PEA in Functional Dyspepsia
Not Applicable
Recruiting
- Conditions
- Dyspepsia and Other Specified Disorders of Function of Stomach
- Interventions
- Dietary Supplement: Palmitoylethanolamide
- Registration Number
- NCT05877781
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- 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.
- Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements.
- Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
Exclusion Criteria
- 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.
- Patients with eosinophilic esophagitis
- Presence of diabetes mellitus
- Active H. Pylori infection or < 6 months after eradication
- Predominant IBS (based on the Rome IV questionnaire)
- Predominant GERD (based on the Rome IV questionnaire)
- Patients taking prohibited medication
- Females who are pregnant or lactating
- Patients not capable to understand or be compliant with the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEA + participant OFF-PPI Palmitoylethanolamide Patiënts that do not take PPI at baseline are randomized in the OFF-PPI PEA arm or OFF-PPI placebo arm PEA + participant ON-PPI Palmitoylethanolamide Patiënts that on baseline take daily PPI treatment are randomized in the ON-PPI PEA arm or ON-PPI placebo arm Placebo + Participant ON-PPI Palmitoylethanolamide Patiënts that on baseline take daily PPI treatment are randomized in the ON-PPI PEA arm or ON-PPI placebo arm Placebo + participant OFF-PPI Palmitoylethanolamide Patiënts that do not take PPI at baseline are randomized in the OFF-PPI PEA arm or OFF-PPI placebo arm
- Primary Outcome Measures
Name Time Method Effect (change) on the Leuven-postprandial distress scale (LPDS) (0-15), higher score indicating more symptoms) Comparison after 8 weeks of treatment with placebo or PEA Validated questionnaire for measurement of dyspeptic symptoms in functional dyspepsia
- Secondary Outcome Measures
Name Time Method Effect of PEA supplementation on duodenal permeability Comparison after 8 weeks of treatment with placebo or PEA Duodenal biopsies in Ussing chambers (measurement of mucosal permeability)
Effect of PEA on gastric emptying Comparison after 8 weeks of treatment with placebo or PEA Assessed by gastric emptying breath test
Effect of PEA supplementation on duodenal inflammation Comparison after 8 weeks of treatment with placebo or PEA Counting of mast-cells and eosinophils
Trial Locations
- Locations (1)
KU Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium