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Completed

NCT Number: NCT01551186

The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria

The purpose of this study is to evaluate the effectiveness of bacteria called Lactobacillus GG, a Probiotic, in preventing the growth of resistant bacteria in the digestive tract in patients on a ventilator.

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Key information

Conditions

Infectious Disease of Digestive Tract

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults ≥ 18 years old
  • Admission to the Medical ICU
  • Expected to be on Mechanical Ventilation through an endotracheal tube for >48 hours

Exclusion criteria

  • Pregnancy
  • Immunosuppression
  • Prosthetic valve or vascular graft
  • Cardiac trauma
  • Pancreatitis
  • History of rheumatic fever
  • Endocarditis or congenital cardiac abnormality
  • Gastroesophageal or intestinal injury or foregut surgery during the current admission
  • Oropharyngeal mucosal injury
  • Placement of a tracheostomy

Treatment and study plan

Lactobacillus rhamnosus GG

Dietary Supplement

1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis

Other names: Culturelle

Primary outcomes

  1. Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE

    Time frame: Participants will be followed while Intubated, an expected average of 7 days. The outcome will be measured 3 days after enrollment and at the end of intubation, average time 7 days)

    Colonization of the gastrointestinal tract with C. difficile, vancomycin-resistant enterococci, multidrug-resistant Acinetobacter baumannii, and multidrug- resistant Pseudomonas. Colonization occurs when the subject acquires the above organism while in the study.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

The Use of the Probiotic, Lactobacillus Rhamnosus GG to Evaluate Colonization With Antimicrobial Resistant Bacteria in High Risk Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2012
Registry last updated
Dec 17, 2018

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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