PADREBacillus Clausii in Preventing Antibiotic-Associated Diarrhea Among Filipino Infant and Children: A Multi-Center, Randomized, Open-Label Controlled (Treatment vs No Treatment) Clinical Trial of Efficacy and Safety

Bacillus Clausii Multi ATB Resist

Placebo

Reduction in the incidence of antibiotic-associated diarrhea (relative risk)

All adverse event regardless of seriousness or relationship to the study drug

Reduction in the number of antibiotic-associated diarrhea events per day

Reduction in the severity of diarrhea events

Reduction in Gastrointestinal-related symptoms (nausea, vomiting, abdominal pain)over-all reduction in the number of hospitalization days beween control and treatment groups.

Reduction in C. dificille -associated diarrhea.