The Influence of Probiotics on Vancomycin-Resistant Enterococcus

May 31, 2019 updated by: Robert Martindale, Oregon Health and Science University
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
VRE positive patients
Dietary supplement: probiotics
100 gms of a yogurt drink containing probiotics will be given to pVRE positive patients for 4 weeks
Placebo Comparator: 2
VRE positive patients
Dietary supplement: yogurt
100 gms of pasteurized yogurt drinks with no live cultures will be given to VRE positive patients for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Whether a positive VRE colonized patient becomes VRE negative after drinking yogurt with probiotics
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to VRE clearance
Time Frame: 4 weeks
4 weeks
Sustainable effects of probiotics on VRE colonization
Time Frame: 8 weeks
8 weeks
Any positive or negative effects on patients' hospital stay.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Robert Martindale, MD, PH.D, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

May 31, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB3848

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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