van de Wijgert, Janneke HHM and Verwijs, Marijn C
(2020)
Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.
NEW ENGLAND JOURNAL OF MEDICINE, 383 (8).
pp. 790-791.
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Abstract
<h4>Background</h4>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.<h4>Methods</h4>We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of <i>Lactobacillus crispatus</i> 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.<h4>Results</h4>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, <i>L. crispatus</i> 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.<h4>Conclusions</h4>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.).
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Vagina, Humans, Vaginosis, Bacterial, Metronidazole, Gels, Anti-Bacterial Agents, Administration, Intravaginal, Incidence, Double-Blind Method, Antibiosis, Adolescent, Adult, Middle Aged, Female, Secondary Prevention, Young Adult, Lactobacillus crispatus |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 21 Sep 2020 07:37 |
| Last Modified: | 18 Mar 2024 04:23 |
| DOI: | 10.1056/nejmoa1915254 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3102026 |
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