Evidence map›Paper›PMID 35659905›Full record

Trial reportThe Lancet. Microbe2022

Sustained effect of LACTIN-V (Lactobacillus crispatus CTV-05) on genital immunology following standard bacterial vaginosis treatment: results from a randomised, placebo-controlled trial.

Eric Armstrong, Anke Hemmerling, Steve Miller, Kerianne E Burke, Sara J Newmann, Sheldon R Morris, Hilary Reno, Sanja Huibner, Maria Kulikova, Nico Nagelkerke and 3 more

Erratum issuedOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Microbe, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 60 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 1 pooled it
9.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.

  1. Pooled it
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  14. HIV Transmission and Immunology of the Male Reproductive Tract.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026
    Review
  15. The Gut-Vagina Axis.Microorganisms · 2026
    Review
  16. Article
  17. Innate Immunity and Microbial Recognition in Reproduction: From Barrier Defense to Maternal-Fetal Tolerance.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
    Review
  18. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 2 countries.

Eric ArmstrongDepartment of Medicine, University of Toronto, Toronto, ON, Canada. Electronic address: ericm.armstrong@mail.utoronto.ca.
Anke HemmerlingDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, CA, USA.
Steve MillerDepartment of Laboratory Medicine, University of California, San Francisco, CA, USA.
Kerianne E BurkeRuth M Rothstein CORE Centre, John H Stroger Jr Hospital of Cook County, Chicago, IL, USA.
Sara J NewmannDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, CA, USA.
Sheldon R MorrisDepartment of Family Medicine and Public Health, University of California, San Diego, CA, USA.
Hilary RenoDepartment of Medicine, Washington University, St Louis, MO, USA.
Sanja HuibnerDepartment of Medicine, University of Toronto, Toronto, ON, Canada.
Maria KulikovaToronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada.
Nico NagelkerkeCentre for Global Health Research, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.
Bryan CoburnDepartment of Medicine, University of Toronto, Toronto, ON, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada; Department of Immunology, University of Toronto, Toronto, ON, Canada; Toronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada; Department of Medicine, University Health Network, Toronto, ON, Canada.
Craig R CohenDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, CA, USA.
Rupert KaulDepartment of Medicine, University of Toronto, Toronto, ON, Canada; Department of Immunology, University of Toronto, Toronto, ON, Canada; Department of Medicine, University Health Network, Toronto, ON, Canada.
University of California, San Francisco · USUniversity of Toronto · CAToronto General Hospital · CAJohn H. Stroger, Jr. Hospital of Cook County · USSt. Michael's Hospital · CAUniversity of California, San Diego · USWashington University in St. Louis · US

Funding

CIHR PJT-156123NIAID NIH HHS HHSN272201300011CNIAID NIH HHS HHSN272201300014CNIAID NIH HHS HHSN272201300014I
6 · The paper itself

Abstract

backgroundBacterial vaginosis might increase HIV risk by eliciting genital inflammation and epithelial barrier disruption, whereas vaginal Lactobacillus crispatus is associated with immune quiescence and HIV protection. We investigated the effect of a live biotherapeutic containing L crispatus CTV-05 (LACTIN-V) on genital immunology and key vaginal bacteria.

methodsThis substudy included women aged 18-45 years who participated in the randomised, placebo-controlled, phase 2b trial of LACTIN-V to reduce bacterial vaginosis recurrence, conducted at four universities and hospitals in the USA. Women with negative results for sexually transmitted infection, pregnancy, and urinary tract infection were provided a 5-day course of vaginal metronidazole 0·75% gel. Those who met at least three of four clinical Amsel criteria for bacterial vaginosis and had a Nugent score of 4-10 from Gram staining were eligible. Participants in the LACTIN-V trial were randomly assigned (2:1) to receive either LACTIN-V or placebo, applied vaginally once per day for 5 days during the first week and then twice per week for 10 more weeks. Follow-up visits occurred 4, 8, 12, and 24 weeks after enrolment. Soluble immune factors and the absolute abundance of bacterial taxa were assayed by mutliplex ELISA and quantitative PCR. The primary outcomes were vaginal levels of IL-1α and soluble E-cadherin at 24 weeks (ie, 13 weeks after treatment cessation).

findingsBetween Feb 21, 2020 and March 18, 2021, we characterised genital immune parameters and the vaginal microbiota in a subset of 66 highly adherent participants who were randomly selected, with no exclusion criteria, from those who had attended all study follow-up visits (n=166) in the larger LACTIN-V clinical trial (n=288). 32 (48%) participants received LACTIN-V and 34 (52%) received placebo. LACTIN-V treatment was significantly associated with lower concentrations of the proinflammatory cytokine IL-1α (β coefficient 0·310, SE 0·149; p=0·042) and soluble E-cadherin (0·429, 0·199; p=0·035), a biomarker of epithelial barrier disruption.

interpretationVaginal administration of LACTIN-V following standard bacterial vaginosis therapy resulted in a sustained reduction in genital inflammation and a biomarker of epithelial integrity. The potential of LACTIN-V to reduce HIV susceptibility merits further investigation.

fundingCanadian Institutes of Health Research and the National Institutes of Health National Institute of Allergy and Infectious Diseases.

Indexed as

HIV InfectionsLactobacillus crispatusVaginosis, BacterialBacteriaCadherinsCanadaFemaleHumansInflammationMetronidazoleUnited StatesVaginaCadherinsMetronidazole

Identifiers

PMID35659905
PMCPMC9188188
OpenAlexW4224304689

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.