Diet modification based on endomicroscopy in IBS patients

Targeted Elimination Diet in IBS Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy

This study tests whether changing the diet of people with Irritable Bowel Syndrome can help reduce their symptoms by identifying and avoiding specific trigger foods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Locations: 1 site (Leuven)
• Trial ID: NCT05097872 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effects of specific dietary changes on patients with Irritable Bowel Syndrome (IBS) using confocal laser endomicroscopy (CLE) to identify trigger nutrients. After a baseline assessment, patients will be exposed to various nutrients while undergoing CLE to observe any acute mucosal reactions. Those who react will follow a randomized, blinded crossover diet excluding the trigger nutrient for four weeks. The study aims to assess symptom relief and understand the mechanisms behind these mucosal reactions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with moderate to severe IBS-D or IBS-M symptoms as defined by the Rome IV criteria.

Not a fit: Patients with IBS-C or those with mild symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to personalized dietary recommendations that significantly improve the quality of life for IBS patients.

How similar studies have performed: While dietary interventions in IBS have been explored, this specific approach using CLE to identify triggers is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Age 18-70 y/o (70 years included)
* Male or female subjects
* IBS-D and IBS-M (i.e. IBS-non-C) according to Rome IV criteria
* Moderate to severe symptom severity as defined by the Irritable bowel syndrome severity scoring system (IBS-SSS) (i.e. IBS-SSS \>175 points)
* Provide written informed consent to participate in the study
* Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
* Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements.

Exclusion Criteria:

* \- Pregnant or breastfeeding women
* History of major surgery of the gastrointestinal tract (cholecystectomy and uncomplicated appendectomy are allowed)
* Symptoms predominantly associated with functional dyspepsia or gastro-esophageal reflux disease
* Immunoglobuline E (IgE)-mediated food allergies identified by immunocap blood tests or skin prick testing
* Known underlying organic gastrointestinal disease
* Current or recent use of NSAIDs, proton-pump inhibitors, systemic histamine-receptor antagonists, mast cell stabilizers, corticosteroids, opioids (need to be stopped at least 2 weeks). Use of antibiotics in the past 6 weeks.
* Allergy to Fluorescein, Xylocaine or Propofol
* Known celiac disease
* Following a diet interfering with the study diet in opinion of the investigator

Where this trial is running

Leuven

• UZ Leuven — Leuven, Belgium (Recruiting)

Study contacts

• Study coordinator: Lukas M Balsiger, MD

Conditions Irritable Bowel Syndrome