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Clinical Trial
. 2020 May 14;382(20):1906-1915.
doi: 10.1056/NEJMoa1915254.

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

Craig R Cohen  1 , Michael R Wierzbicki  1 , Audrey L French  1 , Sheldon Morris  1 , Sara Newmann  1 , Hilary Reno  1 , Lauri Green  1 , Steve Miller  1 , Jonathan Powell  1 , Thomas Parks  1 , Anke Hemmerling  1
Affiliations
Clinical Trial

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

Craig R Cohen et al. N Engl J Med. .

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.).

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Figures

Figure 1.
Figure 1.
Enrollment, Randomization, and Follow-up.
Figure 2.
Figure 2.. Median Concentration and Incidence of Detectable Lactobacillus crispatus CTV-05 in the Lactin-V Group, According to Trial Visit.
I bars indicate maximum and minimum values, the horizontal lines inside the blue bars indicate median values, and the diamonds indicate mean values. (The circles below the blue bar at week 4 represent outliers.) The size of each blue bar represents the interquartile range. CFU denotes colony-forming units.
Figure 3.
Figure 3.. Solicited Local (Genitourinary) Adverse Events, According to Treatment Group.
No severe solicited local adverse events were reported in either group.
See this image and copyright information in PMC

Comment in

References

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    1. Cohen CR, Lingappa JR, Baeten JM, et al. Bacterial vaginosis associated with increased risk of female-to-male HIV-1 transmission: a prospective cohort analysis among African couples. PLoS Med 2012; 9(6): e1001251. - PMC - PubMed
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