NCT06413004 Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)
| NCT ID | NCT06413004 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Magnus Simrén |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-08-03 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2022-08-03 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06413004 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06413004 currently recruiting?
Yes, NCT06413004 is actively recruiting participants. Contact the research team at magnus.simren@medicine.gu.se for enrollment information.
Where is the NCT06413004 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT06413004 clinical trial?
NCT06413004 is sponsored by Magnus Simrén. The trial plans to enroll 200 participants.