Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Preventing Antibiotic-Associated DiarRhea Using Erceflora (PADRE)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00447161
First received: March 13, 2007
Last updated: September 4, 2008
Last verified: September 2008

March 13, 2007
September 4, 2008
July 2006
October 2007   (final data collection date for primary outcome measure)
  • Reduction in the incidence of antibiotic-associated diarrhea (relative risk) [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
  • All adverse event regardless of seriousness or relationship to the study drug [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: Yes ]
  • Reduction in the incidence of antibiotic-associated diarrhea (relative risk)
  • Safety Outcome: All adverse event regardless of seriousness or relationship to the study drug
Complete list of historical versions of study NCT00447161 on ClinicalTrials.gov Archive Site
  • Reduction in the number of antibiotic-associated diarrhea events per day [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
  • Reduction in the severity of diarrhea events [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Reduction in C. dificille -associated diarrhea. [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
Preventing Antibiotic-Associated DiarRhea Using Erceflora
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

To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diarrhea, Infantile
  • 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
  • Experimental: 1
    Bacillus Clausii Multi ATB Resist
    Intervention: Drug: Bacillus Clausii Multi ATB Resist
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
323
Not Provided
October 2007   (final data collection date for primary outcome measure)

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.

Both
6 Months to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT00447161
ENTER_L_01125
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Paz Figueroa Sanofi
Sanofi
September 2008

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