Clinical trial NCT00424905: DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Diseases
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis.
timeFrame: between samples obtained at baseline and follow-up
Secondary outcomes:
measure: Changes from baseline of body weight
timeFrame: During the total study period
measure: Assessment of abdominal symptoms
timeFrame: Daily
measure: Presence of Bacillus clausii spores in feces
timeFrame: after heat shock treatment on selective medium.
measure: Number and rate of patients with GI symptoms and time to first development of symptoms.
timeFrame: recorded in a daily diary card for the total study period
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Georges Paizis, MD
role: STUDY_DIRECTOR
References: