Preventing Antibiotic-Associated DiarRhea Using Erceflora (PADRE)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diarrhea, Infantile

Treatments: Drug: Placebo; Drug: Bacillus Clausii Multi ATB Resist

Study type: Interventional

Funder types: Industry

Identifiers

NCT00447161

ENTER_L_01125

Details and patient eligibility

About

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

Enrollment: 323 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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323 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Bacillus Clausii Multi ATB Resist

Treatment:

Drug: Bacillus Clausii Multi ATB Resist

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo