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

Phase 3

Completed

• Conditions: Gastroenteritis
• Interventions: Other: Oral rehydration therapy; Drug: Bacillus Clausii

• Registration Number: NCT00457353
• Lead Sponsor: Sanofi

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-05
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-06
• Primary Completion: 2007-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-20
• Last Update Posted: 2009-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

• Non hospitalised infants and children attending clinic/outpatients with acute diarrhea (>3 liquid or watery stools occurring in a 24-hour period) of less than 48 hours duration

Exclusion Criteria

• History of presence of blood, pus, or mucus in stools
• Severe dehydration (World Health Organization criteria)
• Severely malnourished patients
• Treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment
• History of conditions known to producing immunodeficiency (Acquired Immune Deficiency Syndrome, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc)
• Known hypersensitivity to Bacillus clausii or other probiotics.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Oral rehydration therapy	Administration of Oral rehydration therapy
1	Bacillus Clausii	Administration of oral rehydration therapy with Bacillus clausii probiotic strain (1 vial twice daily, each vial containing 2 billion spores of Bacillus clausii)

Primary Outcome Measures

Name	Time	Method
Reduction in duration of diarrhea	Throughout the treatment period
Incidence of adverse events	Throughout the study period

Secondary Outcome Measures

Name	Time	Method
Mean number of stools per day	Throughout the treatment period
Effect on consistency of stools	Throughtout the treatment period
Vomiting episodes per day	Throughout the treatment period
Requirement of unscheduled intravenous transfusion	Throughout the study period
Need for hospitalization	Throughout the treatment period

Trial Locations

Locations (1)

Sanofi-Aventis; 🇮🇳 Mumbai, India