PEA in Functional Dyspepsia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dyspepsia and Other Specified Disorders of Function of Stomach
• Intervention / Treatment: Dietary supplement: Palmitoylethanolamide

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • KU Leuven
      • Contact: Jan Tack, PhD, MD; Phone Number: 0032163332211; Email: jan.tack@kuleuven.be
      • Sub-Investigator: Bert Broeders, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

General Publications

• Sarnelli G, Pesce M, Seguella L, Lu J, Efficie E, Tack J, Elisa De Palma FD, D'Alessandro A, Esposito G. Impaired Duodenal Palmitoylethanolamide Release Underlies Acid-Induced Mast Cell Activation in Functional Dyspepsia. Cell Mol Gastroenterol Hepatol. 2021;11(3):841-855. doi: 10.1016/j.jcmgh.2020.10.001. Epub 2020 Oct 14.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Palmidrol
• Other Study ID Numbers: S65406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No