Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00457353 | ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children | PHASE3 | COMPLETED | 264 | — | — | Mar 1, 2007 | - | Jan 21, 2009 | 1 | India |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Administration of oral rehydration therapy with Bacillus clausii probiotic strain (1 vial twice daily, each vial containing 2 billion spores of Bacillus clausii) |
| 2 | PLACEBO_COMPARATOR | Administration of Oral rehydration therapy |
| Name | Type | Description |
|---|---|---|
| Bacillus Clausii | DRUG | For 5 days |
| Oral rehydration therapy | OTHER | For 5 days |
Inclusion Criteria: * Non hospitalised infants and children attending clinic/outpatients with acute diarrhea (\>3 liquid or watery stools occurring in a 24-hour period) of less than 48 hours duration Exclusion Criteria: * History of presence of blood, pus, or mucus in stools * Severe dehydration ...