PEA in Functional Dyspepsia

NCT05877781 | Recruiting

• 1 other identifier: S65406
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspepsia and Other Specified Disorders of Function of Stomach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Effect of PEA supplementation on duodenal permeability

  Comparison after 8 weeks of treatment with placebo or PEA

• Effect of PEA supplementation on duodenal inflammation

  Comparison after 8 weeks of treatment with placebo or PEA

• Effect of PEA on gastric emptying

  Comparison after 8 weeks of treatment with placebo or PEA

Study Arms (4)

PEA + participant ON-PPI

ACTIVE COMPARATOR

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

Dietary Supplement: Palmitoylethanolamide

Placebo + Participant ON-PPI

PLACEBO COMPARATOR

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

Dietary Supplement: Palmitoylethanolamide

PEA + participant OFF-PPI

ACTIVE COMPARATOR

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

Dietary Supplement: Palmitoylethanolamide

Placebo + participant OFF-PPI

PLACEBO COMPARATOR

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

Dietary Supplement: Palmitoylethanolamide

Interventions

Palmitoylethanolamide DIETARY_SUPPLEMENT

8-week treatment 3x400 mg per day

PEA + participant OFF-PPI; PEA + participant ON-PPI; Placebo + Participant ON-PPI; Placebo + participant OFF-PPI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related 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.

  PMID: 33065341 BACKGROUND

MeSH Terms

Conditions

Dyspepsia

Interventions

palmidrol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, placebo controlled study

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: May 26, 2023
• Study Start: November 29, 2021
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

BE (1)