DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect

NCT ID: NCT00424905

Last Updated: 2008-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31

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.

Conditions

Gastrointestinal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Enterogermina® vials containing 2×109 spores of polyantibiotic resistant Bacillus clausii (test drug)

Group Type: EXPERIMENTAL

Bacillus clausii

Intervention Type: DRUG

2 Enterogermina vials/day for 12 to 17 days (i.e. during the 5 to 10-days antibiotic treatment and for 7 days thereafter.

2

No treatment (reference group)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Sanofi-aventis administrative office

Principal Investigators

Georges Paizis, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Milan, , Italy

Countries

Italy

Other Identifiers

EudraCT # : 2006-002482-39

Identifier Type: -

Identifier Source: secondary_id

PM_L_0199

Identifier Type: -

Identifier Source: org_study_id