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Preventing Antibiotic-Associated DiarRhea Using Erceflora (PADRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00447161
Recruitment Status : Completed
First Posted : March 14, 2007
Last Update Posted : September 5, 2008
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Diarrhea, Infantile Drug: Bacillus Clausii Multi ATB Resist Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
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
Study Start Date : July 2006
Primary Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Reduction in the incidence of antibiotic-associated diarrhea (relative risk) [ Time Frame: From baseline to end of treatment ]
  2. All adverse event regardless of seriousness or relationship to the study drug [ Time Frame: From baseline to end of treatment ]

Secondary Outcome Measures :
  1. Reduction in the number of antibiotic-associated diarrhea events per day [ Time Frame: From baseline to end of treatment ]
  2. Reduction in the severity of diarrhea events [ Time Frame: From baseline to end of treatment ]
  3. 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 ]
  4. Reduction in C. dificille -associated diarrhea. [ Time Frame: From baseline to end of treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447161


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00447161     History of Changes
Other Study ID Numbers: ENTER_L_01125
First Posted: March 14, 2007    Key Record Dates
Last Update Posted: September 5, 2008
Last Verified: September 2008

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