Back to resultsPreventing Antibiotic-Associated DiarRhea Using Erceflora (PADRE)
Primary Purpose
Diarrhea, Infantile
Status
Completed
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
Bacillus Clausii Multi ATB Resist
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea, Infantile
Eligibility Criteria
Inclusion Criteria:
- Clinically stable children with mild to moderate illness admitted for treatment of bacterial infection.
Exclusion Criteria:
- Children with unstable medical condition
- In any form of immunocompromized state
- With contraindication to take medication
- Has taken antibiotics for 3 weeks before start of trial.
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
Placebo Comparator
Arm Label
1
2
Arm Description
Bacillus Clausii Multi ATB Resist
Placebo
Outcomes
Primary Outcome Measures
Reduction in the incidence of antibiotic-associated diarrhea (relative risk)
All adverse event regardless of seriousness or relationship to the study drug
Secondary Outcome Measures
Reduction in the number of antibiotic-associated diarrhea events per day
Reduction in the severity of diarrhea events
Reduction in Gastrointestinal-related symptoms (nausea, vomiting, abdominal pain)over-all reduction in the number of hospitalization days beween control and treatment groups.
Reduction in C. dificille -associated diarrhea.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00447161
Brief Title
Preventing Antibiotic-Associated DiarRhea Using Erceflora
Acronym
PADRE
Official Title
Bacillus Clausii in Preventing Antibiotic-Associated Diarrhea Among Filipino Infant and Children: A Multi-Center, Randomized, Open-Label Controlled (Treatment vs No Treatment) Clinical Trial of Efficacy and Safety
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Infantile
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
323 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Bacillus Clausii Multi ATB Resist
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Bacillus Clausii Multi ATB Resist
Intervention Description
Twice daily dose of 1 vial of 1x10^9 of Bacillus clausii spores, orally suspension in water
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo
Primary Outcome Measure Information:
Title
Reduction in the incidence of antibiotic-associated diarrhea (relative risk)
Time Frame
From baseline to end of treatment
Title
All adverse event regardless of seriousness or relationship to the study drug
Time Frame
From baseline to end of treatment
Secondary Outcome Measure Information:
Title
Reduction in the number of antibiotic-associated diarrhea events per day
Time Frame
From baseline to end of treatment
Title
Reduction in the severity of diarrhea events
Time Frame
From baseline to end of treatment
Title
Reduction in Gastrointestinal-related symptoms (nausea, vomiting, abdominal pain)over-all reduction in the number of hospitalization days beween control and treatment groups.
Time Frame
From baseline to end of treatment
Title
Reduction in C. dificille -associated diarrhea.
Time Frame
From baseline to end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinically stable children with mild to moderate illness admitted for treatment of bacterial infection.
Exclusion Criteria:
Children with unstable medical condition
In any form of immunocompromized state
With contraindication to take medication
Has taken antibiotics for 3 weeks before start of trial.
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
Paz Figueroa
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Manila
Country
Philippines
12. IPD Sharing Statement
Learn more about this trial
Preventing Antibiotic-Associated DiarRhea Using Erceflora
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