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

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

Open access
Cohen, Craig R., Wierzbicki, Michael R., French, Audrey L., Morris, Sheldon, Newmann, Sara, Reno, Hilary, Green, Lauri, Miller, Steve +3 more·2020·New England Journal of Medicine

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.).

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1056/nejmoa1915254

Cites

45 of 45 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • 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)

    Experimental — accuracy not yet measured

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Cited by

Sorted by citations

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)
Venue
New England Journal of Medicine
Published
2020-05-14
Volume
382
Issue
20
Pages
1906-1915
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
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
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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review