Actively Recruiting
Targeted Elimination Diet in Functional Dyspepsia Patients Using Confocal Laser Endomicroscopy
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
65
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating functional dyspepsia (FD) by studying how patients react to specific nutrients using confocal laser endomicroscopy (CLE). The goal is to understand the acute mucosal reactions triggered by certain nutrients and to assess how avoiding these triggers affects symptoms. This trial aims to clarify the mechanisms behind these reactions and evaluate the impact of targeted diets on symptom relief. Participants will undergo baseline evaluation with CLE while being exposed to nutrients. Those showing an acute mucosal reaction will follow a diet excluding the identified trigger nutrient, while others will follow a sham diet excluding a nutrient without reaction. Patients without identified triggers will participate in a randomized, blinded crossover trial excluding wheat and soy in turn. Each dietary intervention lasts for four weeks. During the study, participants will be monitored for symptom response after each diet period. Assessments include measuring responder rates to the targeted versus sham diet, and examining duodenal electrical resistance, permeability, and immune cell composition at baseline and after dietary interventions. The study includes a follow-up period and requires participants to complete questionnaires and comply with study protocols over the entire intervention timeline.
CONDITIONS
Brief 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
- Diagnosed with functional dyspepsia (PDS, EPS, or overlap) according to Rome IV criteria
- Provide written informed consent to participate
- Women of child-bearing potential agree to use highly effective birth control during the trial
- Women of non-childbearing 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 (except cholecystectomy or uncomplicated appendectomy)
- Symptoms mainly linked to irritable bowel syndrome or gastro-esophageal reflux disease
- IgE-mediated food allergies confirmed by immunocaps blood tests
- Known organic gastrointestinal diseases
- Current use of NSAIDs, proton-pump inhibitors, histamine-receptor antagonists, mast cell stabilizers, corticosteroids, opioids (must be stopped at least 2 weeks prior)
- 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks per diet intervention
Participants follow different dietary interventions excluding certain nutrients in a blinded crossover fashion to evaluate their effect on functional dyspepsia.
1 baseline visit and 1 follow-up visit per diet intervention
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
J
Jolien Schol, MD
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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