Clinical trial NCT00591474: The Influence of Probiotics on Vancomycin-Resistant Enterococcus
Official title: The Influence of Probiotics on Vancomycin-Resistant Enterococcus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: GI Colonization of Vancomycin-resistant Enterococcus
Keywords: VRE
Probiotics
colonization
gut health
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Whether a positive VRE colonized patient becomes VRE negative after drinking yogurt with probiotics
timeFrame: 4 weeks
Secondary outcomes:
measure: Time to VRE clearance
timeFrame: 4 weeks
measure: Sustainable effects of probiotics on VRE colonization
timeFrame: 8 weeks
measure: Any positive or negative effects on patients' hospital stay.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU hospital
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Robert Martindale, MD, PH.D
role: PRINCIPAL_INVESTIGATOR
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