A randomised trial of pleuran in paediatric acute gastroenteritis.

Pleuran, as a potent immunomodulator targeting intestinal immunity with a strong safety profile, could be a potential treatment for acute gastroenteritis. This study evaluates the effect of pleuran on the duration and severity of acute infectious diarrhoea in children. This is a multi-centre, randomised, double-blind, placebo-controlled, CONSORT statement superiority trial. Children aged 2-10 years presenting to hospital with acute gastroenteritis were included. The primary outcome measure was the duration of diarrhoea. Twenty-seven children were enrolled. There were no significant differences between the experimental and control groups regarding duration of diarrhoea, hospitalisation, intravenous rehydration and symptom severity. The administration of Pleuran was well tolerated. In this study, Pleuran was ineffective in the treatment of acute gastroenteritis in children. Further studies are needed to investigate its potential as a nutraceutical in children.Clinical registration: ClinicalTrials.gov ID: NCT03988257 (the date of registration: 17/06/2019). The Medical University of Warsaw Bioethical Committee Approval: KB/45/2018. Nutricia Foundation Grant: RG-3/2018.