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NCT06413004

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

Magnus Simrén·ClinicalTrials.gov·otherRecruiting
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Study focus
Disease/Condition
Irritable Bowel Syndrome,Food Sensitivity
Drug/Device/Intervention
Elimination and re-introduction of CLE or COLAP positive food item(s)
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
Magnus Simrén
Funder
Sahlgrenska University Hospital, Sweden
Location
Gothenburg, Sweden
Timeline & enrollment
Phase
N/A
Start date
Aug 03, 2022
End date
Jan 01, 2027
Enrollment
200 participants
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
Irritable bowel syndromeOther and unspecified irritable bowel syndromeIrritable bowel syndrome with mixed bowel habits [IBS-M]Irritable bowel syndrome with predominant constipation [IBS-C]Irritable bowel syndrome with predominant diarrhoea [IBS-D]
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06413004
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.