TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00265369|
Recruitment Status : Completed
First Posted : December 14, 2005
Last Update Posted : January 11, 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.
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea||Drug: Spores of Bacillus Clausii Probiotic Strain||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparative Efficacy and Safety of a Bacillus Clausii Probiotic Strain Versus Placebo in the Treatment of Acute Diarrhoea in Children|
|Study Start Date :||May 2004|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265369
|Study Director:||Gilles Perdriset, MD||Sanofi|