Clinical Trials Logo
  1. Home
  2. Irritable Bowel Syndrome
  3. NCT05867693

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 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)

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05867693
Study type Interventional
Source University of Roma La Sapienza
Contact Giovanni Di Nardo, Prof
Phone +39 339 726 7637
Email giovanni.dinardo@uniroma1.it
Status Recruiting
Phase N/A
Start date April 19, 2023
Completion date April 19, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT03720314 - Microbiota Profiling in IBS
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT05213910 - Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains N/A
Recruiting NCT05985018 - Traditional Dietary Advice Vs. Mediterranean Diet in IBS N/A
Completed NCT04486469 - Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study. N/A
Completed NCT06407609 - Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS N/A
Completed NCT04656730 - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas Phase 4
Completed NCT04145856 - Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico Phase 4
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Active, not recruiting NCT03586622 - One Year Home Monitoring and Treatment of IBS Patients N/A
Completed NCT05207618 - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant N/A
Not yet recruiting NCT06369753 - Visible Abdominal Distension N/A
Not yet recruiting NCT05157867 - In Vivo Effects of Amylase Trypsin Inhibitors N/A
Not yet recruiting NCT05100719 - The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION) N/A
Recruiting NCT05001997 - Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome N/A
Recruiting NCT02953171 - Probiotics in the Treatment of Irritable Bowel Syndrome N/A
Completed NCT02977975 - Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome N/A
Completed NCT03266068 - Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
Completed NCT03318614 - Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster Phase 2/Phase 3
Completed NCT02980406 - The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level N/A