Preventing Antibiotic-Associated DiarRhea Using Erceflora
NCT00447161 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 323
Last updated 2008-09-05
Summary
To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.
Conditions
- Diarrhea, Infantile
Interventions
- DRUG
-
Bacillus Clausii Multi ATB Resist
Twice daily dose of 1 vial of 1x10\^9 of Bacillus clausii spores, orally suspension in water
- DRUG
-
Matched placebo
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Paz Figueroa · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 6 Months
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-07-31
- Primary Completion
- 2007-10-31
Countries
- Philippines
Study Locations
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