Actively Recruiting
PEA in Functional Dyspepsia
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01
100
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PEA in Functional Dyspepsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with functional dyspepsia diagnosed by Rome IV criteria
- Age between 18 and 70 years
- Male or female subjects
- Able to understand the study, complete questionnaires, and comply with study requirements
- Provide witnessed written informed consent before any study procedures
- Women of child-bearing potential must use highly effective birth control during the trial
- Women of non-childbearing potential may participate if surgically sterile or postmenopausal for at least 2 years
You will not qualify if you...
- History of gastrointestinal surgery other than appendectomy and cholecystectomy
- Presence of organic gastrointestinal disease
- Major psychiatric disorders such as major depression
- Diagnosis of coeliac disease, lupus, scleroderma, or other systemic autoimmune diseases
- Eosinophilic esophagitis
- Diabetes mellitus
- Active Helicobacter pylori infection or less than 6 months after eradication
- Predominant irritable bowel syndrome based on Rome IV questionnaire
- Predominant gastroesophageal reflux disease based on Rome IV questionnaire
- Taking prohibited medications
- Pregnant or lactating females
- Unable to understand or comply with the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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