This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Preventing Antibiotic-Associated DiarRhea Using Erceflora (PADRE)

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: March 13, 2007
Last updated: September 4, 2008
Last verified: September 2008
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
Intervention Model: Crossover Assignment
Masking: None (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 ]
  • All adverse event regardless of seriousness or relationship to the study drug [ Time Frame: From baseline to end of treatment ]

Secondary Outcome Measures:
  • 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 ]

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
Drug: Placebo
Matched placebo


Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00447161

Manila, Philippines
Sponsors and Collaborators
Study Director: Paz Figueroa Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00447161     History of Changes
Other Study ID Numbers: ENTER_L_01125
Study First Received: March 13, 2007
Last Updated: September 4, 2008

Additional relevant MeSH terms:
Diarrhea, Infantile
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents processed this record on September 21, 2017