DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect

NCT00424905 | Completed Phase 4

• 2 other identifiers: PM_L_0199EudraCT # : 2006-002482-39
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis.

  between samples obtained at baseline and follow-up

Secondary Outcomes (4)

• Changes from baseline of body weight

  During the total study period

• Assessment of abdominal symptoms

  Daily

• Presence of Bacillus clausii spores in feces

  after heat shock treatment on selective medium.

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Bacillus clausii

2

NO INTERVENTION

No treatment (reference group)

Interventions

Bacillus clausii 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.

1

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Milan, Italy

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

clausin peptide, Bacillus clausii

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Georges Paizis, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 22, 2007
• Study Start: December 1, 2006
• Primary Completion: December 1, 2007
• Last Updated: December 1, 2008

Record last verified: 2008-11

Locations

IT (1)