Journal Article

Randomized, Placebo-Controlled Phase 2 Trial of a <i>Lactobacillus crispatus</i> Probiotic Given Intravaginally for Prevention of Recurrent Urinary Tract Infection

Ann E. Stapleton, Melissa Au-Yeung, Thomas M. Hooton, David N. Fredricks, Pacita L. Roberts, Christopher A. Czaja, Yuliya Yarova-Yarovaya, Tina Fiedler, Marsha Cox and Walter E. Stamm

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 52, issue 10, pages 1212-1217
Published in print May 2011 | ISSN: 1058-4838
Published online May 2011 | e-ISSN: 1537-6591 | DOI: https://dx.doi.org/10.1093/cid/cir183
Randomized, Placebo-Controlled Phase 2 Trial of a Lactobacillus crispatus Probiotic Given Intravaginally for Prevention of Recurrent Urinary Tract Infection

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  • Infectious Diseases
  • Immunology
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  • Microbiology

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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 days, 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 (≥106 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.

Journal Article.  3756 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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