Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia
Targeted Elimination Diet in FD Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy
Universitaire Ziekenhuizen KU Leuven
65 participants
Dec 5, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria9
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Diet excluding either trigger nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger)
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)
Diet excluding wheat in a blinded crossover fashion (CLE negative individuals without identified trigger)
Diet excluding soy in a blinded crossover fashion (CLE negative individuals without identified trigger)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05666154