PEA in Functional Dyspepsia

Dyspepsia and Other Specified Disorders of Function of Stomach Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05877781
• Other study ID #: S65406
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Dyspepsia and Other Specified Disorders of Function of Stomach

Intervention

Dietary Supplement:
• Palmitoylethanolamide
8-week treatment 3x400 mg per day

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Effect of PEA supplementation on duodenal inflammation	Counting of mast-cells and eosinophils	Comparison after 8 weeks of treatment with placebo or PEA
Secondary	Effect of PEA on gastric emptying	Assessed by gastric emptying breath test	Comparison after 8 weeks of treatment with placebo or PEA