NCT00933556

Brief Summary

The purpose of this study is to investigate the feasibility, safety and efficacy of oral probiotic, VSL#3 versus oral placebo for reducing colonization by VRE.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

July 2, 2009

Last Update Submit

October 6, 2015

Conditions

Anti-biotic Resistance

Keywords

infectionprobiotics

Outcome Measures

Primary Outcomes (1)

  • The main outcomes will be the proportion of patients colonized with VRE at 4 weeks, 8 weeks, 12 weeks and 24 weeks following start of treatment.

    24 weeks

Secondary Outcomes (1)

  • Incidence of clinical infections will be assessed in the one year following enrollment into the study.

    1 year

Study Arms (2)

probiotic

EXPERIMENTAL

subjects will be given a powder formulation of a probiotic VSL#3 to be taken once a day, at a dose of 6 gms

Dietary Supplement: VSL#3

sugar pill

PLACEBO COMPARATOR

placebo identical to the active product will be given

Dietary Supplement: sugar pill (placebo)

Interventions

VSL#3DIETARY_SUPPLEMENT

6 gms of powder formulation to be given once a day for 4 weeks

Also known as: yoplait, activia
probiotic
sugar pill (placebo)DIETARY_SUPPLEMENT

placebo identical to the active product will be given

Also known as: splenda
sugar pill

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects will be male or female
  • years of age or older
  • may or may not be hospitalized
  • able to take oral medications
  • have been found to be colonized with VRE or at high risk of being colonized by VRE and are not taking antibiotics

You may not qualify if:

  • people on antibiotics will not be eligible to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of wisconsin hospital

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Sugarstrichlorosucrose

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Nasia Safdar, MD, MS

    University of Wisconsin Department of Medicine (Infectious Disease)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 7, 2009

Study Start

October 1, 2008

Primary Completion

October 1, 2010

Study Completion

March 1, 2012

Last Updated

October 8, 2015

Record last verified: 2015-10

Locations

US(1)