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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:
Participants will receive an 8-week during treatment with PEA 3x400 mg per day or placebo 3 times per day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palmitoylethanolamide | Dietary Supplement | 8-week treatment 3x400 mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Effect of PEA supplementation on duodenal inflammation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33065341 | Background | 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. |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C005958 | palmidrol |
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Double blind, placebo controlled study
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Counting of mast-cells and eosinophils
| Comparison after 8 weeks of treatment with placebo or PEA |
| Effect of PEA on gastric emptying | Assessed by gastric emptying breath test | Comparison after 8 weeks of treatment with placebo or PEA |