title: Randomized controlled trial of strain-specific probiotic formulation (Renadyl) in dialysis patients.
abstract: BACKGROUND
  Primary goal of this randomized, double-blind, placebo-controlled crossover study of Renadyl in end-stage renal disease patients was to assess the safety and efficacy of Renadyl measured through improvement in quality of life or reduction in levels of known uremic toxins. Secondary goal was to investigate the effects on several biomarkers of inflammation and oxidative stress.
  
  
  METHODS
  Two 2-month treatment periods separated by 2-month washout and crossover, with physical examinations, venous blood testing, and quality of life questionnaires completed at each visit. Data were analyzed with SAS V9.2.
  
  
  RESULTS
  22 subjects (79%) completed the study. Observed trends were as follows (none reaching statistical significance): decline in WBC count (-0.51 × 10(9)/L, P = 0.057) and reductions in levels of C-reactive protein (-8.61 mg/L, P = 0.071) and total indoxyl glucuronide (-0.11 mg%, P = 0.058). No statistically significant changes were observed in other uremic toxin levels or measures of QOL.
  
  
  CONCLUSIONS
  Renadyl appeared to be safe to administer to ESRD patients on hemodialysis. Stability in QOL assessment is an encouraging result for a patient cohort in such advanced stage of kidney disease. Efficacy could not be confirmed definitively, primarily due to small sample size and low statistical power-further studies are warranted.
authors.affiliation: Kibow Biotech, Inc., 4781 West Chester Pike, Newtown Square, PA 19073, USA.
authors.forename: Ranganathan
authors.initials: R
authors.lastname: Natarajan
authors.affiliation: Kibow Biotech, Inc., 4781 West Chester Pike, Newtown Square, PA 19073, USA.
authors.forename: Bohdan
authors.identifier: 0000-0002-6961-5885
authors.initials: B
authors.lastname: Pechenyak
authors.affiliation: Kibow Biotech, Inc., 4781 West Chester Pike, Newtown Square, PA 19073, USA.
authors.forename: Usha
authors.identifier: 0000-0002-1860-9872
authors.initials: U
authors.lastname: Vyas
authors.affiliation: Kibow Biotech, Inc., 4781 West Chester Pike, Newtown Square, PA 19073, USA.
authors.forename: Pari
authors.identifier: 0000-0002-0530-9045
authors.initials: P
authors.lastname: Ranganathan
authors.affiliation: Mount Sinai School of Medicine, New York, NY 10029, USA.
authors.forename: Alan
authors.identifier: 0000-0002-1312-2897
authors.initials: A
authors.lastname: Weinberg
authors.affiliation: Downstate Medical Center, State University of NY, New York, NY 11203, USA.
authors.forename: Peter
authors.identifier: 0000-0003-3672-9293
authors.initials: P
authors.lastname: Liang
authors.affiliation: Downstate Medical Center, State University of NY, New York, NY 11203, USA.
authors.forename: Mary C
authors.initials: MC
authors.lastname: Mallappallil
authors.affiliation: Downstate Medical Center, State University of NY, New York, NY 11203, USA.
authors.forename: Allen J
authors.initials: AJ
authors.lastname: Norin
authors.affiliation: Downstate Medical Center, State University of NY, New York, NY 11203, USA.
authors.forename: Eli A
authors.initials: EA
authors.lastname: Friedman
authors.affiliation: Downstate Medical Center, State University of NY, New York, NY 11203, USA.
authors.forename: Subodh J
authors.initials: SJ
authors.lastname: Saggi
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000378:metabolism; D002097:C-Reactive Protein / Q000378:metabolism; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007249:Inflammation / Q000378:metabolism; D007676:Kidney Failure, Chronic / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D018384:Oxidative Stress / Q000502:physiology; D019936:Probiotics / Q000378:metabolism*; D011788:Quality of Life; D006435:Renal Dialysis / Q000379:methods
chemical_list: D015415:Biomarkers; D002097:C-Reactive Protein