Trial reportThe New England journal of medicine2020
Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.
3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in The New England journal of medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 214 papers, 5 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
214citing papers in PubMed, 5 pooled it
27.8field-weighted citation impact, top 1% of its field
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.
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.
Phase II-b Randomized Double-Blind Placebo-Controlled Trial of Lactobacillus Crispatus CTV-05 (LACTIN-V) to Prevent the Recurrence of Bacterial Vaginosis
Phase 2 Placebo-controlled Randomized Trial of LACTIN-V (Lactobacillus Crispatus CTV-05) Among Women at High Risk of HIV Acquisition in Durban, South Africa
Modulation of Vaginal Microbiota by Lactobacillus Sp As a Probiotic and Immunomodulatory Agent in Postmenopausal Women with Bacterial Vaginosis
Who cites it
214 citing papers in PubMed, 5 syntheses or guidelines pooled it, 349 citations in OpenAlex.
- Role of probiotic as adjuvant in treating various infections: a systematic review and meta-analysis.BMC infectious diseases · 2024Pooled it
- Efficacy and safety of different drugs for the treatment of bacterial vaginosis: a systematic review and network meta-analysis.Frontiers in cellular and infection microbiology · 2024Pooled it
- Probiotics are a good choice for the treatment of bacterial vaginosis: a meta-analysis of randomized controlled trial.Reproductive health · 2022Pooled it
- Probiotics, a promising therapy to reduce the recurrence of bacterial vaginosis in women? a systematic review and meta-analysis of randomized controlled trials.Frontiers in nutrition · 2022Pooled it
- Sexually Transmitted Infections Treatment Guidelines, 2021.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021Guideline
- Clinical and vaginal microbiota effects of oral Lactobacillus crispatus M247 combined with vaginal laser therapy in menopausal women with atrophic vulvovaginitis: a prospective, randomized and controlled study.Lasers in medical science · 2026Trial
- Associations between Nugent-bacterial vaginosis and preterm birth and other adverse pregnancy outcomes in rural northwestern Bangladesh.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026Trial
- Vaginal microbiota impacts of a Lactobacillus crispatus live biotherapeutic and predictors of colonization in randomized controlled trial.Cell host & microbe · 2026Trial
- Impact of a multi-strain L. crispatus-based vaginal synbiotic on the vaginal microbiome: a randomized placebo-controlled trial.NPJ biofilms and microbiomes · 2025Trial
- Efficacy of clindamycin and LACTIN-V for in vitro fertilization patients with vaginal dysbiosis: a randomised double-blind, placebo-controlled multicentre trial.Nature communications · 2025Trial
- Trial
- Probiotics reduce the recurrence of asymptomatic bacterial vaginosis in Chinese women.Scientific reports · 2025Trial
- Trial
- Vaginal Bacteria and Proinflammatory Host Immune Mediators as Biomarkers of Human Immunodeficiency Virus Acquisition Risk Among African Women.The Journal of infectious diseases · 2024Trial
- Impact of antimicrobials on penile HIV susceptibility and immunology in uncircumcised men: A randomized phase 1/2 clinical trial.Cell reports. Medicine · 2024Trial
- VagiBIOM Lactobacillus suppository improves vaginal health index in perimenopausal women with bacterial vaginosis: a randomized control trial.Scientific reports · 2024Trial
- Intravaginal lactic acid gel versus oral metronidazole for treating women with recurrent bacterial vaginosis: the VITA randomised controlled trial.BMC women's health · 2023Trial
- Non-Lactobacillus-Dominant and Polymicrobial Vaginal Microbiomes Are More Common in Younger South African Women and Predictive of Increased Risk of Human Immunodeficiency Virus Acquisition.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Trial
- Improvement of vaginal probiotics Lactobacillus crispatus on intrauterine adhesion in mice model and in clinical practice.BMC microbiology · 2023Trial
- Postbiotic gel relieves clinical symptoms of bacterial vaginitis by regulating the vaginal microbiota.Frontiers in cellular and infection microbiology · 2023Trial
154 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
11 authors at 4 institutions in 1 country.
Craig R CohenFrom the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).ORCID 0000-0001-8654-6634
Michael R WierzbickiFrom the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).
Audrey L FrenchFrom the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).
Sheldon MorrisFrom the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).
Sara NewmannFrom the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).
Hilary RenoFrom the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).
Lauri GreenFrom the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).
Steve MillerFrom the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).
Jonathan PowellFrom the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).
Thomas ParksFrom the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).
Anke HemmerlingFrom the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).
University of California System · USRush University Medical Center · USUniversity of California, San Francisco · USWashington University in St. Louis · US
Funding
National Institute of Allergy and Infectious Diseases HHSN272201300014I/HHSN27200007NIAID NIH HHS HHSN272201300014I
Abstract
backgroundBacterial 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.
methodsWe conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of
resultsA total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit,
conclusionsThe 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.).
Indexed as
Administration, IntravaginalAdolescentAdultAnti-Bacterial AgentsAntibiosisDouble-Blind MethodFemaleGelsHumansIncidenceLactobacillus crispatusMetronidazoleMiddle AgedSecondary PreventionVaginaVaginosis, BacterialAnti-Bacterial AgentsGelsMetronidazole
Identifiers
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Registered trials
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.