Preventing Antibiotic-Associated DiarRhea Using Erceflora

Diarrhea, Infantile Clinical Trial

— PADRE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447161
• Other study ID #: ENTER_L_01125
• Status: Completed
• Phase: Phase 4
• First received: March 13, 2007
• Last updated: September 4, 2008
• Start date: July 2006

Study information

• Verified date: September 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: National Institute of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea, Infantile

Intervention

Drug:
• Bacillus Clausii Multi ATB Resist
Twice daily dose of 1 vial of 1x10^9 of Bacillus clausii spores, orally suspension in water
• Placebo
Matched placebo

Locations

Country	Name	City	State
Philippines	Sanofi-Aventis	Manila

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the incidence of antibiotic-associated diarrhea (relative risk)		From baseline to end of treatment	No
Primary	All adverse event regardless of seriousness or relationship to the study drug		From baseline to end of treatment	Yes
Secondary	Reduction in the number of antibiotic-associated diarrhea events per day		From baseline to end of treatment	No
Secondary	Reduction in the severity of diarrhea events		From baseline to end of treatment	No
Secondary	Reduction in Gastrointestinal-related symptoms (nausea, vomiting, abdominal pain)over-all reduction in the number of hospitalization days beween control and treatment groups.		From baseline to end of treatment	No
Secondary	Reduction in C. dificille -associated diarrhea.		From baseline to end of treatment	No