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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05666154
Other study ID # S65735
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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