Gastrointestinal Diseases
Conditions
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-treated children with complicated acute otitis media or beta-hemolytic streptococcal pharyngo-tonsillitis.
Interventions
DRUGBacillus 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.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis. | between samples obtained at baseline and follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline of body weight | During the total study period |
| Assessment of abdominal symptoms | Daily |
| Presence of Bacillus clausii spores in feces | after heat shock treatment on selective medium. |
| Number and rate of patients with GI symptoms and time to first development of symptoms. | recorded in a daily diary card for the total study period |
Countries
Italy
Outcome results
None listed