DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00424905
First received: January 19, 2007
Last updated: November 28, 2008
Last verified: November 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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
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)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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

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

ClinicalTrials.gov processed this record on September 30, 2014