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

NCT06413004 | Recruiting

• 1 other identifier: 2022-06370-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome; Food Sensitivity

Keywords

Irritable Bowel Syndrome; Food Sensitivity; Confocal Laser Endomicroscopy; Colonoscopic Antigen Provocation Test

Outcome Measures

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.

  4 weeks after exclusion

Secondary Outcomes (9)

• IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after exclusion (absolute)

  4 weeks after exclusion

• IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after reintroduction (proportion)

  4 weeks after reintroduction

• IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after reintroduction (absolute)

  4 weeks after reintroduction

• GSRS-IBS (the Gastrointestinal Symptom Rating Scale Irritable Bowel Syndrome version) after exclusion

  4 weeks after exclusion

• GSRS-IBS (the Gastrointestinal Symptom Rating Scale Irritable Bowel Syndrome version) after reintroduction

  4 weeks after reintroduction

Study Arms (1)

Positive food item during CLE or COLAP

OTHER

The food item(s) which were positive during CLE (fluorescein leakage and cell shedding) or COLAP (swelling).

Other: Elimination and re-introduction of CLE or COLAP positive food item(s)

Interventions

Elimination and re-introduction of CLE or COLAP positive food item(s) OTHER

Elimination (4 weeks) and re-introduction (4 weeks) of all CLE or COLAP positive food item(s)

Positive food item during CLE or COLAP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Magnus Simrén: lead

Study Sites (1)

Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Food Intolerance

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Magnus Simrén, MD PhD

CONTACT

0046313428107; magnus.simren@medicine.gu.se

MagTarmlab office

CONTACT

0046313428107; magtarmlab.su@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: Unblinded elimination and re-introduction of a positive tested food item, identified during CLE or COLAP

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 14, 2024
• Study Start: August 3, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

SE (1)