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Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia

NCT05666154 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-07-03

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-05
Primary Completion
2025-07-31
Completion
2025-08-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05666154 on ClinicalTrials.gov