Palmitoylethanolamide and Polydatin in Pediatric Irritable Bowel Syndrome

NCT05867693 | Unknown

• 1 other identifier: 2022/ST/235
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in the abdominal pain symptoms

  The primary outcome will be the change in the abdominal pain symptoms (frequency and severity) according to validated score from baseline to the end of the treatment period. Secondary outcome will be modifications of intestinal permeability and fecal caprotectine. The primary outcome will be the change in the abdominal pain symptoms (frequency and severity) according to validated score from baseline to the end of the treatment period.

  12 weeks

Secondary Outcomes (2)

• Change in intestinal permeability

  12 weeks

• Change in fecal calprotectin

  12 weeks

Study Arms (2)

IBS patients assigned to palmithoylethanolamide/polydatin treatment

EXPERIMENTAL

Eligible patients (patients with symptoms meeting Rome IV criteria for diagnosis of IBS) will be randomly assigned to either co-micronised form palmithoylethanolamide/polydatin 200 mg/20 mg

Dietary Supplement: palmithoylethanolamide/polydatin

IBS patients assigned to placebo treatment

PLACEBO COMPARATOR

Eligible patients (patients with symptoms meeting Rome IV criteria for diagnosis of IBS) will be randomly assigned to Placebo

Dietary Supplement: placebo

Interventions

palmithoylethanolamide/polydatin DIETARY_SUPPLEMENT

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.

IBS patients assigned to palmithoylethanolamide/polydatin treatment

placebo DIETARY_SUPPLEMENT

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

IBS patients assigned to placebo treatment

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• positive diagnosis of all IBS subtypes,
• negative fecal calprotectine
• nagative anti-transglutaminasi antibodies

You may not qualify if:

• Current use of nonsteroidal anti-infl ammatory drugs, corticosteroids and mast cell stabilisers
• Use of topical or systemic antibiotics in the last month,
• Continuous use of stimulant laxatives,
• Major abdominal surgery, inflammatory bowel disease, infectious diarrhoea, allergic diseases and other organic or psychiatric disorders.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Prof Giovanni Di Nardo

Roma, Rome, 03040, Italy

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

polydatin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Giovanni Di Nardo, Prof

  Sapienza University of Rome, Faculty of Medicine and Psychology, Sant'Andrea University Hospital

  STUDY CHAIR

Central Study Contacts

Giovanni Di Nardo, Prof

CONTACT

+39 339 726 7637; giovanni.dinardo@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 22, 2023
• Study Start: April 19, 2023
• Primary Completion: October 19, 2023
• Study Completion: April 19, 2024
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)