Status:
COMPLETED
DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect
Lead Sponsor:
Sanofi
Conditions:
Gastrointestinal Diseases
Eligibility:
All Genders
1-5 years
Phase:
PHASE4
Brief 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-treate...
Eligibility Criteria
Inclusion
- Subjects with persistency of symptoms and requiring antibiotics for bacterial upper respiratory tract infections, i.e. complicated acute otitis media (diagnosed by otoscopic examination) or beta-haemolytic streptococcal pharyngo-tonsillitis (diagnosed by pharyngeal swab and rapid antigen detection test or positive culture);
- Outpatients or patients attending an emergency room for both diagnoses, and inpatients in case of complicated acute otitis media;
- Written informed consent from both parents.
Exclusion
- History of clinically significant chronic diseases, or chronic diseases necessitating the use of continuous drug therapies, or of any disease that may interfere with the successful completion or the objectives of the trial;
- Clinical evidence of relevant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological or of any disease that may interfere with the successful completion or the objectives of the trial;
- Use of antibiotics, prebiotics or probiotics (medications or dietetic supplements) in the last 2 weeks prior to study entry;
- Hypersensitivity to the investigational product;
- Subjects enrolled in another trial in the previous three months.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00424905
Start Date
December 1 2006
Last Update
December 1 2008
Active Locations (1)
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1
Sanofi-Aventis
Milan, Italy