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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
2 Enterogermina vials/day for 12 to 17 days (i.e. during the 5 to 10-days antibiotic treatment and for 7 days thereafter.
Sanofi-Aventis
Milan, Italy
Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis.
Time frame: between samples obtained at baseline and follow-up
Changes from baseline of body weight
Time frame: During the total study period
Assessment of abdominal symptoms
Time frame: Daily
Presence of Bacillus clausii spores in feces
Time frame: after heat shock treatment on selective medium.
Number and rate of patients with GI symptoms and time to first development of symptoms.
Time frame: recorded in a daily diary card for the total study period
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