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PEA in Functional Dyspepsia

Primary Purpose

Dyspepsia and Other Specified Disorders of Function of Stomach

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Palmitoylethanolamide
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia and Other Specified Disorders of Function of Stomach

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • KU LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

PEA + participant ON-PPI

Placebo + Participant ON-PPI

PEA + participant OFF-PPI

Placebo + participant OFF-PPI

Arm Description

Patiënts that on baseline take daily PPI treatment are randomized in the ON-PPI PEA arm or ON-PPI placebo arm

Patiënts that on baseline take daily PPI treatment are randomized in the ON-PPI PEA arm or ON-PPI placebo arm

Patiënts that do not take PPI at baseline are randomized in the OFF-PPI PEA arm or OFF-PPI placebo arm

Patiënts that do not take PPI at baseline are randomized in the OFF-PPI PEA arm or OFF-PPI placebo arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect of PEA supplementation on duodenal permeability
Duodenal biopsies in Ussing chambers (measurement of mucosal permeability)
Effect of PEA supplementation on duodenal inflammation
Counting of mast-cells and eosinophils
Effect of PEA on gastric emptying
Assessed by gastric emptying breath test

Full Information

First Posted
March 6, 2023
Last Updated
May 23, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT05877781
Brief Title
PEA in Functional Dyspepsia
Official Title
THE EFFECT OF DIETARY SUPPLEMENTATION WITH PALMITOYLETHANOLAMIDE ON GASTROINTESTINAL SYMPTOMS IN FUNCTIONAL DYSPEPSIA PATIENTS.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia and Other Specified Disorders of Function of Stomach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind, placebo controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEA + participant ON-PPI
Arm Type
Active Comparator
Arm Description
Patiënts that on baseline take daily PPI treatment are randomized in the ON-PPI PEA arm or ON-PPI placebo arm
Arm Title
Placebo + Participant ON-PPI
Arm Type
Placebo Comparator
Arm Description
Patiënts that on baseline take daily PPI treatment are randomized in the ON-PPI PEA arm or ON-PPI placebo arm
Arm Title
PEA + participant OFF-PPI
Arm Type
Active Comparator
Arm Description
Patiënts that do not take PPI at baseline are randomized in the OFF-PPI PEA arm or OFF-PPI placebo arm
Arm Title
Placebo + participant OFF-PPI
Arm Type
Placebo Comparator
Arm Description
Patiënts that do not take PPI at baseline are randomized in the OFF-PPI PEA arm or OFF-PPI placebo arm
Intervention Type
Dietary Supplement
Intervention Name(s)
Palmitoylethanolamide
Intervention Description
8-week treatment 3x400 mg per day
Primary Outcome Measure Information:
Title
Effect (change) on the Leuven-postprandial distress scale (LPDS) (0-15), higher score indicating more symptoms)
Description
Validated questionnaire for measurement of dyspeptic symptoms in functional dyspepsia
Time Frame
Comparison after 8 weeks of treatment with placebo or PEA
Secondary Outcome Measure Information:
Title
Effect of PEA supplementation on duodenal permeability
Description
Duodenal biopsies in Ussing chambers (measurement of mucosal permeability)
Time Frame
Comparison after 8 weeks of treatment with placebo or PEA
Title
Effect of PEA supplementation on duodenal inflammation
Description
Counting of mast-cells and eosinophils
Time Frame
Comparison after 8 weeks of treatment with placebo or PEA
Title
Effect of PEA on gastric emptying
Description
Assessed by gastric emptying breath test
Time Frame
Comparison after 8 weeks of treatment with placebo or PEA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
KU Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Tack, PhD, MD
Phone
0032163332211
Email
jan.tack@kuleuven.be
First Name & Middle Initial & Last Name & Degree
Bert Broeders, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33065341
Citation
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.
Results Reference
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PEA in Functional Dyspepsia

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