Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia

Not Applicable

Recruiting

• Conditions: Functional Dyspepsia
• Interventions: Other: Real diet; Other: Soy exclusion diet; Other: Sham diet; Other: Wheat exclusion diet

• Registration Number: NCT05666154
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-05
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-07-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Age 18-70 y/o (70 years included)
• Male or female subjects
• FD (PDS, EPS or overlap) according to Rome IV criteria
• 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 irritable bowel syndrome or gastro-esophageal reflux disease
• IgE-mediated food allergies identified by immunocaps blood tests
• Known underlying organic gastrointestinal disease
• Current 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 or Propofol
• Known celiac disease
• Following a diet, interfering with the study diet in opinion to the investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Real diet	Real diet	Diet excluding the trigger nutrient identified by an acute mucosal reaction in CLE
Soy exclusion diet	Soy exclusion diet	In patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy.
Sham diet	Sham diet	Diet excluding a sham nutrient without acute mucosal reaction in CLE
Wheat exclusion diet	Wheat exclusion diet	In patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy.

Primary Outcome Measures

Name	Time	Method
Responder rates in targeted diet vs sham diet	After 4 weeks of dietary intervention	Response defined by an improvement of minimum 0.5 points on the LPDS scale

Secondary Outcome Measures

Name	Time	Method
Baseline duodenal transepithelial electrical resistance between groups	At baseline	Differences in baseline permeability measures (TEER and flux, measured with ussing chambers on duodenal biopsies) between CLE positive and negative patients and healthy volunteers using Ussing chambers
Baseline duodenal flux of horse-radish peroxidase between groups	At baseline	Differences in baseline permeability measures (flux, measured with ussing chambers on duodenal biopsies) between CLE positive and negative patients and healthy volunteers using Ussing chambers
Evolution of duodenal flux of horse-radish peroxidase between dietary interventions	Baseline and after 4 weeks of diet	Differences in permeability measures (HRP flux, measured with ussing chambers on duodenal biopsies) between dietary interventions (i.e. verum, sham, wheat and soy) during the dietary interventions using urinary Lactulose/Mannitol/Sucralose ratio
Evolution of duodenal transepithelial electrical resistance between dietary interventions	Baseline and after 4 weeks of diet	Differences in permeability measures (TEER, measured with ussing chambers on duodenal biopsies) between dietary interventions (i.e. verum, sham, wheat and soy) during the dietary interventions using urinary Lactulose/Mannitol/Sucralose ratio
Baseline mucosal immune cell composition between groups	Baseline	Differences in baseline mucosal mast-cell and eosinophil counts between CLE positive and negative patients

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium