GI Colonization of Vancomycin-resistant Enterococcus Clinical Trial
Official title:
The Influence of Probiotics on Vancomycin-Resistant Enterococcus
| NCT number | NCT00591474 |
| Other study ID # | IRB3848 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2007 |
| Est. completion date | June 2010 |
| Verified date | May 2019 |
| Source | Oregon Health and Science University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Drinking probiotics in a the form of a yogurt drink will restore normal gastrointestinal (GI) bacteria in patients whose colon are colonized with vancomycin-resistant enterococcus (VRE).
| Status | Terminated |
| Enrollment | 8 |
| Est. completion date | June 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - VRE positive patients with GI colonization Exclusion Criteria: - Age less than 18 years - Patients who have had a bone marrow transplant - Extreme short bowel patients (less than 100 cm small bowel remaining) - Patients with active VRE infection but no GI colonization - Patients unable to eat and have no feeding access - Patients who do not have a power of attorney to give consent if they are unable to |
| Country | Name | City | State |
|---|---|---|---|
| United States | OHSU hospital | Portland | Oregon |
| Lead Sponsor | Collaborator |
|---|---|
| Oregon Health and Science University |
United States,
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* Note: There are 40 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Whether a positive VRE colonized patient becomes VRE negative after drinking yogurt with probiotics | 4 weeks | ||
| Secondary | Time to VRE clearance | 4 weeks | ||
| Secondary | Sustainable effects of probiotics on VRE colonization | 8 weeks | ||
| Secondary | Any positive or negative effects on patients' hospital stay. | 8 weeks |