Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bacillus Clausii · 1 trial · 1 indication
| 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 ...
Bacillus Clausii is used for gastroenteritis, specifically for the management of diarrhea in children. It is an investigational small molecule being developed by Sanofi. The drug is currently in Phase 3 clinical development, though the specific trial for this indication has been completed.
Sanofi (ticker: SNY) is the developer of Bacillus Clausii. The company is conducting clinical research on this drug for the treatment of gastroenteritis. The drug is currently in Phase 3 development, with one completed clinical trial involving 264 participants.
Bacillus Clausii is in Phase 3 clinical development. The drug is being studied for gastroenteritis, and while the Phase 3 trial has been completed, the drug remains investigational and is not yet approved. Sanofi is the developer of this drug.
Bacillus Clausii has one completed Phase 3 clinical trial, NCT00457353, titled "ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children." This trial enrolled 264 participants with gastroenteritis in India, with a minimum age of 6 months, and was placebo-controlled.
Yes, Bacillus Clausii is the same as Enterogermina, as indicated by the clinical trial title NCT00457353. The trial is studying Enterogermina, which contains Bacillus Clausii, for the management of diarrhea in children with gastroenteritis. Sanofi is the developer of this drug.