Clinical trial
ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children
NCT00457353 · Sanofi, Industry · Completed
Key facts
| NCT number | NCT00457353 |
|---|---|
| Title | ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children |
| Official title | 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. |
| Acronym | ENIGMA |
| Lead sponsor | Sanofi, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Gastroenteritis |
| Intervention type | Drug, Other |
| Interventions | Bacillus Clausii, Oral rehydration therapy |
| Enrollment | 264 |
| Start date | Mar 1, 2007 |
| Primary completion | Dec 1, 2007 |
| First posted | Apr 6, 2007 |
| Last update posted | Jan 21, 2009 |
| Countries | India |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: