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To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Bacillus Clausii Multi ATB Resist |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacillus Clausii Multi ATB Resist | Drug | Twice daily dose of 1 vial of 1x10^9 of Bacillus clausii spores, orally suspension in water |
|
| Measure | Description | 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Paz Figueroa | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Manila | Philippines |
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| ID | Term |
|---|---|
| D003968 | Diarrhea, Infantile |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Drug | Matched placebo |
|
| 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 |