Trials / Completed
CompletedNCT00447161
Preventing Antibiotic-Associated DiarRhea Using Erceflora
Bacillus Clausii in Preventing Antibiotic-Associated Diarrhea Among Filipino Infant and Children: A Multi-Center, Randomized, Open-Label Controlled (Treatment vs No Treatment) Clinical Trial of Efficacy and Safety
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 323 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 6 Months – 12 Years
- Healthy volunteers
- Not accepted
Summary
To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bacillus Clausii Multi ATB Resist | Twice daily dose of 1 vial of 1x10\^9 of Bacillus clausii spores, orally suspension in water |
| DRUG | Placebo | Matched placebo |
Timeline
- Start date
- 2006-07-01
- Primary completion
- 2007-10-01
- First posted
- 2007-03-14
- Last updated
- 2008-09-05
Locations
1 site across 1 country: Philippines
Source: ClinicalTrials.gov record NCT00447161. Inclusion in this directory is not an endorsement.