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Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children

NCT02169817 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 629

Last updated 2016-01-21

No results posted yet for this study

Summary

Primary Objective:

To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in the duration of acute community-acquired diarrhea in Latin American children.

Secondary Objectives:

To evaluate the clinical safety of Enterogermina in acute diarrhea in children and to demonstrate its effectiveness on stool frequency, stool consistency, and number of vomiting episodes.

To evaluate parent's overall global assessment. To evaluate the safety and effectiveness of Enterogermina in norovirus acute gastroenteritis (AGE).

Conditions

  • Acute Gastroenteritis

Interventions

DRUG

Bacillus clausii

Pharmaceutical form:aqueous suspension Route of administration: oral

DRUG

Oral Rehydration Therapy

Pharmaceutical form:vials/sachets for solution Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Argentina
  • Brazil
  • Colombia
  • Mexico
  • Peru

Study Locations

More Related Trials

Entities

Companies

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 NCT02169817 on ClinicalTrials.gov