The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01551186
First received: March 2, 2012
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Infectious Disease of Digestive Tract
Dietary Supplement: Lactobacillus rhamnosus GG
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Use of the Probiotic, Lactobacillus Rhamnosus GG to Evaluate Colonization With Antimicrobial Resistant Bacteria in High Risk Patients

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 104
Study Start Date: February 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic
Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis
Dietary Supplement: Lactobacillus rhamnosus GG
1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Other Name: Culturelle
No Intervention: Standard of Care
Patients in the control arm will receive standard care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551186

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Victoria J Fraser, MD Washington University School of Medicine
  More Information

Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01551186     History of Changes
Other Study ID Numbers: 201106182, 1U54CK000162
Study First Received: March 2, 2012
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Probiotics

Additional relevant MeSH terms:
Communicable Diseases
Infection
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014