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RECRUITING
NCT05666154
NA

Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2021-12-05

Completion Date

2025-08-31

Last Updated

2024-07-03

Healthy Volunteers

Yes

Interventions

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)

Locations (1)

UZ Leuven

Leuven, Belgium