Actively Recruiting
Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
65
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-70 years (70 years included)
- Male or female subjects
- Functional dyspepsia (PDS, EPS, or overlap) according to Rome IV criteria
- Provide written informed consent to participate
- Women of child-bearing potential must use highly effective birth control during the trial
- Women not of child-bearing potential may be included if surgically sterile or postmenopausal for at least 2 years
- Able to understand the study and comply with study requirements
You will not qualify if you...
- Pregnant or breastfeeding women
- History of major gastrointestinal surgery (cholecystectomy and uncomplicated appendectomy allowed)
- Symptoms mainly related to irritable bowel syndrome or gastro-esophageal reflux disease
- IgE-mediated food allergies confirmed by immunocaps blood tests
- Known organic gastrointestinal disease
- Current use of NSAIDs, proton-pump inhibitors, systemic histamine-receptor antagonists, mast cell stabilizers, corticosteroids, or opioids (must stop at least 2 weeks before)
- Use of antibiotics in the past 6 weeks
- Allergy to Fluorescein or Propofol
- Known celiac disease
- Following a diet that interferes with the study diet according to investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
J
Jolien Schol, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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