TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children
This study has been completed.
Information provided by:
First received: November 4, 2005
Last updated: January 10, 2011
Last verified: January 2011
- To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days.
- To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Comparative Efficacy and Safety of a Bacillus Clausii Probiotic Strain Versus Placebo in the Treatment of Acute Diarrhoea in Children|
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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:
- 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
|Study Start Date:||May 2004|
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