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Completed

NCT Number: NCT00447161

Preventing Antibiotic-Associated DiarRhea Using Erceflora

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

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Key information

Conditions

Diarrhea, Infantile Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Manila, Philippines

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bacillus Clausii Multi ATB Resist

Drug

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

Placebo

Drug

Matched placebo

Primary outcomes

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

    Time frame: From baseline to end of treatment

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

    Time frame: From baseline to end of treatment

Secondary outcomes

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

    Time frame: From baseline to end of treatment

  2. Reduction in the severity of diarrhea events

    Time frame: From baseline to end of treatment

  3. Reduction in Gastrointestinal-related symptoms (nausea, vomiting, abdominal pain)over-all reduction in the number of hospitalization days beween control and treatment groups.

    Time frame: From baseline to end of treatment

  4. Reduction in C. dificille -associated diarrhea.

    Time frame: From baseline to end of treatment

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Bacillus 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

Acronym: PADRE

Important dates

Study start
2006
Primary completion
2007
First posted
Mar 14, 2007
Registry last updated
Sep 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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