Evidence map›Paper›PMID 34888397›Full record

ArticleOpen forum infectious diseases2021

A Randomized, Placebo-Controlled Trial Assessing the Effect of VISBIOME ES Probiotic in People With HIV on Antiretroviral Therapy.

Rachel M Presti, Eunice Yeh, Brett Williams, Alan Landay, Jeffrey M Jacobson, Cara Wilson, Carl J Fichtenbaum, Netanya S Utay, Michael P Dube, Karin L Klingman and 7 more

Open access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.1field-weighted citation impact, top 23% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 16 citations in OpenAlex.

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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

17 authors at 11 institutions in 1 country.

Rachel M PrestiWashington University School of Medicine, St. Louis, Missouri, USA.ORCID https://orcid.org/0000-0002-5469-0727
Eunice YehHarvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
Brett WilliamsRush University Medical Center, Chicago, Illinois, USA.
Alan LandayRush University Medical Center, Chicago, Illinois, USA.
Jeffrey M JacobsonCase Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Cara WilsonUniversity of Colorado, Anschutz Medical Center, Aurora, Colorado, USA.
Carl J FichtenbaumUniversity of Cincinnati Medical Center, Cincinnati, Ohio, USA.
Netanya S UtayUniversity of Texas Southwestern Medical Center, Dallas, Texas, USA.
Michael P DubeUniversity of Southern California, Keck School of Medicine, Los Angeles, California, USA.
Karin L KlingmanMedical Science & Computing, Rockville, Maryland, USA.
Jacob D EstesVaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, Oregon, USA.
Jacob K FlynnBarrier Immunity Section, Lab of Viral Diseases, NIAID, NIH, Bethesda, Maryland, USA.
Amanda LoftinBarrier Immunity Section, Lab of Viral Diseases, NIAID, NIH, Bethesda, Maryland, USA.
Jason M BrenchleyBarrier Immunity Section, Lab of Viral Diseases, NIAID, NIH, Bethesda, Maryland, USA.
Adriana AndradeMedical Science & Computing, Rockville, Maryland, USA.
Douglas W KitchHarvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
Edgar T OvertonUniversity of Alabama at Birmingham, Birmingham, Alabama, USA.ORCID https://orcid.org/0000-0002-4013-536X
National Institute of Allergy and Infectious Diseases · USHarvard University · USRush University Medical Center · USOregon Health & Science University · USThe University of Texas Southwestern Medical Center · USUniversity of Alabama at Birmingham · USUniversity of Cincinnati · USUniversity of Colorado Anschutz Medical Campus · USUniversity of Southern California · USUniversity School · USWashington University in St. Louis · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Vanderbilt Institute for Clinical and Translational Research (VICTR) -Identifying correlates of functional immunity in SARS-CoV-2 convalescent plasmaUL1TR002243 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, Wesley H Self · 2017 to 2026
$130.7M
UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
Weill Cornell Medicine - Rutgers New Jersey Medical School Clinical Trials UnitUM1AI069419 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI ROY M. GULICK · 2012 to 2026
$44.6M
Case Clinical Trials Unit: Administrative Supplement NOSI AI-20-031.UM1AI069501 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI George Yendewa · 2012 to 2026
$40.4M
University of Pittsburgh Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SUSAN L KOLETAR, John W Mellors · 2012 to 2026
$38.0M
Vanderbilt HIV Clinical Trials Unit (CTU)UM1AI069439 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI David W Haas, Spyros A Kalams · 2012 to 2026
$33.1M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
A-Z Clinical Trials UnitUM1AI069452 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Paul A. Goepfert · 2012 to 2026
$28.8M
NCATS NIH HHS UL1 TR001881NCATS NIH HHS UL1 TR002243NIAID NIH HHS U01 AI069432NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069452NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

backgroundA5350, a phase II, randomized, double-blind study, evaluated the safety and tolerability of the probiotic Visbiome Extra Strength (ES) over 24 weeks and measured effects on inflammation and intestinal barrier function.

methodsThe primary outcome was change in soluble CD14 (sCD14) levels; secondary outcomes included safety and tolerability, markers of inflammation and cellular activation, and microbiome. In a substudy, gut permeability was assessed by paired colonic biopsies measuring the area of lamina propria occupied by CD4+ cells, interleukin (IL)-17+ cells, and myeloperoxidase (MPO). Changes between arms were compared with the 2-sample

resultsOverall, 93 participants enrolled: 86% male, median age 51 years, median CD4 count 712 cells/mm3. Visbiome ES was safe and well tolerated. There was no difference in mean change in sCD14 from baseline to week 25/26 between placebo (mean change, 92.3 µg/L; 95% CI, -48.5 to 233 µg/L) and Visbiome ES (mean change, 41.0 µg/L; 95% CI, -94.1 to 176.2 µg/L;

conclusionsVisbiome ES was safe and altered the microbiome but demonstrated no effect on systemic inflammatory markers, pathology, or gut permeability in antiretroviral therapy-treated people with HIV.

Indexed as

HIVhuman microbiomeinflammationprobiotics

Identifiers

PMID34888397
PMCPMC8651169
OpenAlexW4200551660

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.