Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preventing Antibiotic-Associated DiarRhea Using Erceflora (PADRE)

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.
 
ClinicalTrials.gov Identifier: NCT00447161
Recruitment Status : Completed
First Posted : March 14, 2007
Last Update Posted : September 5, 2008
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE March 13, 2007
First Posted Date  ICMJE March 14, 2007
Last Update Posted Date September 5, 2008
Study Start Date  ICMJE July 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2008)
  • Reduction in the incidence of antibiotic-associated diarrhea (relative risk) [ Time Frame: From baseline to end of treatment ]
  • All adverse event regardless of seriousness or relationship to the study drug [ Time Frame: From baseline to end of treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2007)
  • Reduction in the incidence of antibiotic-associated diarrhea (relative risk)
  • Safety Outcome: All adverse event regardless of seriousness or relationship to the study drug
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2008)
  • Reduction in the number of antibiotic-associated diarrhea events per day [ Time Frame: From baseline to end of treatment ]
  • Reduction in the severity of diarrhea events [ Time Frame: From baseline to end of treatment ]
  • 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 ]
  • Reduction in C. dificille -associated diarrhea. [ Time Frame: From baseline to end of treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2007)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Antibiotic-Associated DiarRhea Using Erceflora
Official Title  ICMJE 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
Brief Summary To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diarrhea, Infantile
Intervention  ICMJE
  • Drug: Bacillus Clausii Multi ATB Resist
    Twice daily dose of 1 vial of 1x10^9 of Bacillus clausii spores, orally suspension in water
  • Drug: Placebo
    Matched placebo
Study Arms  ICMJE
  • Experimental: 1
    Bacillus Clausii Multi ATB Resist
    Intervention: Drug: Bacillus Clausii Multi ATB Resist
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2008)
323
Original Enrollment  ICMJE
 (submitted: March 13, 2007)
324
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00447161
Other Study ID Numbers  ICMJE ENTER_L_01125
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paz Figueroa Sanofi
PRS Account Sanofi
Verification Date September 2008

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