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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

January 19, 2007
November 28, 2008
December 2006
December 2007   (final data collection date for primary outcome measure)
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 ]
Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis.
Complete list of historical versions of study NCT00424905 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes from baseline of body weight
  • Assessment of abdominal symptoms
  • Presence of Bacillus clausii spores in feces
  • Number and rate of patients with GI symptoms and time to first development of symptoms.
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastrointestinal Diseases
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.
  • Experimental: 1
    Enterogermina® vials containing 2×109 spores of polyantibiotic resistant Bacillus clausii (test drug)
    Intervention: Drug: Bacillus clausii
  • No Intervention: 2
    No treatment (reference group)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
December 2007   (final data collection date for primary outcome measure)

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.

Both
1 Year to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00424905
PM_L_0199, EudraCT # : 2006-002482-39
Not Provided
Medical Affairs Medical Director, Sanofi-aventis administrative office
Sanofi
Not Provided
Study Director: Georges Paizis, MD Sanofi
Sanofi
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP