Diarrhea, Infantile
Conditions
Brief summary
To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.
Interventions
DRUGBacillus Clausii Multi ATB Resist
Twice daily dose of 1 vial of 1x10\^9 of Bacillus clausii spores, orally suspension in water
DRUGPlacebo
Matched placebo
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
* Clinically stable children with mild to moderate illness admitted for treatment of bacterial infection.
Exclusion criteria
* Children with unstable medical condition * In any form of immunocompromized state * With contraindication to take medication * Has taken antibiotics for 3 weeks before start of trial. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the incidence of antibiotic-associated diarrhea (relative risk) | From baseline to end of treatment |
| All adverse event regardless of seriousness or relationship to the study drug | From baseline to end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in the number of antibiotic-associated diarrhea events per day | From baseline to end of treatment |
| Reduction in the severity of diarrhea events | 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. | From baseline to end of treatment |
| Reduction in C. dificille -associated diarrhea. | From baseline to end of treatment |
Countries
Philippines
Outcome results
None listed