Evidence map›Paper›PMID 27836508›Full record

Trial reportContemporary clinical trials2017

Impact of Probiotics for Reducing Infections in Veterans (IMPROVE): Study protocol for a double-blind, randomized controlled trial to reduce carriage of Staphylococcus aureus.

Shoshannah Eggers, Anna Barker, Susan Valentine, Timothy Hess, Megan Duster, Nasia Safdar

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01321606 (IMpact of PRObiotics for Reducing Infections in VEterans), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01321606 phase2completednot on this map

IMpact of PRObiotics for Reducing Infections in VEterans: The IMPROVE Study

TypeinterventionalSponsorVA Office of Research and DevelopmentRan2011 to 2015Enrolled113ConditionsAnti-biotic ResistanceArmsLactobacillus rhamnosus HN001, sugar pill (placebo)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Shoshannah EggersWilliam S. Middleton Memorial Veterans Affairs Medical Center, Department of Medicine, Madison, WI, USA; University of Wisconsin-Madison School of Medicine and Public Health, Madison, WI, USA; Department of Population Health Sciences, University of Wisconsin - Madison School of Medicine and Public Health, Madison, WI, USA.
Anna BarkerDepartment of Population Health Sciences, University of Wisconsin - Madison School of Medicine and Public Health, Madison, WI, USA.
Susan ValentineWilliam S. Middleton Memorial Veterans Affairs Medical Center, Department of Medicine, Madison, WI, USA.
Timothy HessWilliam S. Middleton Memorial Veterans Affairs Medical Center, Department of Medicine, Madison, WI, USA; University of Wisconsin-Madison School of Medicine and Public Health, Madison, WI, USA.
Megan DusterUniversity of Wisconsin-Madison School of Medicine and Public Health, Madison, WI, USA.
Nasia SafdarWilliam S. Middleton Memorial Veterans Affairs Medical Center, Department of Medicine, Madison, WI, USA; Department of Population Health Sciences, University of Wisconsin - Madison School of Medicine and Public Health, Madison, WI, USA; University of Wisconsin Hospitals and Clinics, Madison, WI, USA. Electronic address: nasia.safdar@va.gov.
University of Wisconsin–Madison · USWilliam S. Middleton Memorial Veterans Hospital · US

Funding

Institutional Clinical and Translational Science AwardUL1TR000427 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2012 to 2016
$32.2M
INTEGRATED TRAINING FOR PHYSICIAN-SCIENTISTST32GM008692 · NIGMS · UNIVERSITY OF WISCONSIN-MADISON · PI BURKARD, MARK E · 1998 to 2020
$10.3M
Institutional Clinical and Translational Science AwardTL1TR000429 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2012 to 2016
$1.5M
IMpact of PRObiotics for reducing infections in VEterans: The IMPROVE StudyI01CX000391 · VA · WM S. MIDDLETON MEMORIAL VETERANS HOSP · PI SAFDAR, NASIA · 2012 to 2016
–
CSRD VA I01 CX000391NCATS NIH HHS TL1 TR000429NCATS NIH HHS UL1 TR000427NIGMS NIH HHS T32 GM008692
6 · The paper itself

Abstract

backgroundStaphylococcus aureus (S. aureus) is an organism of great public health importance, causing 20,000 deaths annually. Decolonization of patients with S. aureus may prevent infections, yet current options are limited to antimicrobials that promote antibiotic resistance and can cause adverse side effects. Probiotics have potential to reduce colonization of pathogenic bacteria, representing a promising alternative for S. aureus decolonization, but thus far lack rigorous evaluation.

methodsPotential subjects were recruited from inpatient and outpatient settings within a VA medical center and screened for S. aureus gastrointestinal (GI) or extra-GI colonization using swabs at multiple body sites. Positive, eligible, consenting participants were stratified by colonization site and randomized in a 1:1 ratio to 4-weeks of daily placebo or Lactobacillus rhamnosus (L. rhamnosus) HN001 probiotic treatment. Blood and stool samples, and treatment adherence reports were collected from each subject throughout the study, along with a final set of swabs at study completion to detect S. aureus carriage. The outcomes of this study are GI or extra-GI carriage by S. aureus at the end of 4weeks of therapy, change in phagocytic activity of polymorphonuclear cells from pre-intervention to post-intervention, and symptomatic S. aureus infection at any site during the study period.

conclusion114 participants have been recruited for this study. Analysis of outcomes is underway. This is the first clinical trial to examine the efficacy of L. rhamnosus HN001 for decolonization of S. aureus, and investigates the mechanism by which L. rhamnosus HN001 mediates its effect on S. aureus colonization. ClinicalTrials.govIdentifier NCT01321606.

Indexed as

Lacticaseibacillus rhamnosusCarrier StateDouble-Blind MethodHumansProbioticsStaphylococcal InfectionsStaphylococcus aureusUnited StatesUnited States Department of Veterans AffairsVeteransClinical trialLactobacilliMRSAProbioticsStaphylococcus aureusVeterans

Identifiers

PMID27836508
PMCPMC5670736
OpenAlexW2554693655

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.