Probiotic Lactobacillus GG to Eliminate VRE Colonization

This study has been terminated.
(Insufficient recruitment, no additional funding available)
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00756262
First received: September 19, 2008
Last updated: September 24, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


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 0,7,14,21,28,56 ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: March 2003
Study Completion Date: July 2012
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:
  • Lactobacillus GG (LGG)
  • Placebo is microcrystalline cellulose
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:
  • Lactobacillus GG (LGG)
  • Placebo is microcrystalline cellulose

  Eligibility

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

Inclusion Criteria:

  1. Age greater than or equal to 18 years
  2. Identified as having had a clinical isolate or stool or rectal swab culture positive for VRE
  3. Able to give informed consent and report on side effects
  4. Tolerating an oral/enteral diet
  5. Stable comorbid conditions
  6. Willing and able to come to Tufts for weekly visits
  7. Outpatient

Exclusion Criteria:

  1. Inpatients
  2. Active infection with VRE being treated
  3. Pregnancy
  4. Known use of LGG or another probiotic (not including yogurt) within the previous 30 days
  5. Presence of an active bowel leak, acute abdomen, active intestinal disease, or significant bowel dysfunction
  6. 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
  7. History of adverse reaction to product containing lactobacillus
  8. Active colitis (see definition below)
  9. Treatment with an antibiotic with activity against VRE
  10. Life expectancy less than one year or life-threatening condition
  11. Known or suspected allergies to probiotics, lactobacillus, milk protein, and microcrystalline cellulose
  12. Structural heart disease, history of endocarditis or valve replacement
  13. Positive baseline stool culture for LGG
  14. Recent or planned chemotherapy or radiation therapy
  15. Solid organ transplant within the prior year
  16. Stem cell transplant within the prior year
  17. 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]
  18. 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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: September 24, 2014
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 October 23, 2014