Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia

Functional Dyspepsia Clinical Trial

— CLEFD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05666154
• Other study ID #: S65735
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Jolien Schol, MD
• Phone: +3216345663
• Email: jolien.schol[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: August 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

Other:
• Real diet
Diet excluding either trigger nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger)
• 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)
• Wheat exclusion diet
Diet excluding wheat in a blinded crossover fashion (CLE negative individuals without identified trigger)
• Soy exclusion diet
Diet excluding soy in a blinded crossover fashion (CLE negative individuals without identified trigger)

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder rates in targeted diet vs sham diet	Response defined by an improvement of minimum 0.5 points on the LPDS scale	After 4 weeks of dietary intervention
Secondary	Baseline duodenal transepithelial electrical resistance between groups	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	At baseline
Secondary	Baseline duodenal flux of horse-radish peroxidase between groups	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	At baseline
Secondary	Evolution of duodenal flux of horse-radish peroxidase between dietary interventions	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	Baseline and after 4 weeks of diet
Secondary	Evolution of duodenal transepithelial electrical resistance between dietary interventions	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 and after 4 weeks of diet
Secondary	Baseline mucosal immune cell composition between groups	Differences in baseline mucosal mast-cell and eosinophil counts between CLE positive and negative patients	Baseline