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 . MedDRA version: 6.1 Level: SOC Classification code 10017947
Conditions
Interventions
Trade Name: ENTEROGERMINA*OS 20FL 2MLD/5ML
Pharmaceutical Form: Oral suspension
INN or Proposed INN: VARI
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20000000
Sponsors
SANOFI-AVENTIS OTC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Children of either sex, aged 1 and 6 years; - 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. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of clinically significant chronic diseases, or chronic diseases necessitating the use of continuative 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 products; - Subjects and/or parents with unstable personality or not able to comply with the study procedures; - Subjects enrolled in another trial in the previous three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of Bacillus clausii Enterogermina on fecal microbial flora using PCR-DGGE method in antibiotic-treated children with complicated acute otitis media or beta-hemolytic streptococcal pharyngo-tonsillitis;Secondary Objective: To assess the effects of Bacillus clausii Enterogermina on GI symptoms and signs in antibiotic-treated children with complicated acute otitis media or beta-hemolytic streptococcal pharyngo-tonsillitis; To evaluate the presence of Bacillus clausii in fecal samples; To assess the safety and tolerability of Bacillus clausii Enterogermina through physical examination and adverse events monitoring.;Primary end point(s): - Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis differences in bacterial groups between samples obtained at baseline and follow-up ; | — |
Countries
Italy
Outcome results
None listed