Probiotic Lactobacillus GG to Eliminate VRE Colonization
Stopped: Insufficient recruitment, no additional funding available
United States11 participantsStarted 2003-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age greater than or equal to 18 years
✓. Identified as having had a clinical isolate or stool or rectal swab culture positive for VRE
✓. Able to give informed consent and report on side effects
✓. Tolerating an oral/enteral diet
✓. Stable comorbid conditions
✓. Willing and able to come to Tufts for weekly visits
✓. Outpatient
Exclusion criteria
✕. Inpatients
✕. Active infection with VRE being treated
✕. Pregnancy
✕. Known use of LGG or another probiotic (not including yogurt) within the previous 30 days
✕
What they're measuring
1
The primary endpoint will be the proportion of patients with VRE at one week after cessation of administration of study medication or placebo.
. Presence of an active bowel leak, acute abdomen, active intestinal disease, or significant bowel dysfunction
✕. Presence of an absolute neutrophil count less than 500 per cubic mm or anticipation post chemotherapy that the absolute neutrophil count will fall below 500 per cubic mm
✕. History of adverse reaction to product containing lactobacillus