major disease such as diabetes, uncontrolled thyroid disease, heart disease, kidney disease, liver disease, and active malignant disease (not those that were in remission at least 5 years). * 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 judgem

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