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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 28, 2014