Cited by 383Reproductive tract infections researchUrinary Tract Infections ManagementGynecological conditions and treatments

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Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

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Cohen, Craig R., Wierzbicki, Michael R., French, Audrey L., Morris, Sheldon, Newmann, Sara, Reno, Hilary, Green, Lauri, Miller, Steve, Powell, Jonathan, Parks, Thomas, Hemmerling, Anke·2020·New England Journal of Medicine

DOI 10.1056/nejmoa1915254PMC PMC7362958

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Abstract

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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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: Cohen, Craig R.
French, Audrey L.
Newmann, Sara
Reno, Hilary
Green, Lauri
Miller, Steve
Parks, Thomas
Hemmerling, Anke
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
DOI: 10.1056/nejmoa1915254
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
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
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 › Urology › 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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Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

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