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
Qualifiers
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
Treatments tested in this trial
- Palmitoylethanolamide
Treatment groups
100 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov