Preventing Antibiotic-Associated DiarRhea Using Erceflora - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00447161

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 IV

MedlinePlus related topics: Antibiotics Diarrhea Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

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
1: Experimental 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
2: Placebo Comparator 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-Aventis

Investigators

Study Director:

Paz Figueroa

Sanofi-Aventis

More Information

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

Study placed in the following topic categories:

Signs and Symptoms
Diarrhea
Signs and Symptoms, Digestive
Diarrhea, Infantile

ClinicalTrials.gov processed this record on January 16, 2009