The goal of this placebo controlled randomized double blind interventional study is to assess the effect of palmitoylethanolamide supplementation in patients with functional dyspepsia The main questions it aims to answer are: * The efficacy of PEA on functional dyspepsia symptoms measured using the LPDS questionnaire * The effect of PEA on duodenal mucosal permeability. Participants will receive an 8-week during treatment with PEA 3x400 mg per day or placebo 3 times per day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
8-week treatment 3x400 mg per day
KU Leuven
Leuven, Vlaams-Brabant, Belgium
RECRUITINGEffect (change) on the Leuven-postprandial distress scale (LPDS) (0-15), higher score indicating more symptoms)
Validated questionnaire for measurement of dyspeptic symptoms in functional dyspepsia
Time frame: Comparison after 8 weeks of treatment with placebo or PEA
Effect of PEA supplementation on duodenal permeability
Duodenal biopsies in Ussing chambers (measurement of mucosal permeability)
Time frame: Comparison after 8 weeks of treatment with placebo or PEA
Effect of PEA supplementation on duodenal inflammation
Counting of mast-cells and eosinophils
Time frame: Comparison after 8 weeks of treatment with placebo or PEA
Effect of PEA on gastric emptying
Assessed by gastric emptying breath test
Time frame: Comparison after 8 weeks of treatment with placebo or PEA
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