Clinical Trial: Preventing Antibiotic-Associated DiarRhea Using Erceflora

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Effica

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

Detailed Summary:
Sponsor: Sanofi

Current Primary Outcome:

  • 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:

  • Reduction in the incidence of antibiotic-associated diarrhea (relative risk)
  • Safety Outcome: All adverse event regardless of seriousness or relationship to the study drug


Current Secondary Outcome:

  • 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:

  • 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.


Information By: Sanofi

Dates:
Date Received: March 13, 2007
Date Started: July 2006
Date Completion:
Last Updated: September 4, 2008
Last Verified: September 2008