Dyspepsia and Other Specified Disorders of Function of StomachNCT05877781
PEA in Functional Dyspepsia
A study testing Palmitoylethanolamide in people with Dyspepsia and Other Specified Disorders of Function of Stomach, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dyspepsia and Other Specified Disorders of Function of Stomach
- What is being tested?
- Palmitoylethanolamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Nov 2021to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
KU Leuven
Leuven, Vlaams-Brabant, 3000
Jan Tack, PhD, MD, 0032163332211, jan.tack@kuleuven.be
Bert Broeders, MD
About this study
Official title: THE EFFECT OF DIETARY SUPPLEMENTATION WITH PALMITOYLETHANOLAMIDE ON GASTROINTESTINAL SYMPTOMS IN FUNCTIONAL DYSPEPSIA PATIENTS.
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.
- Being tested
- Palmitoylethanolamide
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalmitoylethanolamideDietary supplement
8-week treatment 3x400 mg per day
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Palmitoylethanolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Comparison after 8 weeks of treatment with placebo or PEA
Secondary outcomes (3)
Effect of PEA supplementation on duodenal permeability
Duodenal biopsies in Ussing chambers (measurement of mucosal permeability)
Measured: Comparison after 8 weeks of treatment with placebo or PEA
Effect of PEA supplementation on duodenal inflammation
Counting of mast-cells and eosinophils
Measured: Comparison after 8 weeks of treatment with placebo or PEA
Effect of PEA on gastric emptying
Assessed by gastric emptying breath test
Measured: Comparison after 8 weeks of treatment with placebo or PEA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start29 Nov 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dyspepsia and Other Specified Disorders of Function of StomachStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, placebo controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877781
- Sponsor's protocol ID
- S65406
- Status last verified
- Jun 2024
- First submitted
- 6 Mar 2023
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33065341
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF DIETARY SUPPLEMENTATION WITH PALMITOYLETHANOLAMIDE ON GASTROINTESTINAL SYMPTOMS IN FUNCTIONAL DYSPEPSIA PATIENTS.
- ClinicalTrials.gov ID
- NCT05877781
- Acronym / sponsor ID
- S65406
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double blind, placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| PEA + participant ON-PPI | Active comparator | Dietary Supplement: PalmitoylethanolamidePatiënts 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 | Dietary Supplement: PalmitoylethanolamidePatiënts 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 | Dietary Supplement: PalmitoylethanolamidePatiënts 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 | Dietary Supplement: PalmitoylethanolamidePatiënts that do not take PPI at baseline are randomized in the OFF-PPI PEA arm or OFF-PPI placebo arm |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palmitoylethanolamide8-week treatment 3x400 mg per day | Dietary supplement | PEA + participant OFF-PPI, PEA + participant ON-PPI, Placebo + Participant ON-PPI, Placebo + participant OFF-PPI |
Primary outcome
Effect (change) on the Leuven-postprandial distress scale (LPDS) (0-15), higher score indicating more symptoms)
Time frame: Comparison after 8 weeks of treatment with placebo or PEA
Validated questionnaire for measurement of dyspeptic symptoms in functional dyspepsia
3 secondary outcomes
Effect of PEA supplementation on duodenal permeability
Time frame: Comparison after 8 weeks of treatment with placebo or PEA
Effect of PEA supplementation on duodenal inflammation
Time frame: Comparison after 8 weeks of treatment with placebo or PEA
Effect of PEA on gastric emptying
Time frame: Comparison after 8 weeks of treatment with placebo or PEA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Background: PubMed 33065341Sarnelli 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palmitoylethanolamide in people with Dyspepsia and Other Specified Disorders of Function of Stomach, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect (change) on the Leuven-postprandial distress scale (LPDS) (0-15), higher score indicating more symptoms) (time frame: Comparison after 8 weeks of treatment with placebo or PEA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05877781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.