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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
History of Changes
  Purpose

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


Condition Intervention Phase
Diarrhea, Infantile
 Drug: Bacillus Clausii Multi ATB Resist
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 323
Study Start Date: July 2006
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bacillus Clausii Multi ATB Resist
 Drug: Bacillus Clausii Multi ATB Resist
Twice daily dose of 1 vial of 1x10^9 of Bacillus clausii spores, orally suspension in water
Placebo Comparator: 2
Placebo
 Drug: Placebo
Matched placebo

  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447161

Locations
Philippines
Sanofi-Aventis
Manila, Philippines
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Paz Figueroa Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00447161     History of Changes
Other Study ID Numbers: ENTER_L_01125
Study First Received: March 13, 2007
Last Updated: September 4, 2008
Health Authority: Philippines: National Institute of Health

Additional relevant MeSH terms:
Diarrhea
Diarrhea, Infantile
Signs and Symptoms, Digestive
Signs and Symptoms
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013