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DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect
This study has been completed.
First Received: January 19, 2007   Last Updated: November 28, 2008   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00424905
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Diseases
Drug: Bacillus clausii
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis. [ Time Frame: between samples obtained at baseline and follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes from baseline of body weight [ Time Frame: During the total study period ] [ Designated as safety issue: No ]
  • Assessment of abdominal symptoms [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Presence of Bacillus clausii spores in feces [ Time Frame: after heat shock treatment on selective medium. ] [ Designated as safety issue: No ]
  • Number and rate of patients with GI symptoms and time to first development of symptoms. [ Time Frame: recorded in a daily diary card for the total study period ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: December 2006
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.
2: No Intervention
No treatment (reference group)

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424905

Locations
Italy
Sanofi-aventis
Milan, Italy
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Georges Paizis, MD Sanofi-Aventis
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi-aventis administrative office ( Medical Affairs Medical Director )
Study ID Numbers: PM_L_0199, EudraCT # : 2006-002482-39
Study First Received: January 19, 2007
Last Updated: November 28, 2008
ClinicalTrials.gov Identifier: NCT00424905     History of Changes
Health Authority: Italy: Ministry of Health

Study placed in the following topic categories:
Anti-Infective Agents
Anti-Bacterial Agents
Digestive System Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gastrointestinal Diseases

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Digestive System Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gastrointestinal Diseases
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 02, 2009