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Randomized, placebo-controlled phase 2 trial of a Lactobacillus crispatus probiotic given intravaginally for prevention of recurrent urinary tract infection.

  • 2011-05-15
  • Clinical Infectious Diseases 52(10)
    • A. Stapleton
    • Melissa Au-Yeung
    • T. Hooton
    • D. Fredricks
    • P. Roberts
    • C. Czaja
    • Yuliya Yarova-Yarovaya
    • T. Fiedler
    • Marsha E Cox
    • W. Stamm

Abstract

Background: Urinary tract infections (UTIs) are common among women and frequently recur. Depletion of vaginal lactobacilli is associated with UTI risk, which suggests that repletion may be beneficial. We conducted a double-blind placebo-controlled trial of a Lactobacillus crispatus intravaginal suppository probiotic (Lactin-V; Osel) for prevention of recurrent UTI in premenopausal women.

Methods: One hundred young women with a history of recurrent UTI received antimicrobials for acute UTI and then were randomized to receive either Lactin-V or placebo daily for 5 d, then once weekly for 10 weeks. Participants were followed up at 1 week and 10 weeks after intervention and for UTIs; urine samples for culture and vaginal swabs for real-time quantitative 16S ribosomal RNA gene polymerase chain reaction for L. crispatus were collected.

Results: Recurrent UTI occurred in 7/48 15% of women receiving Lactin-V compared with 13/48 27% of women receiving placebo (relative risk [RR], .5; 95% confidence interval, .2-1.2). High-level vaginal colonization with L. crispatus (≥10(6) 16S RNA gene copies per swab) throughout follow-up was associated with a significant reduction in recurrent UTI only for Lactin-V (RR for Lactin-V, .07; RR for placebo, 1.1; P < .01).

Conclusions: Lactin-V after treatment for cystitis is associated with a reduction in recurrent UTI. Larger efficacy trials of this novel preventive method for recurrent UTI are warranted. CLINICAL TRIALS REGISTRATION. NCT00305227.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Lactobacillus crispatusReduced Recurrent Urinary Tract InfectionsBeneficial
Moderate
Lactobacillus crispatus LBV 88Reduced Recurrent Urinary Tract InfectionsBeneficial
Moderate
Lactobacillus crispatus LBV88Increased Vaginal Colonization with Lactobacillus crispatusBeneficial
Large
Lactobacillus crispatus LBV88Reduced Recurrent Urinary Tract InfectionsBeneficial
Moderate
Lactobacillus crispatus LCr86Reduced Recurrence of Urinary Tract InfectionsBeneficial
Large
Lactobacillus crispatus LCr86Reduced Recurrent UTIBeneficial
Moderate
Lactobacillus crispatus LV5 88Increased Vaginal Colonization with Lactobacillus crispatusBeneficial
Large
Lactobacillus crispatus LV5 88Reduced Recurrent UTIBeneficial
Moderate
Lactobacillus crispatus UALcr-35Reduced Recurrent Urinary Tract InfectionsBeneficial
Moderate
Lactobacillus crispatus VPro 31Reduced Recurrent Urinary Tract InfectionsBeneficial
Moderate
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