UZ Leuven
Leuven, 3000, Belgium
Location status: Recruiting
NCT Number: NCT05666154
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Leuven, 3000, Belgium
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: After 4 weeks of dietary intervention
Response defined by an improvement of minimum 0.5 points on the LPDS scale
Time frame: At baseline
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
Time frame: At baseline
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
Time frame: Baseline and after 4 weeks of diet
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
Time frame: Baseline and after 4 weeks of diet
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
Time frame: Baseline
Differences in baseline mucosal mast-cell and eosinophil counts between CLE positive and negative patients
Contact information is provided by the study sponsor or research team.
Universitaire Ziekenhuizen KU Leuven
Other
Targeted Elimination Diet in FD Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy
Acronym: CLEFD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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