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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
A randomised trial of pleuran in paediatric acute gastroenteritis
Katarzyna Wzorek-Łyczko1, Anna Piwowarczyk2, Weronika Woźniak2
1The Department of Pediatrics with Clinical Assessment Unit, Medical University of Warsaw, 63A Żwirki & Wigury Street, Warsaw, 02-091, Poland. katarzynawzorek@vp.pl.
Insights
Pleuran, a potential immunomodulator, did not effectively reduce the duration or severity of acute gastroenteritis in children. Further research is needed to explore its use as a nutraceutical in pediatric populations.
Area of Science:
- Immunology
- Pediatrics
- Gastroenterology
Background:
- Pleuran is recognized for its immunomodulatory properties and safety profile.
- Its potential application in treating acute gastroenteritis, particularly in children, warrants investigation.
Purpose of the Study:
- To evaluate the efficacy of Pleuran in reducing the duration and severity of acute infectious diarrhea in children.
- To assess Pleuran's impact on hospitalization rates and need for intravenous rehydration.
Main Methods:
- A multi-center, randomized, double-blind, placebo-controlled superiority trial.
- Inclusion of children aged 2-10 years with acute gastroenteritis.
- Primary outcome: duration of diarrhea. Secondary outcomes: severity, hospitalization, rehydration needs.
Main Results:
- Twenty-seven children were enrolled in the study.
- No statistically significant differences were observed between the Pleuran and placebo groups for diarrhea duration, hospital stay, intravenous rehydration, or symptom severity.
- Pleuran administration was well-tolerated by all participants.
Conclusions:
- Pleuran demonstrated ineffectiveness as a treatment for acute gastroenteritis in the studied pediatric population.
- Further investigation is recommended to explore Pleuran's potential as a pediatric nutraceutical.
Abstract:
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.
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