Actively Recruiting
Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)
Led by Magnus Simrén · Updated on 2024-05-14
200
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with IBS diagnosis according to their treating physician (ROME IV).
- Association between intake of food and GI symptoms.
- Written informed consent given before any study procedures.
- Ability to understand the study, complete questionnaires, and follow study requirements.
You will not qualify if you...
- Presence of significant organic GI diseases (such as inflammatory bowel disease or abdominal cancer) or major illnesses like diabetes, uncontrolled thyroid disease, heart, kidney, liver diseases, or active cancer not in remission for 5 years.
- History of bowel surgery affecting GI motility (except appendectomy or cholecystectomy).
- Systemic food allergy confirmed by blood or skin prick tests.
- History of severe allergic reactions.
- Major confounding conditions like dominant psychiatric disorders, serious depression, or substance abuse within the past 2 years.
- Pregnant or breastfeeding women; women of childbearing age must use safe contraception.
- Use of new medications affecting GI function within 1 month before study start.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Actively Recruiting
Research Team
M
Magnus Simrén, MD PhD
CONTACT
M
MagTarmlab office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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