NCT00447161

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

September 5, 2008

Status Verified

September 1, 2008

Enrollment Period

1.3 years

First QC Date

March 13, 2007

Last Update Submit

September 4, 2008

Conditions

Diarrhea, Infantile

Outcome Measures

Primary Outcomes (2)

  • Reduction in the incidence of antibiotic-associated diarrhea (relative risk)

    From baseline to end of treatment

  • All adverse event regardless of seriousness or relationship to the study drug

    From baseline to end of treatment

Secondary Outcomes (4)

  • Reduction in the number of antibiotic-associated diarrhea events per day

    From baseline to end of treatment

  • Reduction in the severity of diarrhea events

    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.

    From baseline to end of treatment

  • Reduction in C. dificille -associated diarrhea.

    From baseline to end of treatment

Study Arms (2)

1

EXPERIMENTAL

Bacillus Clausii Multi ATB Resist

Drug: Bacillus Clausii Multi ATB Resist

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Bacillus Clausii Multi ATB ResistDRUG

Twice daily dose of 1 vial of 1x10\^9 of Bacillus clausii spores, orally suspension in water

1
PlaceboDRUG

Matched placebo

2

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinically stable children with mild to moderate illness admitted for treatment of bacterial infection.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Manila, Philippines

Location

MeSH Terms

Conditions

Diarrhea, Infantile

Condition Hierarchy (Ancestors)

DiarrheaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paz Figueroa

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 13, 2007

First Posted

March 14, 2007

Study Start

July 1, 2006

Primary Completion

October 1, 2007

Last Updated

September 5, 2008

Record last verified: 2008-09

Locations

PH(1)