Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)
Key facts
- Where
- Gothenburg, SwedenSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06413004, who can take part
Where in Sweden
- Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University HospitalGothenburg, SwedenContact: MagTarmlab ., .Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Magnus Simrén
- Trial code
- NCT06413004
- Record updated
- 29 June 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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 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; Patients who use or used new medications that affect the GI functioning within 1 month before the start of the study; 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; Female patients who are pregnant or lactating (females of fertile age are requested to use a safe contraceptive) at the time of inclusion.