Randomized, Placebo-Controlled Phase 2 Trial of a Lactobacillus crispatus Probiotic Given Intravaginally for Prevention of Recurrent Urinary Tract Infection
Open accessAbstract
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 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.
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Lower lactobacilli levels promote bacterial vaginosis or vaginal E. coli colonization, which increases the risk of UTI recurrence.
“Therefore, lower lactobacilli levels promote bacterial vaginosis or vaginal E. coli colonization, which increases the risk of UTI recurrence [1, 14, 34, 35].”
Several recent clinical studies have demonstrated that topical Lactobacillus therapy as 'complementary treatment' after antibiotic therapy, especially with vaginal suppositories, can significantly reduce the frequency of rUTIs, even in postmenopausal women with refractory infections.
“Several recent clinical studies have demonstrated that topical Lactobacillus therapy as 'complementary treatment' after antibiotic therapy, especially with vaginal suppositories, can significantly reduce the frequency of rUTIs, even in postmenopausal women with refractory infections [6, 14-16], highlighting the therapeutic potential of microbiome-targeted strategies.”
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- Authors
- Stapleton, A. E., Au-Yeung, M., Hooton, T. M., Fredricks, D. N., Roberts, P. L., Czaja, C. A., Yarova-Yarovaya, Y., Fiedler, T., Cox, M., & Stamm, W. E.
- Affiliations
- University of Washington (US)
- University of Miami (US)
- Fred Hutch Cancer Center (US)
- National Jewish Health (US)
- Venue
- Clinical Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2011-05-15
- Volume
- 52
- Issue
- 10
- Pages
- 1212-1217
- ISSN
- 1058-4838 (ISSN-L)
- 1537-6591
- PMC
- PMC3079401
- OpenAlex
- W2154916375
- Cited by
- 484
- References
- 1
- Citations by year
- 2026: 36 · 2025: 32 · 2024: 38 · 2023: 43 · 2022: 45 · 2021: 32 · 2020: 34 · 2019: 22 · 2018: 26 · 2017: 32 · 2016: 37 · 2015: 23 · 2014: 21 · 2013: 23 · 2012: 28
- FWCI
- 19.80
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Clinical Infectious Diseases (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- University of Washington
- National Institute of Diabetes and Digestive and Kidney Diseases (P01DK053369, P50DK064540, R01DK088830, R01DK070906)
- Topics
- Health Sciences › Medicine › Epidemiology › Urinary Tract Infections Management
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Keywords
- recurrent urinary tract infection, Lactobacillus crispatus, probiotics, vaginal lactobacilli, vaginal colonization, cystitis, premenopausal women, urinary tract infection prevention, 16S rRNA gene quantification
- MeSH terms
- Administration, Intravaginal, Adolescent, Adult, Double-Blind Method, Female, Humans, Lactobacillus, Placebos, Recurrence, RNA, Ribosomal, 16S, Urinary Tract Infections, Urine, Vagina, Polymerase Chain Reaction, Treatment Outcome, Probiotics, Young Adult, Bacterial Load
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