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| ID | Type | Description | Link |
|---|---|---|---|
| 5 R 21 AT-001892 |
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Insufficient recruitment, no additional funding available
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Lactobacillus rhamnosus LGG |
|
| 2 | Placebo Comparator | Microcrystalline cellulose capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus GG or Culturelle | Biological | Drug to be administered orally (capsule form). Dose=2 capsules/day for 14 days. Dosage strength= 1x10^10 bacteria |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint will be the proportion of patients with VRE at one week after cessation of administration of study medication or placebo. | Day 21post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of VRE colonization in LGG recipients versus controls at 2 weeks and 6 weeks post discontinuation of administration of LGG or placebo. | 2 weeks, and 6 weeks | |
| The rate of LGG colonization in study population receiving LGG compared to placebo. |
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Inclusion Criteria:
Exclusion Criteria:
Colitis will be defined as a history of Crohn's disease or ulcerative colitis with active diarrhea, active diarrhea due to Clostridium difficile infection, active diarrhea due to known or unknown cause with a stool specimen showing fecal leukocytes (if none has been done in such a patient this will be requested prior to enrollment). Diarrhea will be defined as more than three unformed bowel movements per day. The subject's primary physician will be asked to assess the subject's life expectancy, and subjects with an estimated life expectancy of less than one year as judged by the physician who knows him or her best will be excluded.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center-Division of Geographic Medicine and Infectious Diseases | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26014940 | Result | Doron S, Hibberd PL, Goldin B, Thorpe C, McDermott L, Snydman DR. Effect of Lactobacillus rhamnosus GG Administration on Vancomycin-Resistant Enterococcus Colonization in Adults with Comorbidities. Antimicrob Agents Chemother. 2015 Aug;59(8):4593-9. doi: 10.1128/AAC.00300-15. Epub 2015 May 26. |
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| days 21, 28, 56 |
| That LGG can be used safely and without significant side effects in both hospitalized and ambulatory patients. | 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. | day 0,7,14,21,28,56 |