PMID- 34888397
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240404
IS  - 2328-8957 (Print)
IS  - 2328-8957 (Electronic)
IS  - 2328-8957 (Linking)
VI  - 8
IP  - 12
DP  - 2021 Dec
TI  - A Randomized, Placebo-Controlled Trial Assessing the Effect of VISBIOME ES 
      Probiotic in People With HIV on Antiretroviral Therapy.
PG  - ofab550
LID - 10.1093/ofid/ofab550 [doi]
LID - ofab550
AB  - BACKGROUND: A5350, 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. 
      METHODS: The 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 t test with equal variance or the Wilcoxon 
      rank-sum test. For safety, the highest graded adverse events (AEs) were compared 
      between arms using the Fisher exact test. RESULTS: Overall, 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 microg/L; 95% CI, 
      -48.5 to 233 microg/L) and Visbiome ES (mean change, 41.0 microg/L; 95% CI, -94.1 to 
      176.2 microg/L; P=.60). Similarly, no statistically significant differences between 
      arms in inflammatory marker changes were identified. In substudy participants, no 
      statistical differences between arms for change in cellular marker expression or 
      gut permeability were observed (P>.05 for all). The microbiome demonstrated 
      increased probiotic species and a significant decrease in Gammaproteobacteria 
      (P=.044) in the Visbiome ES arm. CONCLUSIONS: Visbiome 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.
CI  - (c) The Author(s) 2021. Published by Oxford University Press on behalf of 
      Infectious Diseases Society of America.
FAU - Presti, Rachel M
AU  - Presti RM
AUID- ORCID: 0000-0002-5469-0727
AD  - Washington University School of Medicine, St. Louis, Missouri, USA.
FAU - Yeh, Eunice
AU  - Yeh E
AD  - Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
FAU - Williams, Brett
AU  - Williams B
AD  - Rush University Medical Center, Chicago, Illinois, USA.
FAU - Landay, Alan
AU  - Landay A
AD  - Rush University Medical Center, Chicago, Illinois, USA.
FAU - Jacobson, Jeffrey M
AU  - Jacobson JM
AD  - Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
FAU - Wilson, Cara
AU  - Wilson C
AD  - University of Colorado, Anschutz Medical Center, Aurora, Colorado, USA.
FAU - Fichtenbaum, Carl J
AU  - Fichtenbaum CJ
AD  - University of Cincinnati Medical Center, Cincinnati, Ohio, USA.
FAU - Utay, Netanya S
AU  - Utay NS
AD  - University of Texas Southwestern Medical Center, Dallas, Texas, USA.
FAU - Dube, Michael P
AU  - Dube MP
AD  - University of Southern California, Keck School of Medicine, Los Angeles, 
      California, USA.
FAU - Klingman, Karin L
AU  - Klingman KL
AD  - Medical Science & Computing, Rockville, Maryland, USA.
FAU - Estes, Jacob D
AU  - Estes JD
AD  - Vaccine and Gene Therapy Institute, Oregon Health and Science University, 
      Portland, Oregon, USA.
FAU - Flynn, Jacob K
AU  - Flynn JK
AD  - Barrier Immunity Section, Lab of Viral Diseases, NIAID, NIH, Bethesda, Maryland, 
      USA.
FAU - Loftin, Amanda
AU  - Loftin A
AD  - Barrier Immunity Section, Lab of Viral Diseases, NIAID, NIH, Bethesda, Maryland, 
      USA.
FAU - Brenchley, Jason M
AU  - Brenchley JM
AD  - Barrier Immunity Section, Lab of Viral Diseases, NIAID, NIH, Bethesda, Maryland, 
      USA.
FAU - Andrade, Adriana
AU  - Andrade A
AD  - Medical Science & Computing, Rockville, Maryland, USA.
FAU - Kitch, Douglas W
AU  - Kitch DW
AD  - Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
FAU - Overton, Edgar T
AU  - Overton ET
AUID- ORCID: 0000-0002-4013-536X
AD  - University of Alabama at Birmingham, Birmingham, Alabama, USA.
LA  - eng
GR  - UM1 AI069494/AI/NIAID NIH HHS/United States
GR  - UM1 AI069501/AI/NIAID NIH HHS/United States
GR  - UM1 AI069432/AI/NIAID NIH HHS/United States
GR  - UM1 AI069439/AI/NIAID NIH HHS/United States
GR  - UM1 AI068634/AI/NIAID NIH HHS/United States
GR  - UM1 AI069481/AI/NIAID NIH HHS/United States
GR  - U01 AI069432/AI/NIAID NIH HHS/United States
GR  - UM1 AI106701/AI/NIAID NIH HHS/United States
GR  - UL1 TR002243/TR/NCATS NIH HHS/United States
GR  - UM1 AI069419/AI/NIAID NIH HHS/United States
GR  - UL1 TR001881/TR/NCATS NIH HHS/United States
GR  - UM1 AI068636/AI/NIAID NIH HHS/United States
GR  - UM1 AI069452/AI/NIAID NIH HHS/United States
GR  - UM1 AI069496/AI/NIAID NIH HHS/United States
PT  - Journal Article
DEP - 20211207
PL  - United States
TA  - Open Forum Infect Dis
JT  - Open forum infectious diseases
JID - 101637045
PMC - PMC8651169
OTO - NOTNLM
OT  - HIV
OT  - human microbiome
OT  - inflammation
OT  - probiotics
EDAT- 2021/12/11 06:00
MHDA- 2021/12/11 06:01
PMCR- 2021/12/07
CRDT- 2021/12/10 06:47
PHST- 2021/08/19 00:00 [received]
PHST- 2021/11/02 00:00 [accepted]
PHST- 2021/12/10 06:47 [entrez]
PHST- 2021/12/11 06:00 [pubmed]
PHST- 2021/12/11 06:01 [medline]
PHST- 2021/12/07 00:00 [pmc-release]
AID - ofab550 [pii]
AID - 10.1093/ofid/ofab550 [doi]
PST - epublish
SO  - Open Forum Infect Dis. 2021 Dec 7;8(12):ofab550. doi: 10.1093/ofid/ofab550. 
      eCollection 2021 Dec.