An interventional study of Real diet and Sham diet in Functional Dyspepsia, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment
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.
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 959 studies on the registry; 263 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diet excluding the trigger nutrient identified by an acute mucosal reaction in CLE
Other: Real diet
Diet excluding a sham nutrient without acute mucosal reaction in CLE
Other: Sham diet
In patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy.
Other: Wheat exclusion diet
In patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy.
Other: Soy exclusion diet
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)
Responder rates in targeted diet vs sham diet
Response defined by an improvement of minimum 0.5 points on the LPDS scale
Time frame: After 4 weeks of dietary intervention
Baseline duodenal transepithelial electrical resistance between groups
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
Baseline duodenal flux of horse-radish peroxidase between groups
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: At baseline
Evolution of duodenal flux of horse-radish peroxidase between dietary interventions
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
Evolution of duodenal transepithelial electrical resistance between dietary interventions
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 and after 4 weeks of diet
Baseline mucosal immune cell composition between groups
Differences in baseline mucosal mast-cell and eosinophil counts between CLE positive and negative patients
Time frame: Baseline
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universitaire Ziekenhuizen KU Leuven →