drugset / Trial / NCT03539913

Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children

NCT03539913

Phase 4 Completed 317 enrolled Biocodex
RandomizedParallel-groupSingle-blindTreatment

Summary

* Primary Objective: o To assess the efficacy of the probiotics in reducing the duration of diarrhea in children suffering from acute gastroenteritis. * Secondary Objectives: * To assess the efficacy of the probiotics in improving the frequency and consistency of stools. * To assess the efficacy of the probiotics in avoiding recurrence of diarrhea. * To assess the efficacy of the probiotics on the disease severity. * To assess the safety and tolerability of the studied probiotics.

Timeline

Start
2017-06-19
Primary completion
2018-06-09
Completion
2018-06-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bacillus clausii Other / unclassified 5 ml
Comparator Saccharomyces boulardii Other / unclassified 250 mg

Indications