PEA in Functional Dyspepsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with functional dyspepsia as diagnosed by the Rome IV criteria.
Subjects must provide witnessed written informed consent prior to any study procedures being performed.
Subjects aged 18-70 years old.
Male or female subjects.
Disqualifiers
Presence of a history of gastrointestinal surgery other than appendectomy and cholecystectomy.
Organic gastro-intestinal disease
Major psychiatric disorder such as major depression
Presence of coeliac disease, lupus, scleroderma and other systemic auto-immune disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Palmitoylethanolamide
Dietary supplement8-week treatment 3x400 mg per day
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: PEA + participant ON-PPIActive comparator 1 intervention
Group B: Placebo + Participant ON-PPIPlacebo comparator 1 intervention
Group C: PEA + participant OFF-PPIActive comparator 1 intervention
Group D: Placebo + participant OFF-PPIPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Effect (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 PEASecondary outcomes
1
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 PEA2
Effect of PEA supplementation on duodenal inflammation
Counting of mast-cells and eosinophils
Time frame
Comparison after 8 weeks of treatment with placebo or PEA3
Effect of PEA on gastric emptying
Assessed by gastric emptying breath test
Time frame
Comparison after 8 weeks of treatment with placebo or PEASponsors and contacts
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Source ClinicalTrials.gov