L. crispatus decreases bacterial vaginosis recurrence after treatment with metronidazole
Using Lactobacillus crispatus CTV-05, or Lactin-V, after treatment with vaginal metronidazole lowers the rate of bacterial vaginosis recurrence in women, according to a study published in The New England Journal of Medicine.
“I think that there is promise that Lactin-V will be available as adjuvant therapy, along with antibiotic treatment, to reduce women's risk for recurrence of bacterial vaginosis, which clinicians who take care of women with vaginal discharge know is a very common problem that women of reproductive age in particular suffer from,” Craig R. Cohen, MD, MPH, professor in the department of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, told Healio.
Cohen and colleagues performed a randomized, double-blind phase 2b trial in 228 women aged 18 to 45 years who had received a diagnosis of bacterial vaginosis and had completed a course of vaginal metronidazole gel. They assigned women in a 2:1 ratio to receive Lactin-V via vaginal administration (n = 152) or placebo (n = 76) for 11 weeks, with follow-up through week 24. The primary outcome was the percentage of patients with a recurrence of bacterial vaginosis by week 12.
“Something that was important for many of the women in the trial is that it is a naturally occurring product,” Cohen said. “It's derived from women with an optimal vaginal microbiome.”
Most women (88% administered Lactin-V and 84% who received placebo) could be evaluated for the primary outcome. Recurrence of bacterial vaginosis occurred in 46 (30%) of the women given Lactin-V and in 34 (45%) of women given a placebo (RR after multiple imputation for missing responses = 0.66; 95% CI, 0.44-0.87). The risk ratio for recurrence by week 24, which was also calculated with multiple imputation for missing responses, was 0.73 (95% CI, 0.54-0.92). Researchers detected Lactin-V at week 12 in 79% of the participants who were administered the treatment.
Adverse events related to Lactin-V or the placebo by week 24 did not differ significantly between groups. In addition, the percentage of participants with systematic or local adverse events was similar among both groups.
Cohen noted that further research into how bacterial vaginosis may influence other sequelae and conditions is important, as well as improving the number of participants who remain adherent to the study protocol during the next phase of the trial. He also emphasized the importance of selecting a diverse patient population.
“We are committed as a research team, and the company as well, to ensuring that we test this product in an ethnically and racially diverse population in the United States,” he said. “This includes women who identify as African American, Hispanic and Latina, including those who come from a lower socioeconomic status. We want to make it feasible and easy for women who come from a variety of backgrounds to join the trial.” – by Eamon Dreisbach
Disclosure: Cohen reports receiving one-time speakers’ honoraria from Lupin Pharmaceuticals and Miyarisan Pharmaceuticals. Please see the study for all other authors’ relevant financial disclosures.
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