Probiotic Lactobacillus GG to Eliminate VRE Colonization - Full Text View

Sponsored by:	Tufts Medical Center
Information provided by:	Tufts Medical Center
ClinicalTrials.gov Identifier:	NCT00756262

Purpose

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.

Condition	Intervention	Phase
Vancomycin Resistant Enterococcal Colonization	Dietary Supplement: Lactobacillus GG or Culturelle	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Probiotic Lactobacillus GG to Eliminate VRE Colonization

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
The rate of LGG colonization in study population receiving LGG compared to placebo. [ Time Frame: days 21, 28, 56 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 0,3,7,14,21,28,56 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	March 2003
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Lactobacillus rhamnosus LGG	Dietary Supplement: Lactobacillus GG or Culturelle Drug to be administered orally (capsule form). Dose=2 capsules/day for 14 days. Dosage strength= 1x10^10 bacteria
2: Placebo Comparator Microcrystalline cellulose capsules	Dietary Supplement: Lactobacillus GG or Culturelle Drug to be administered orally (capsule form). Dose=2 capsules/day for 14 days. Dosage strength= 1x10^10 bacteria

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Exclusion Criteria:

Patients in an intensive care unit
Active infection with VRE being treated
Pregnancy
Known use of LGG or another probiotic (not including yogurt) within the previous 30 days
Presence of an active bowel leak or acute abdomen
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
Active colitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756262

Locations

United States, Massachusetts
Tufts Medical Center-Division of Geographic Medicine and Infectious Diseases
Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

Tufts Medical Center

More Information

No publications provided

Responsible Party:	Tufts Medical Center ( David R. Snydman, M.D. )
Study ID Numbers:	6283, 5 R 21 AT-001892
Study First Received:	September 19, 2008
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00756262 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tufts Medical Center:

Vancomycin Resistant enterococcal colonization
Probiotics
LGG
Lactobacillus rhamnosus

Study placed in the following topic categories:

Vancomycin

ClinicalTrials.gov processed this record on May 07, 2009