A Phase 4 interventional study of Bacillus Clausii Multi ATB Resist and Placebo in Diarrhea, Infantile, sponsored by Sanofi. Completed at 1 site in Philippines. Open to participants aged 6 Months to 12 Years. Per ClinicalTrials.gov, last updated 2008-09-05.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.
852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.
This study's enrollment of 323 is above the median of 136 across 713 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
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Bacillus Clausii Multi ATB Resist
Drug: Bacillus Clausii Multi ATB Resist
Placebo
Drug: Placebo
Twice daily dose of 1 vial of 1x10\^9 of Bacillus clausii spores, orally suspension in water
Matched placebo
Reduction in the incidence of antibiotic-associated diarrhea (relative risk)
Time frame: From baseline to end of treatment
All adverse event regardless of seriousness or relationship to the study drug
Time frame: From baseline to end of treatment
Reduction in the number of antibiotic-associated diarrhea events per day
Time frame: From baseline to end of treatment
Reduction in the severity of diarrhea events
Time frame: From baseline to end of treatment
Reduction in Gastrointestinal-related symptoms (nausea, vomiting, abdominal pain)over-all reduction in the number of hospitalization days beween control and treatment groups.
Time frame: From baseline to end of treatment
Reduction in C. dificille -associated diarrhea.
Time frame: From baseline to end of treatment
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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Sanofi