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Preventing Antibiotic-Associated DiarRhea Using Erceflora

NCT ID: NCT00447161

Last Updated: 2008-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

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

Detailed Description

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Conditions

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Diarrhea, Infantile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Bacillus Clausii Multi ATB Resist

Group Type EXPERIMENTAL

Bacillus Clausii Multi ATB Resist

Intervention Type DRUG

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

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched placebo

Interventions

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Bacillus Clausii Multi ATB Resist

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

Intervention Type DRUG

Placebo

Matched placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Paz Figueroa

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Manila, , Philippines

Site Status

Countries

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Philippines

Other Identifiers

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ENTER_L_01125

Identifier Type: -

Identifier Source: org_study_id