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

NCT03539913 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2019-01-22

No results posted yet for this study

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.

Conditions

  • Acute Gastroenteritis

Interventions

BIOLOGICAL

Probiotic : Saccharomyces boulardii

Treatment for 5 days

BIOLOGICAL

Probiotic : Bacillus clausii

Treatment for 5 days

Sponsors & Collaborators

  • Biocodex

    lead INDUSTRY

Principal Investigators

  • Carine FRANCOIS · Biocodex

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03539913 on ClinicalTrials.gov