Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia

NCT ID: NCT05666154

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-05
• Study Completion Date: 2025-08-31

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.

Conditions

Functional Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Real diet

Diet excluding the trigger nutrient identified by an acute mucosal reaction in CLE

Group Type: ACTIVE_COMPARATOR

Real diet

Intervention Type: OTHER

Diet excluding either trigger nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger)

Sham diet

Diet excluding a sham nutrient without acute mucosal reaction in CLE

Group Type: SHAM_COMPARATOR

Sham diet

Intervention Type: OTHER

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)

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.

Group Type: ACTIVE_COMPARATOR

Wheat exclusion diet

Intervention Type: OTHER

Diet excluding wheat in a blinded crossover fashion (CLE negative individuals without identified trigger)

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.

Group Type: ACTIVE_COMPARATOR

Soy exclusion diet

Intervention Type: OTHER

Diet excluding soy in a blinded crossover fashion (CLE negative individuals without identified trigger)

Interventions

Real diet

Diet excluding either trigger nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger)

Intervention Type: 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)

Intervention Type: OTHER

Wheat exclusion diet

Diet excluding wheat in a blinded crossover fashion (CLE negative individuals without identified trigger)

Intervention Type: OTHER

Soy exclusion diet

Diet excluding soy in a blinded crossover fashion (CLE negative individuals without identified trigger)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jolien Schol, MD

Role: CONTACT

jolien.schol@kuleuven.be

+3216345663

Facility Contacts

Jolien Schol, MD

Role: primary

jolien.schol@kuleuven.be

+3216345663

Other Identifiers

S65735

Identifier Type: -

Identifier Source: org_study_id