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

What this Trial Is About

Researchers are investigating a targeted elimination diet for patients with Irritable Bowel Syndrome (IBS) to understand how certain nutrients trigger acute mucosal reactions in the gut. The study aims to assess how symptoms respond when trigger nutrients, identified through confocal laser endomicroscopy (CLE), are removed from the diet compared to a sham diet. This trial hopes to clarify the mechanisms behind these acute mucosal reactions and their impact on IBS symptoms. Participants will first undergo a baseline evaluation including CLE while exposed to various nutrients. Those showing an acute mucosal reaction to a specific nutrient will follow a diet excluding that trigger nutrient and a sham diet excluding a nutrient without a reaction in a randomized, blinded crossover design for 4 weeks each. For participants without identified trigger nutrients, wheat and soy will be excluded in a similar crossover fashion. The study uses quadruple masking and randomized allocation to compare these dietary interventions. Throughout the study, researchers will monitor symptom response after 4 weeks on each diet. They will also measure baseline and post-intervention gut permeability and mucosal immune cell composition. Participants will complete questionnaires and provide consent, and women of child-bearing potential will follow strict birth control measures. Safety monitoring includes excluding participants with certain allergies, recent medication use, or other gastrointestinal conditions. The total study duration includes baseline assessments and two 4-week diet periods, with follow-up assessments at the end of each intervention.

ConfocAl endomicroSCopy bAsed Diet Trial in IBS