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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00424905 |
To assess the effects of Bacillus clausii (Enterogermina®) on fecal microbial flora (using Polymerase Chain Reaction - Denaturing Gradient Gel Electrophoresis - PCR-DGGE - Method) in antibiotic-treated children with complicated acute otitis media or beta-hemolytic streptococcal pharyngo-tonsillitis.
Condition | Intervention | Phase |
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Gastrointestinal Diseases |
Drug: Bacillus clausii |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Evaluation of the Effects of Enterogermina, 2 Billion Bacillus Clausii Spores, on the Intestinal Flora of Children Antibiotic Treated for Bacterial Upper Respiratory Tract Infections: Open, Pilot Study. |
Enrollment: | 60 |
Study Start Date: | December 2006 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Enterogermina® vials containing 2×109 spores of polyantibiotic resistant Bacillus clausii (test drug)
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Drug: Bacillus clausii
2 Enterogermina vials/day for 12 to 17 days (i.e. during the 5 to 10-days antibiotic treatment and for 7 days thereafter.
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2: No Intervention
No treatment (reference group)
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Ages Eligible for Study: | 1 Year to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Responsible Party: | Sanofi-aventis administrative office ( Medical Affairs Medical Director ) |
Study ID Numbers: | PM_L_0199, EudraCT # : 2006-002482-39 |
Study First Received: | January 19, 2007 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00424905 History of Changes |
Health Authority: | Italy: Ministry of Health |
Anti-Infective Agents Anti-Bacterial Agents Digestive System Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Gastrointestinal Diseases |
Anti-Infective Agents Anti-Bacterial Agents Digestive System Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Gastrointestinal Diseases Therapeutic Uses Infection Pharmacologic Actions |