PEA in Functional Dyspepsia

Study Overview
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Brief Summary
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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.

Official Title
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THE EFFECT OF DIETARY SUPPLEMENTATION WITH PALMITOYLETHANOLAMIDE ON GASTROINTESTINAL SYMPTOMS IN FUNCTIONAL DYSPEPSIA PATIENTS.

Conditions
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Dyspepsia and Other Specified Disorders of Function of Stomach

Intervention / Treatment
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* Dietary Supplement: Palmitoylethanolamide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind, placebo controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PEA + participant ON-PPI<br>Patiënts that on baseline take daily PPI treatment are randomized in the ON-PPI PEA arm or ON-PPI placebo arm | Dietary Supplement: Palmitoylethanolamide<br>* 8-week treatment 3x400 mg per day<br>|
| Placebo Comparator: Placebo + Participant ON-PPI<br>Patiënts that on baseline take daily PPI treatment are randomized in the ON-PPI PEA arm or ON-PPI placebo arm | Dietary Supplement: Palmitoylethanolamide<br>* 8-week treatment 3x400 mg per day<br>|
| Active Comparator: PEA + participant OFF-PPI<br>Patiënts that do not take PPI at baseline are randomized in the OFF-PPI PEA arm or OFF-PPI placebo arm | Dietary Supplement: Palmitoylethanolamide<br>* 8-week treatment 3x400 mg per day<br>|
| Placebo Comparator: Placebo + participant OFF-PPI<br>Patiënts that do not take PPI at baseline are randomized in the OFF-PPI PEA arm or OFF-PPI placebo arm | Dietary Supplement: Palmitoylethanolamide<br>* 8-week treatment 3x400 mg per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Comparison after 8 weeks of treatment with placebo or PEA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of PEA supplementation on duodenal permeability | Duodenal biopsies in Ussing chambers (measurement of mucosal permeability) | Comparison after 8 weeks of treatment with placebo or PEA | 
| Effect of PEA supplementation on duodenal inflammation | Counting of mast-cells and eosinophils | Comparison after 8 weeks of treatment with placebo or PEA | 
| Effect of PEA on gastric emptying | Assessed by gastric emptying breath test | Comparison after 8 weeks of treatment with placebo or PEA |