Investigating Immune Reactions to Food in IBS Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Magnus Simrén, MD PhD
• Email: magnus.simren@medicine.gu.se
• Phone: 0046313428107

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.