Palmitoylethanolamide and Polydatin in Pediatric Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Palmitoylethanolamide and Polydatin in Pediatric Irritable Bowel Syndrome: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867693
• Other study ID #: 2022/ST/235
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2023
• Est. completion date: April 19, 2024

Study information

• Verified date: May 2023
• Source: University of Roma La Sapienza
• Contact: Giovanni Di Nardo, Prof
• Phone: +39 339 726 7637
• Email: giovanni.dinardo[@]uniroma1.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

The study will include a 2-week screening period, and a 12-week placebo-controlled treatment period . After the screening phase, eligible patients will be randomly assigned to either co-micronised form palmithoylethanolamide/polydatin 200 mg/20 mg, or the equivalent placebo (without the active treatment, replaced by equal amount of microcrystalline cellulose), three times a day, in a 1:1 ratio, for 12 weeks. Study visits were conducted every 4 weeks during the treatment period. All the subjects will be blindly allocated by means of scratch cards to one of the two treatment groups according to a computer-generated randomisation list provided by our statistician. A validated program will be used by an independent statistician to generate a randomisation list with blocks, block size = 4, pre-allocated to centres. Patients and study investigators will be blinded to the randomisation codes. The codes will be kept confidential until the end of the study when the randomisation code will be broken after the database lock.

After the screening visit and at the end of treatment all subjects will undergo intestinal permeability test and fecal calprotectin assay. Calprotectin assay will be performed using a commercially available enzyme-linked immunosorbent assay test (Calprest Eurospital, Trieste, Italy). According to the manufacturer, calprotectin levels exceeding 100 mg/kg were considered positive. Intestinal permeability will be evaluated using a liquid chromatography/mass spectrometry method previously published .

All subjects will undergo a formal clinical assessment and will be further phenotyped using validated questionnaires. Number of bowel movements per day and/or week and bowel habit characteristics, will be assessed by the Bristol stool scale.

The protocol will be approved by an independent ethics committee and conducted according to the Declaration of Helsinki and the principles of good clinical practice. The trial will be registered in a public registry.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 19, 2024
• Est. primary completion date: October 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• positive diagnosis of all IBS subtypes,

• negative fecal calprotectine

• nagative anti-transglutaminasi antibodies

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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-a, 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.
• placebo
After the screening phase, eligible patients will be randomly assigned to equivalent placebo

Locations

Country	Name	City	State
Italy	Prof Giovanni Di Nardo	Roma	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in intestinal permeability	Secondary outcome will be modifications of intestinal permeability.Intestinal permeability will be evaluated using a liquid chromatography/mass spectrometry method.	12 weeks
Secondary	Change in fecal calprotectin	Outcame 3 will be modification of fecal calprotectin. Calprotectin levels exceeding 100 mg/kg were considered positive	12 weeks