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, Jacob D Estes, Jacob K Flynn, Amanda Loftin, Jason M Brenchley, Adriana Andrade, Douglas W Kitch, Edgar T Overton
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)...
December 2021: Open Forum Infectious Diseases