Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS) - Trial NCT06413004
Access comprehensive clinical trial information for NCT06413004 through Pure Global AI's free database. This phase not specified trial is sponsored by Magnus Simrén and is currently Recruiting. The study focuses on Irritable Bowel Syndrome,Food Sensitivity. Target enrollment is 200 participants.
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Study Focus
Elimination and re-introduction of CLE or COLAP positive food item(s)
Interventional
other
Sponsor & Location
Magnus Simrén
Sahlgrenska University Hospital, Sweden
Timeline & Enrollment
N/A
Aug 03, 2022
Jan 01, 2027
Primary Outcome
IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after exclusion (proportion).
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06413004
Non-Device Trial