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Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.
N Engl J Med. 2020 05 14; 382(20):1906-1915.NEJM

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

We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus 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

A 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, L. crispatus 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.).

Authors+Show Affiliations

From 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.).From 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.).From 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.).From 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.).From 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.).From 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.).From 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.).From 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.).From 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.).From 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.).From 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.).

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

32402161

Citation

Cohen, Craig R., et al. "Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis." The New England Journal of Medicine, vol. 382, no. 20, 2020, pp. 1906-1915.
Cohen CR, Wierzbicki MR, French AL, et al. Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis. N Engl J Med. 2020;382(20):1906-1915.
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. (2020). Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis. The New England Journal of Medicine, 382(20), 1906-1915. https://doi.org/10.1056/NEJMoa1915254
Cohen CR, et al. Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis. N Engl J Med. 2020 05 14;382(20):1906-1915. PubMed PMID: 32402161.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis. AU - Cohen,Craig R, AU - Wierzbicki,Michael R, AU - French,Audrey L, AU - Morris,Sheldon, AU - Newmann,Sara, AU - Reno,Hilary, AU - Green,Lauri, AU - Miller,Steve, AU - Powell,Jonathan, AU - Parks,Thomas, AU - Hemmerling,Anke, PY - 2020/5/14/entrez PY - 2020/5/14/pubmed PY - 2020/5/23/medline SP - 1906 EP - 1915 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 382 IS - 20 N2 - 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: We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus 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: A 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, L. crispatus 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.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/32402161/Randomized_Trial_of_Lactin-V_to_Prevent_Recurrence_of_Bacterial_Vaginosis L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa1915254?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -