126. Robust and Persistent Vaginal Colonization with LACTIN-V Vaginal Lactobacillus crispatus Probiotic in a Double-Blind, Placebo Controlled (DBPC) Phase 2b Trial to Prevent Recurrent UTI (rUTI)
Session: Oral Abstract Session: What's Hot in UTIs and STIs
Thursday, October 4, 2018: 9:15 AM
Room: S 158
Background: We investigated vaginal colonization using repetitive sequence PCR (repPCR) and 16S rRNA sequencing in a Phase 2b DBPC trial of a L. crispatus intravaginal suppository probiotic for prevention of rUTI in pre-menopausal women.

Methods: 24 young women with a history of rUTI and current culture-confirmed symptomatic UTI were enrolled and treated (Visit 0), then randomized (Visit 1) to receive an intravaginal suppository containing L. crispatus CTV-05 (LACTIN-V®, Osel, Inc.) or placebo daily for 5 days, then once weekly for two months. Participants were followed during the 2-month probiotic/placebo intervention (Visits 2 to 4; active intervention) and during 2 months following the intervention (Visits 5 and 6; post-intervention). At each visit, vaginal swabs were collected for repPCR to determine the presence or absence of the probiotic strain and the duration of its presence in the vagina and for 16S rRNA-based sequence analysis to determine relative abundance of any L. crispatus.

Results:

LACTIN-V vaginal suppository induced selective and sustained colonization in the probiotic but not the placebo recipients, as follows:

Pre-intervention

  • Probiotic lactobacillus strain
    • Not found in vaginal specimens obtained from participants in either arm of study

Active intervention

  • Probiotic lactobacillus strain
    • Probiotic arm: 100% of participants positive at one or more visits
    • Placebo arm: 0% of participants positive at any time
  • L. crispatus relative abundance
    • Probiotic arm: above 90%, all specimens, all visits
    • Placebo arm: below 15%, all specimens, all visits

Post-intervention

  • Probiotic lactobacillus strain
    • Probiotic arm: 75% of participants positive at Visit 5, 58% at Visit 6
    • Placebo arm: 0% of participants positive at Visits 5 and 6.
  • L. crispatus relative abundance
    • Probiotic arm: 70% to 100%
    • Placebo arm: below 15%

Conclusion: LACTIN-V L. crispatus vaginal probiotic achieved robust and persistent colonization throughout two months of weekly dosing and for two months after the last dose in most participants.

Ann Stapleton, MD, FIDSA1, Aurelio Silvestroni, PhD1, Pacita Roberts, MS2, Marsha Cox, MS2, Hillary Hayden, PhD2, Mitchell Brittnacher, PhD2, Samuel Miller, MD1 and Thomas Hooton, MD, FIDSA3, (1)Medicine, University of Washington, Seattle, WA, (2)University of Washington, Seattle, WA, (3)Medicine, University of Miami, Miami, FL

Disclosures:

A. Stapleton, None

A. Silvestroni, None

P. Roberts, None

M. Cox, None

H. Hayden, None

M. Brittnacher, None

S. Miller, None

T. Hooton, None

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