Microbiome therapy protects against recurrent bacterial vaginosis
A product containing healthy vaginal bacteria has proved effective against recurrent bacterial vaginosis (BV), an extremely common vaginal infection that is associated with preterm birth, HIV infection and problems with in vitro fertilization. BV is one of the most frequent bacterial infections, affecting nearly 30 percent of women of reproductive age in the United States, and anywhere from 15 to 50 percent of women around the world. It is associated with the spread of HIV in Africa, where women make up the majority of those infected, as well as preterm birth and low-birth weight around the world. Additionally, there is a high recurrence rate, suggesting the need for new treatments.
New research from Bixby members highlights results from a clinical trial of LACTIN-V, a so-called “live biotherapeutic” that contains a common bacterium found in healthy vaginal microbiomes. The trial showed a significant reduction in the recurrence of BV and found no safety risks from the bacteria used in the LACTIN-V formulation.
While BV is commonly treated with an antibiotic called metronidazole, up to three-quarters of women get the infection again within three months. The study found that LACTIN-V reduced these recurrences significantly. Just 30 percent of women who were given LACTIN-V after initial antibiotic treatment had a recurrence within 12 weeks, compared to 45 percent of the women who received the antibiotic treatment and no LACTIN-V. The 228 women in the trial used LACTIN-V once a day for five days, and then twice a week for 10 weeks. LACTIN-V comes in a powder form that women self-administer with a vaginal applicator. Researchers said the product’s ease of use could make it an ideal medication for women around the world.
“The initial indication for LACTIN-V is for the prevention of BV, which millions of women in the U.S. have each year,” said first author Craig Cohen. “But this product also has the potential to be an effective intervention to prevent HIV infection and preterm birth.” Before LACTIN-V can be used, however, the U.S. Food and Drug Administration (FDA) is likely to require a successful next phase trial with more participants.
“This is an entirely new approach that strengthens the vaginal microbiome against infections,” said Anke Hemmerling, “This could be a breakthrough for the long-term prevention of BV.”