DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect

Sanofi

Status and phase

Completed

Phase 4

Conditions

Gastrointestinal Diseases

Treatments

Drug: Bacillus clausii

Study type

Interventional

Funder types

Industry

Identifiers

NCT00424905

EudraCT # : 2006-002482-39

PM_L_0199

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

1 to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.