Trials / Completed
CompletedNCT00457353
ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children
Phase III Comparative Study to Assess the Efficacy and Safety of Oral Rehydration Therapy (ORT) in Combination With Spores of Bacillus Clausii (Enterogermina)Versus ORT Alone, Administered for 5 Days With the Treatment of Acute Diarrhea in Children.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 264 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 6 Months – 5 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Bacillus Clausii | For 5 days |
| OTHER | Oral rehydration therapy | For 5 days |
Timeline
- Start date
- 2007-03-01
- Primary completion
- 2007-12-01
- First posted
- 2007-04-06
- Last updated
- 2009-01-21
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT00457353. Inclusion in this directory is not an endorsement.