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PEA in Functional Dyspepsia

Sponsor
Universitaire Ziekenhuizen KU Leuven (Other)
Overall Status
Recruiting
CT.gov ID
NCT05877781
Collaborator
(none)
100
Enrollment
1
Location
4
Arms
27
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Palmitoylethanolamide
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double blind, placebo controlled studyDouble blind, placebo controlled study
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
THE EFFECT OF DIETARY SUPPLEMENTATION WITH PALMITOYLETHANOLAMIDE ON GASTROINTESTINAL SYMPTOMS IN FUNCTIONAL DYSPEPSIA PATIENTS.
Actual Study Start Date :
Nov 29, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. Effect of PEA supplementation on duodenal inflammation [Comparison after 8 weeks of treatment with placebo or PEA]

    Counting of mast-cells and eosinophils

  3. Effect of PEA on gastric emptying [Comparison after 8 weeks of treatment with placebo or PEA]

    Assessed by gastric emptying breath test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 KU Leuven Leuven Vlaams-Brabant Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier:
NCT05877781
Other Study ID Numbers:
  • S65406
First Posted:
May 26, 2023
Last Update Posted:
May 26, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dyspepsia
Palmidrol

Study Results

No Results Posted as of May 26, 2023