DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect

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.

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases
• Intervention / Treatment: Drug: Bacillus clausii

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Enterogermina® vials containing 2×109 spores of polyantibiotic resistant Bacillus clausii (test drug)	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.
No Intervention: 2; No treatment (reference group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis.	between samples obtained at baseline and follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Georges Paizis, MD, Sanofi

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: January 19, 2007
• First Submitted That Met QC Criteria: January 19, 2007
• First Posted (Estimate): January 22, 2007

Study Record Updates

• Last Update Posted (Estimate): December 1, 2008
• Last Update Submitted That Met QC Criteria: November 28, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: PM_L_0199; EudraCT # : 2006-002482-39