Preventing Antibiotic-Associated DiarRhea Using Erceflora

NCT00447161 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2008-09-05

No results posted yet for this study

Summary

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

Conditions

  • Diarrhea, Infantile

Interventions

DRUG

Bacillus Clausii Multi ATB Resist

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

DRUG

Placebo

Matched placebo

Sponsors & Collaborators

Principal Investigators

  • Paz Figueroa · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-10-31

Countries

  • Philippines

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00447161 on ClinicalTrials.gov