Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMagnus Simrén
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Elimination and re-introduction of CLE or COLAP positive food item(s)
Other interventionElimination (4 weeks) and re-introduction (4 weeks) of all CLE or COLAP positive food item(s)
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Positive food item during CLE or COLAPOther 1 intervention
Trial outcomes
Primary outcomes
1
IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after exclusion (proportion).
the proportion of participants with an IBS-SSS reduction of ≥50 points, measured before (visit 4) and after (visit 5) exclusion of the CLE or COLAP positive food item(s) (= responders). IBS-SSS: higher IBS-SSS indicate more severe symptoms. Scores ranging 0-500.
Time frame
4 weeks after exclusionSecondary outcomes
1
IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after exclusion (absolute)
IBS-SSS: absolute change of IBS-SSS, measured before (visit 4) and after (visit 5) EXCLUSION of the CLE or COLAP positive food item(s). Higher IBS-SSS indicate more severe symptoms. Scores ranging 0-500.
Time frame
4 weeks after exclusion2
IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after reintroduction (proportion)
IBS-SSS: the proportion of participants with an IBS-SSS increase of ≥50 points, measured before (visit 5) and after (visit 6) the REINTRODUCTION of the CLE or COLAP positive food item(s): responders vs non-responders (as based on the primary outcome). Higher IBS-SSS indicate more severe symptoms. Scores ranging 0-500.
Time frame
4 weeks after reintroduction3
IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after reintroduction (absolute)
IBS-SSS: the absolute change of IBS-SSS, measured before (visit 5) and after (visit 6) the REINTRODUCTION of the CLE or COLAP positive food item(s): total group and responders vs non-responders (as based on the primary outcome)
Time frame
4 weeks after reintroduction4
GSRS-IBS (the Gastrointestinal Symptom Rating Scale Irritable Bowel Syndrome version) after exclusion
change of total and subscores before (visit 4) and after (visit 5) EXCLUSION of the CLE or COLAP positive food item(s). Total group and responders vs non-responders (as based on the primary outcome). Higher GSRS-IBS indicate more severe symptoms. After calculating of the average scores, those range 1-7.
Time frame
4 weeks after exclusionSponsors and contacts
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Magnus Simrén
Lead sponsor
Sahlgrenska University Hospital
Sponsor institution
Source ClinicalTrials.gov