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The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria

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ClinicalTrials.gov Identifier: NCT01551186
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Infectious Disease of Digestive Tract Dietary Supplement: Lactobacillus rhamnosus GG Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551186


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Victoria J Fraser, MD Washington University School of Medicine

Publications:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01551186     History of Changes
Other Study ID Numbers: 201106182
1U54CK000162 ( U.S. NIH Grant/Contract )
First Posted: March 12, 2012    Key Record Dates
Results First Posted: December 17, 2018
Last Update Posted: December 17, 2018
Last Verified: December 2018

Keywords provided by Washington University School of Medicine:
Probiotics

Additional relevant MeSH terms:
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Communicable Diseases
Infection
Anti-Bacterial Agents
Anti-Infective Agents