Probiotic Lactobacillus GG to Eliminate VRE Colonization
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Vancomycin Resistant Enterococcal Colonization
Intervention
Lactobacillus GG or Culturelle
Location
Tufts Medical Center-Division of Geographic Medicine and Infectious Diseases
Boston
Massachusetts
United States
02111
Status
Recruiting
Source
Tufts Medical Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00756262
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Vancomycin Resistance
Nonsusceptibility of bacteria to the action of VANCOMYCIN, an inhibitor of cell wall synthesis.
Tuberculosis, Multidrug-resistant
Tuberculosis resistant to chemotherapy with two or more ANTITUBERCULAR AGENTS, including at least ISONIAZID and RIFAMPICIN. The problem of resistance is particularly troublesome in tuberculous OPPORTUNISTIC INFECTIONS associated with HIV INFECTIONS. It requires the use of second line drugs which are more toxic than the first line regimens. TB with isolates that have developed further resistance to at least three of the six classes of second line drugs is defined as EXTENSIVELY DRUG-RESISTANT TUBERCULOSIS.
Extensively Drug-resistant Tuberculosis
Tuberculosis resistant to ISONIAZID and RIFAMPIN and at least three of the six main classes of second-line drugs (AMINOGLYCOSIDES; polypeptide agents; FLUOROQUINOLONES; THIOAMIDES; CYCLOSERINE; and PARA-AMINOSALICYLIC ACID) as defined by the CDC.
Lactobacillus Rhamnosus
A species of gram-positive, rod-shaped bacteria used in PROBIOTICS.
Lactobacillus Fermentum
A species of gram-positive, rod-shaped bacteria associated with DENTAL CARIES.
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