Investigating Immune Reactions to Food in IBS Patients

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

This study is trying to see how certain foods affect the immune system in people with Irritable Bowel Syndrome (IBS), especially those with a specific infection, to find out which foods might be causing their symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sahlgrenska University Hospital (Academic / other)
• Locations: 1 site (Gothenburg)
• Trial ID: NCT06413004 on ClinicalTrials.gov

What this trial studies

This study aims to explore local immune responses in the gastrointestinal tract of patients with Irritable Bowel Syndrome (IBS) to various food antigens, particularly focusing on those with and without Brachyspira infection. Utilizing advanced imaging techniques such as confocal laser endomicroscopy (CLE) and colonoscopic antigen provocation tests (COLAP), the researchers will identify specific food items that trigger immune reactions. Participants will undergo a series of examinations, including questionnaires, blood tests, and sigmoidoscopy, to assess their symptoms and dietary impacts. The study will also involve dietary modifications based on the findings from these tests.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with IBS who experience gastrointestinal symptoms related to food intake.

Not a fit: Patients with significant organic gastrointestinal diseases or systemic food allergies are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for IBS patients by identifying specific food sensitivities and tailoring dietary recommendations.

How similar studies have performed: While the specific approach of this study is novel, similar studies have shown promise in understanding food sensitivities in IBS patients.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Female patients who are pregnant or lactating (females of fertile age are requested to use a safe contraceptive) at the time of inclusion.
* Patients who use or used new medications that affect the GI functioning within 1 month before the start of the study.

Where this trial is running

Gothenburg

• Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)

Study contacts

• Study coordinator: Magnus Simrén, MD PhD

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