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

Recruiting now · Not applicable

Conditions studied: Irritable Bowel Syndrome, Food Sensitivity

In brief

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 confocal laser endomiscroscopy (CLE) and/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.

Key facts

Study ID

NCT06413004

Run by

Magnus Simrén

People needed

200

Starts

2022-08-03

Expected to finish

2027-12-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 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.

Where it is running

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

Full record on ClinicalTrials.gov

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