TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children
Phase 3
Completed
- Conditions
- Diarrhea
- Registration Number
- NCT00265369
- Lead Sponsor
- Sanofi
- Brief Summary
Primary objective:
* To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days.
Secondary objective:
* To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Duration of diarrhoea as counted from the first intake of the investigational product up to the first appearance of a loose stool followed by two-consecutive normal stools
- Secondary Outcome Measures
Name Time Method Number of infants/children with normal stools at D3, D4, D5, D6 and D7;Mean number of stools per day;Occurrence of vomiting episodes per day after enrolment;Parents'overall global assessment of efficacy at the end of the treatment;other safety criteria
Trial Locations
- Locations (1)
Sanofi-Aventis
🇫🇷Paris, France