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Impact of Probiotics for Reducing Infections in Veterans: The IMPROVE Study

NCT01321606 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2018-08-03

Study results available
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Summary

The investigators have two hypotheses: (1) The probiotic L. rhamnosus HN001, when compared to placebo, will reduce S. aureus nasal colonization when taken for four weeks. (2) The probiotic L. rhamnosus HN001, when compared to placebo, will reduce S. aureus gastrointestinal colonization when taken for four weeks.

Conditions

  • Anti-biotic Resistance

Interventions

DIETARY_SUPPLEMENT

Lactobacillus rhamnosus HN001

Subjects will be given a pill formulation of a probiotic L. rhamnosus HN001 to be taken once a day, at a dose of 1 x 10\^10 organisms

DIETARY_SUPPLEMENT

sugar pill (placebo)

Placebo identical to the active product will be given

Sponsors & Collaborators

  • University of Wisconsin, Madison

    collaborator OTHER

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Nasia Safdar, MD PhD · William S. Middleton Memorial Veterans Hospital, Madison, WI

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01321606 on ClinicalTrials.gov