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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
Diet excluding either trigger and 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)
UZ Leuven
Leuven, Belgium
RECRUITINGResponder rates in targeted diet vs sham diet
Response defined by an improvement of minimum 50 points in the IBS-SSS.
Time frame: After 4 weeks of dietary intervention
Baseline permeability measures between groups
Differences in baseline permeability measures between CLE positive and negative patients and healthy volunteers using Ussing chambers
Time frame: At baseline
Evolution of permeability measures between dietary interventions
Differences in permeability measures between dietary interventions (i.e. verum, sham, wheat and soy) during the dietary interventions using urinary Lactulose/Mannitol/Sucralose ratio
Time frame: Baseline and end of respective dietary intervention
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
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