Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2021-11-29
2025-03-01
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Palmitoylethanolamide
8-week treatment 3x400 mg per day
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
Palmitoylethanolamide
8-week treatment 3x400 mg per day
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
Palmitoylethanolamide
8-week treatment 3x400 mg per day
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
Palmitoylethanolamide
8-week treatment 3x400 mg per day
Interventions
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Palmitoylethanolamide
8-week treatment 3x400 mg per day
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Locations
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KU Leuven
Leuven, Vlaams-Brabant, Belgium
Countries
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Facility Contacts
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References
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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.
Other Identifiers
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S65406
Identifier Type: -
Identifier Source: org_study_id
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