NCT05666154

Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

After a thorough baseline evaluation, functional dyspepsia (FD) patients will be exposed to nutrients while undergoing confocal laser endomicroscopy (CLE). Patients presenting an acute mucosal reaction upon nutrient exposure will be instructed to exclude their respective trigger nutrient or a nutrient without mucosal reaction (=sham diet) from their diet for 4 weeks in a randomized, blinded crossover fashion. The aim of the trial is to assess the symptomatic response to the targeted diet and further elucidate mechanisms underlying the acute mucosal reactions observed in CLE upon nutrient exposure.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
OTHER	Real diet	Diet excluding either trigger nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger)
OTHER	Sham diet	Diet excluding either sham nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger) or wheat and soy in a blinded crossover fashion (CLE negative individuals without identified trigger)
OTHER	Wheat exclusion diet	Diet excluding wheat in a blinded crossover fashion (CLE negative individuals without identified trigger)
OTHER	Soy exclusion diet	Diet excluding soy in a blinded crossover fashion (CLE negative individuals without identified trigger)

Timeline

• Start date: 2021-12-05
• Primary completion: 2025-07-31
• Completion: 2025-08-31
• First posted: 2022-12-27
• Last updated: 2024-07-03

Locations

1 site across 1 country: Belgium