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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00447161 |
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Date of registration:
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13/03/2007 |
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Primary sponsor: |
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Public title:
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Preventing Antibiotic-Associated DiarRhea Using Erceflora
PADRE |
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Scientific title:
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Bacillus 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 |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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323 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00447161 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Philippines
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Contacts
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Name:
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Paz Figueroa |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi-Aventis |
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Key inclusion & exclusion criteria
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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.
Age minimum:
6 Months
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diarrhea, Infantile
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Intervention(s)
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Drug: Bacillus Clausii Multi ATB Resist
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Drug: Placebo
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Primary Outcome(s)
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All adverse event regardless of seriousness or relationship to the study drug
[Time Frame: From baseline to end of treatment]
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Reduction in the incidence of antibiotic-associated diarrhea (relative risk)
[Time Frame: From baseline to end of treatment]
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Secondary Outcome(s)
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Reduction in C. dificille -associated diarrhea.
[Time Frame: From baseline to end of treatment]
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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]
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Reduction in the number of antibiotic-associated diarrhea events per day
[Time Frame: From baseline to end of treatment]
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Reduction in the severity of diarrhea events
[Time Frame: From baseline to end of treatment]
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Secondary ID(s)
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ENTER_L_01125
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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