Palmitoylethanolamide and Polydatin in Pediatric Irritable Bowel Syndrome

NCT ID: NCT05867693

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-19
• Study Completion Date: 2024-04-19

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)

Detailed 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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IBS patients assigned to palmithoylethanolamide/polydatin treatment

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

Group Type: EXPERIMENTAL

palmithoylethanolamide/polydatin

Intervention Type: 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 placebo treatment

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Prof. Giovanni Di Nardo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giovanni Di Nardo, Prof

Role: STUDY_CHAIR

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

Locations

Prof Giovanni Di Nardo

Roma, Rome, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giovanni Di Nardo, Prof

Role: CONTACT

giovanni.dinardo@uniroma1.it

+39 339 726 7637

Facility Contacts

Giovanni Di Nardo, Prof

Role: primary

giovanni.dinardo@uniroma1.it

+39 339 726 7637

Other Identifiers

2022/ST/235

Identifier Type: -

Identifier Source: org_study_id