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DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect

NCT ID: NCT00424905

Last Updated: 2008-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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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

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Sanofi-aventis administrative office

Principal Investigators

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Georges Paizis, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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EudraCT # : 2006-002482-39

Identifier Type: -

Identifier Source: secondary_id

PM_L_0199

Identifier Type: -

Identifier Source: org_study_id