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DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00424905
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : December 1, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Diseases Drug: Bacillus clausii Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : December 2006
Actual Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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)

Primary Outcome Measures :
  1. Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis. [ Time Frame: between samples obtained at baseline and follow-up ]

Secondary Outcome Measures :
  1. Changes from baseline of body weight [ Time Frame: During the total study period ]
  2. Assessment of abdominal symptoms [ Time Frame: Daily ]
  3. Presence of Bacillus clausii spores in feces [ Time Frame: after heat shock treatment on selective medium. ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00424905

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Milan, Italy
Sponsors and Collaborators
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Study Director: Georges Paizis, MD Sanofi
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Responsible Party: Medical Affairs Medical Director, Sanofi-aventis administrative office Identifier: NCT00424905    
Other Study ID Numbers: PM_L_0199
EudraCT # : 2006-002482-39
First Posted: January 22, 2007    Key Record Dates
Last Update Posted: December 1, 2008
Last Verified: November 2008
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases