title: A Randomized, Double-Blind, Parallel-Group, Multicenter Clinical Study of Escherichia coli-Lyophilized Lysate for the Prophylaxis of Recurrent Uncomplicated Urinary Tract Infections.
abstract: BACKGROUND
  One strategy for managing recurrent uncomplicated urinary tract infections (UTIs) is prevention. This study tested OM-89S, a lyophilized lysate of 18 Escherichia coli strains manufactured using a modified lytic process.
  
  
  METHODS
  This was a randomized, double-blind trial in 451 female subjects with recurrent uncomplicated UTIs. Period 1 of the study tested 6 mg of OM-89S versus placebo (3 months), plus a 3-month observation. Period 2 of the study was a 3-month treatment period (each monthly cycle consisted of 6 mg of OM-89S daily for 10 days and placebo for 20 days, vs. 50 mg nitrofurantoin daily for 30 days), plus a 3-month observation.
  
  
  RESULTS
  There was no difference in the mean rate of UTI episodes between the OM-89S (0.66 ± 0.93) and placebo groups (0.63 ± 0.86; p = 0.95) in period 1. Similar findings were obtained for period 2. OM-89S was well-tolerated.
  
  
  CONCLUSIONS
  Our results did not demonstrate a preventive effect of OM-89S compared to placebo. This may be due to the low number of UTIs that occurred during the study, the high number of protocol violations, and/or the modified manufacturing process used for OM-89S.
authors.affiliation: Clinic for Urology, Pediatric Urology and Andrology, Justus-Liebig University, Giessen, Germany.
authors.forename: Florian M E
authors.initials: FM
authors.lastname: Wagenlehner
authors.forename: Stefania
authors.initials: S
authors.lastname: Ballarini
authors.forename: Adrian
authors.initials: A
authors.lastname: Pilatz
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Weidner
authors.forename: Lorenz
authors.initials: L
authors.lastname: Lehr
authors.forename: Kurt G
authors.initials: KG
authors.lastname: Naber
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D004926:Escherichia coli / Q000737:chemistry*; D004927:Escherichia coli Infections / Q000188:drug therapy; D005060:Europe; D005260:Female; D005612:Freeze Drying; D006801:Humans; D008875:Middle Aged; D009582:Nitrofurantoin / Q000627:therapeutic use; D012008:Recurrence; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000188:drug therapy* / Q000517:prevention & control*
chemical_list: D000900:Anti-Bacterial Agents; D009582:Nitrofurantoin