Completed

PADREBacillus 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

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What is being tested

Bacillus Clausii Multi ATB Resist

+ Placebo

Drug
Who is being recruted

Diarrhea+2

+ Diarrhea, Infantile

+ Signs and Symptoms

From 6 Months to 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: July 2006
See protocol details

Summary

Principal SponsorSanofi
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2006

Actual date on which the first participant was enrolled.

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

Official TitleBacillus 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
NCT00447161
Principal SponsorSanofi
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

323 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 Months to 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DiarrheaDiarrhea, InfantileSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and Symptoms

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Bacillus Clausii Multi ATB Resist

Group II

Placebo
Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sanofi-Aventis

Manila, PhilippinesOpen Sanofi-Aventis in Google Maps
CompletedOne Study Center