title: Phase 2a study assessing colonization efficiency, safety, and acceptability of Lactobacillus crispatus CTV-05 in women with bacterial vaginosis.
abstract: BACKGROUND
  Bacterial vaginosis (BV) is a common vaginal infection caused by a lack of endogenous lactobacilli and overgrowth of pathogens that frequently recurs following antibiotic treatment.
  
  
  METHODS
  A phase 2a study assessed colonization efficiency, safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) administered by a vaginal applicator. Twenty-four women with BV were randomized in a 3:1 ratio of active product to placebo. Participants used LACTIN-V at 2 × 10 colony-forming units (cfu)/dose or placebo for 5 initial consecutive days, followed by a weekly application over 2 weeks. They returned for follow-up on Days 10 and 28.
  
  
  RESULTS
  Sixty-one percent of the 18 women randomized to the LACTIN-V group were colonized with L. crispatus CTV-05 at Day 10 or Day 28. Among LACTIN-V users with complete adherence to the study regimen, 78% were colonized at Day 10 or Day 28. Of the 120 adverse events (AEs) that occurred, 108 (90%) and 12 (10%) were of mild and moderate severity, respectively. AEs were evenly distributed between the LACTIN-V and placebo group. Of the total AEs, 93 (78%) were genitourinary in origin. The most common genitourinary AEs included vaginal discharge (46%), abdominal pain (46%), dysuria (21%), pollakiuria (21%), vaginal odor (21%), and genital pruritus (17%). No grade 3 or 4 AEs or serious AEs occurred and no deep epithelial disruption was seen during colposcopic evaluation. The product was well tolerated and accepted.
  
  
  CONCLUSIONS
  LACTIN-V colonized well, and was safe and acceptable in women treated for BV.
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, CA 94105, USA. ahemmerling@globalhealth.ucsf.edu
authors.forename: Anke
authors.initials: A
authors.lastname: Hemmerling
authors.forename: William
authors.initials: W
authors.lastname: Harrison
authors.forename: Adrienne
authors.initials: A
authors.lastname: Schroeder
authors.forename: Jeanna
authors.initials: J
authors.lastname: Park
authors.forename: Abner
authors.initials: A
authors.lastname: Korn
authors.forename: Stephen
authors.initials: S
authors.lastname: Shiboski
authors.forename: Anne
authors.initials: A
authors.lastname: Foster-Rosales
authors.forename: Craig R
authors.initials: CR
authors.lastname: Cohen
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D015169:Colony Count, Microbial; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007778:Lactobacillus / Q000254:growth & development*; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects*; D055502:Secondary Prevention; D016896:Treatment Outcome; D014621:Vagina / Q000382:microbiology*; D016585:Vaginosis, Bacterial / Q000382:microbiology / Q000517:prevention & control*; D055815:Young Adult