Trials / Completed
CompletedNCT00424905
DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect
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.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 1 Year – 5 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2007-12-01
- First posted
- 2007-01-22
- Last updated
- 2008-12-01
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT00424905. Inclusion in this directory is not an endorsement.