Probiotic Lactobacillus GG to Eliminate VRE Colonization
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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 |
Biological: Lactobacillus GG or Culturelle |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Probiotic Lactobacillus GG to Eliminate VRE Colonization |
- 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 ]
- 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 0,7,14,21,28,56 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 38 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | July 2013 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Lactobacillus rhamnosus LGG
|
Biological: Lactobacillus GG or Culturelle
Drug to be administered orally (capsule form). Dose=2 capsules/day for 14 days. Dosage strength= 1x10^10 bacteria
Other Names:
|
|
Placebo Comparator: 2
Microcrystalline cellulose capsules
|
Biological: Lactobacillus GG or Culturelle
Drug to be administered orally (capsule form). Dose=2 capsules/day for 14 days. Dosage strength= 1x10^10 bacteria
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- 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
- Active colitis (see definition below)
- Treatment with an antibiotic with activity against VRE
- Life expectancy less than one year or life-threatening condition
- Known or suspected allergies to probiotics, lactobacillus, milk protein, and microcrystalline cellulose
- Structural heart disease, history of endocarditis or valve replacement
- Positive baseline stool culture for LGG
- Recent or planned chemotherapy or radiation therapy
- Solid organ transplant within the prior year
- Stem cell transplant within the prior year
- On active immunosuppressive medication [anti-rejection, injectable immunosuppressive drugs for autoimmune disease, or corticosteroids (greater than 1/2 mg per kg body weight of prednisone or its equivalent) not including inhaled or topical steroids]
- Allergy or intolerance to or contraindication to two or more of the rescue antibiotic regimens (ampicillin, clindamycin, moxifloxacin)
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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More Information
No publications provided
| Responsible Party: | Tufts Medical Center |
| ClinicalTrials.gov Identifier: | NCT00756262 History of Changes |
| Other Study ID Numbers: | 6283, 5 R 21 AT-001892 |
| Study First Received: | September 19, 2008 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Tufts Medical Center:
|
Vancomycin Resistant enterococcal colonization Probiotics LGG Lactobacillus rhamnosus |
ClinicalTrials.gov processed this record on May 16, 2013