Preventing Antibiotic-Associated DiarRhea Using Erceflora

Phase 4

Completed

• Conditions: Diarrhea, Infantile
• Interventions: Drug: Bacillus Clausii Multi ATB Resist; Drug: Placebo

• Registration Number: NCT00447161
• Lead Sponsor: Sanofi

Brief Summary

To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2007-03-13
• Study First Submitted QC: 2007-03-13
• Study First Posted: 2007-03-14
• Primary Completion: 2007-10
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-04
• Last Update Posted: 2008-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

Inclusion Criteria

• Clinically stable children with mild to moderate illness admitted for treatment of bacterial infection.

Exclusion Criteria

• Children with unstable medical condition
• In any form of immunocompromized state
• With contraindication to take medication
• Has taken antibiotics for 3 weeks before start of trial.

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: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Bacillus Clausii Multi ATB Resist	Bacillus Clausii Multi ATB Resist
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Reduction in the incidence of antibiotic-associated diarrhea (relative risk)	From baseline to end of treatment
All adverse event regardless of seriousness or relationship to the study drug	From baseline to end of treatment

Secondary Outcome Measures

Name	Time	Method
Reduction in the number of antibiotic-associated diarrhea events per day	From baseline to end of treatment
Reduction in the severity of diarrhea events	From baseline to end of treatment
Reduction in Gastrointestinal-related symptoms (nausea, vomiting, abdominal pain)over-all reduction in the number of hospitalization days beween control and treatment groups.	From baseline to end of treatment
Reduction in C. dificille -associated diarrhea.	From baseline to end of treatment

Trial Locations

Locations (1)

Sanofi-Aventis; 🇵🇭 Manila, Philippines