DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect

Gastrointestinal Diseases Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424905
• Other study ID #: PM_L_0199
• Secondary ID: EudraCT # : 2006
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2007
• Last updated: November 28, 2008
• Start date: December 2006

Study information

• Verified date: November 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Respiratory Tract Infections

Intervention

Drug:
• Bacillus 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.

Locations

Country	Name	City	State
Italy	Sanofi-Aventis	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis.		between samples obtained at baseline and follow-up	No
Secondary	Changes from baseline of body weight		During the total study period	No
Secondary	Assessment of abdominal symptoms		Daily	No
Secondary	Presence of Bacillus clausii spores in feces		after heat shock treatment on selective medium.	No
Secondary	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	No