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Palmitoylethanolamide and Polydatin in Pediatric Irritable Bowel Syndrome

NCT05867693 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-05-22

No results posted yet for this study

Summary

This will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to study the efficacy and safety of co-micronised palmithoylethanolamide/polydatin in pediatric patients (\> 10 years) with Irritable bowel syndrome (IBS)

Conditions

  • Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

palmithoylethanolamide/polydatin

Palmitoyl-ethanolamide, a saturated fatty acid amide of palmitic acid commonly found in egg yolk and peanuts, is chemically related to anandamide but exhibit low affinity for cannabinoid receptors, and participate in the control of inflammation and nociception mainly via down-regulation of mast cell activity. In addition, palmitoylethanolamide is able to reduce human colonic permeability both in vitro and in vivo. Interestingly, palmithoylethanolamide may act as mast cell modulator as a possible agonist for cannabinoid 2-like receptors; and as agonist for PPAR-α, transient receptor potential vanilloid type 1 (TRPV1), and 'orphan' G protein-coupled receptor 55. For these reasons, palmithoylethanolamide has emerged as potential regulators of nociception. Polydatin, a resveratrol glucoside, is a common dietary component derived from grapes which may act synergistically with palmithoylethanolamide in reducing mast cell activation and local oxidative stress.

DIETARY_SUPPLEMENT

placebo

After the screening phase, eligible patients will be randomly assigned to equivalent placebo

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Giovanni Di Nardo, Prof · Sapienza University of Rome, Faculty of Medicine and Psychology, Sant'Andrea University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2023-10-19
Completion
2024-04-19

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05867693 on ClinicalTrials.gov