Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis
Open accessAbstract
BACKGROUND: Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis. METHODS: CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12. RESULTS: CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups. CONCLUSIONS: The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).
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A study of vaginally administered Lactobacillus crispatus CTV-05 strain LACTIN-V demonstrated reduced BV recurrence at 24 weeks from 54% to 39%.
“A recent study of vaginally administered biotherapeutic Lactobacillus crispatus CTV-05 strain LACTIN-V, demonstrated reduced BV recurrence at 24 weeks from 54% to 39% [31].”
From Feasibility, safety and tolerability of estrogen and/or probiotics for improving vaginal health in Canadian African, Caribbean, and Black women: A pilot phase 1 clinical trial (2025) · cites this paper as [31]
The Methods describe vaginally administered Lactin-V, and the Abstract Results report a lower risk of BV recurrence by week 24 than with placebo (risk ratio 0.73). The passages in our copy do not give the claimed week-24 recurrence rates of 54% and 39%, so those exact percentages cannot be verified. (LLM, conf=0.86)
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- Authors
- Cohen, C. R., Wierzbicki, M. R., French, A. L., Morris, S., Newmann, S., Reno, H., Green, L., Miller, S., Powell, J., Parks, T., & Hemmerling, A.
- Affiliations
- University of California, San Francisco (US)
- Rush University Medical Center (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2020-05-14
- Volume
- 382
- Issue
- 20
- Pages
- 1906-1915
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC7362958
- OpenAlex
- W3024851520
- Cited by
- 377
- References
- 45
- Citations by year
- 2026: 71 · 2025: 70 · 2024: 55 · 2023: 60 · 2022: 47 · 2021: 52 · 2020: 22
- FWCI
- 33.29
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- National Institute of Allergy and Infectious Diseases (HHSN272201300014I/HHSN27200007)
- Topics
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Health Sciences › Medicine › Epidemiology › Urinary Tract Infections Management
- Health Sciences › Medicine › Obstetrics and Gynecology › Gynecological conditions and treatments
- Keywords
- bacterial vaginosis, recurrence prevention, vaginal probiotics, Lactobacillus, metronidazole, vaginal treatment, adverse events
- MeSH terms
- Lactobacillus crispatus, Administration, Intravaginal, Adolescent, Adult, Antibiosis, Anti-Bacterial Agents, Double-Blind Method, Female, Gels, Humans, Metronidazole, Middle Aged, Vagina, Incidence, Vaginosis, Bacterial, Secondary Prevention, Young Adult
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