The use of LGG will be associated with elimination of VRE colonization. The primary comparison will be VRE elimination rates among those patients that receive LGG compared to those that receive placebo. The primary endpoint will be the proportion of patients with VRE at one week after cessation of administration of study medication or placebo. The investigators assume that the placebo group will have very little spontaneous elimination of VRE and that the LGG group will be more likely to have eliminated VRE colonization at the end of one week.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
11
Drug to be administered orally (capsule form). Dose=2 capsules/day for 14 days. Dosage strength= 1x10\^10 bacteria
Tufts Medical Center-Division of Geographic Medicine and Infectious Diseases
Boston, Massachusetts, United States
The primary endpoint will be the proportion of patients with VRE at one week after cessation of administration of study medication or placebo.
Time frame: Day 21post enrollment
The rate of VRE colonization in LGG recipients versus controls at 2 weeks and 6 weeks post discontinuation of administration of LGG or placebo.
Time frame: 2 weeks, and 6 weeks
The rate of LGG colonization in study population receiving LGG compared to placebo.
Time frame: days 21, 28, 56
That LGG can be used safely and without significant side effects in both hospitalized and ambulatory patients.
Time frame: day 0-56 and 6 mnths
That among those treated with LGG, the colony counts of VRE will be lower when compared to controls even among those in whom colonization is not eliminated.
Time frame: day 0,7,14,21,28,56
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