Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tufts Medical Center
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Probiotic Lactobacillus GG to Eliminate VRE Colonization
