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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

March 2, 2012
January 23, 2014
February 2012
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01551186 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria
The Use of the Probiotic, Lactobacillus Rhamnosus GG to Evaluate Colonization With Antimicrobial Resistant Bacteria in High Risk Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Infectious Disease of Digestive Tract
Dietary Supplement: Lactobacillus rhamnosus GG
1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Other Name: Culturelle
  • Experimental: Probiotic
    Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis
    Intervention: Dietary Supplement: Lactobacillus rhamnosus GG
  • No Intervention: Standard of Care
    Patients in the control arm will receive standard care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01551186
201106182, 1U54CK000162
No
Washington University School of Medicine
Washington University School of Medicine
Centers for Disease Control and Prevention
Principal Investigator: Victoria J Fraser, MD Washington University School of Medicine
Washington University School of Medicine
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP