The Use of the Probiotic, Lactobacillus Rhamnosus GG to Evaluate Colonization With Antimicrobial Resistant Bacteria in High Risk Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard of Care
Patients in the control arm will receive standard care
Probiotic
Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis
Intervention: Lactobacillus rhamnosus GG (Dietary Supplement)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported