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ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children

NCT00457353 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2009-01-21

No results posted yet for this study

Summary

Primary:

* To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea in children

Secondary:

* To evaluate the safety of Enterogermina® in acute diarrhea in Indian children

Conditions

Interventions

DRUG

Bacillus Clausii

For 5 days

OTHER

Oral rehydration therapy

For 5 days

Sponsors & Collaborators

Principal Investigators

  • Shah Pratik · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2007-12-31

Countries

  • India

Study Locations

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Entities

Diseases
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 NCT00457353 on ClinicalTrials.gov