To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
323
Twice daily dose of 1 vial of 1x10\^9 of Bacillus clausii spores, orally suspension in water
Matched placebo
Sanofi-Aventis
Manila, Philippines
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
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