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. - DIAMANTE

Conditions: 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: 6.1Level: SOCClassification code 10017947

Registration Number: EUCTR2006-002482-39-IT

Lead Sponsor: SANOFI-AVENTIS OTC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

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

- 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.