Actively Recruiting
ConfocAl endomicroSCopy bAsed Diet Trial in IBS
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
65
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
After a thorough baseline evaluation, IBS 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 endomicroSCopy bAsed Diet Trial in IBS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-70 years (including 70 years)
- Male or female subjects
- Diagnosis of IBS-D or IBS-M according to Rome IV criteria
- Moderate to severe symptom severity measured by IBS severity scoring system (IBS-SSS >175 points)
- Written informed consent provided
- Women of child-bearing potential must use highly effective birth control throughout the study
- Women not of child-bearing potential must be surgically sterile or postmenopausal for at least 2 years
- Ability to understand the study and comply with requirements
You will not qualify if you...
- Pregnant or breastfeeding women
- History of major gastrointestinal surgery (except cholecystectomy and uncomplicated appendectomy)
- Symptoms mainly caused by functional dyspepsia or gastro-esophageal reflux disease
- IgE-mediated food allergies confirmed by tests
- Known organic gastrointestinal diseases
- Current or recent use of NSAIDs, proton-pump inhibitors, systemic histamine-receptor antagonists, mast cell stabilizers, corticosteroids, opioids (must have stopped at least 2 weeks prior)
- Use of antibiotics in the past 6 weeks
- Allergy to Fluorescein, Xylocaine, or Propofol
- Known celiac disease
- Following a diet considered interfering with the study diet by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
L
Lukas M Balsiger, 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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