Irritable Bowel Syndrome Clinical Trial
Official title:
Palmitoylethanolamide and Polydatin in Pediatric Irritable Bowel Syndrome: a Randomized Controlled Trial
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)
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Prof Giovanni Di Nardo | Roma | Rome |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
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 |
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