Back to resultsDIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect
Primary Purpose
Gastrointestinal Diseases
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Bacillus clausii
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Diseases
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Enterogermina® vials containing 2×109 spores of polyantibiotic resistant Bacillus clausii (test drug)
No treatment (reference group)
Outcomes
Primary Outcome Measures
Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00424905
Brief Title
DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect
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 Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Enterogermina® vials containing 2×109 spores of polyantibiotic resistant Bacillus clausii (test drug)
Arm Title
2
Arm Type
No Intervention
Arm Description
No treatment (reference group)
Intervention Type
Drug
Intervention Name(s)
Bacillus clausii
Intervention Description
2 Enterogermina vials/day for 12 to 17 days (i.e. during the 5 to 10-days antibiotic treatment and for 7 days thereafter.
Primary Outcome Measure Information:
Title
Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis.
Time Frame
between samples obtained at baseline and follow-up
Secondary Outcome Measure Information:
Title
Changes from baseline of body weight
Time Frame
During the total study period
Title
Assessment of abdominal symptoms
Time Frame
Daily
Title
Presence of Bacillus clausii spores in feces
Time Frame
after heat shock treatment on selective medium.
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georges Paizis, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Milan
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect
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