The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria

Washington University School of Medicine103 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

103

Conditions

Infectious Disease of Digestive Tract

Interventions

Lactobacillus rhamnosus GGDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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

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.

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)

Data from ClinicalTrials.gov

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