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Microbiome therapy protects against recurrent bacterial vaginosis.

Bacterial vaginosis (BV) is a commonly occurring bacterial infection affecting approximately thirty percent of women of reproductive age in the United States. BV is linked to the spread of HIV in Africa, problems with in vitro fertilization, as well as preterm birth and low-birth-weight around the world. Risk factors for BV can include sexual activity, the use of an IUD, or using perfumed-based products on or around the vagina. The current treatment for BV is antibiotics, however, there is a recurrence rate of 15-30% in the three months after treatment, with multiple outbreaks of BV possible after this period of time. Now, a study from researchers at UC San Diego develops a treatment containing healthy vaginal bacteria, in effect a ‘live biotherapeutic’, that successfully treated BV and stopped it from recurring in the 3-month ‘danger window’ after recovery. The team states their new, more natural approach, strengthens the vaginal microbiome against infections, proffering a breakthrough in the long-term prevention of BV. The study is published in the NEJM.

Previous studies show BV is a common condition caused by an overgrowth of naturally-occurring microbiota in the vagina. This in turn causes a change in the vagina’s natural pH resulting in abnormal vaginal discharge, which may become thicker, more abundant, or develop an unpleasant smell. BV is not a sexually-transmitted disease, however, it can occur after intercourse, and if you have a same-sex female partner they may also need treatment. The gold-standard treatment for BV is an antibiotic called metronidazole with many women acquiring the infection again within only three months. Therefore, a gentle long-term solution is highly desired here. The current study develops a vaginal microbiota implant to treat BV in women.

The current study trials a naturally occurring microbe in the vagina called Lactobacillus crispatus CTV-05 (LACTIN-V) converted into a convenient powder form women can self-administer using a vaginal applicator. The clinical trial involved two hundred and twenty-eight women aged between 18-45 years of age who had completed a course of metronidazole after being diagnosed with BV. One-hundred and fifty-two participants used LACTIN-V once a day for 5 days, and then twice a week for 10 weeks, while the 76 remaining participants were placed in the placebo group. Results show only thirty percent of women given LACTIN-V after initial antibiotic treatment had a recurrence of BV within 12 weeks, compared to 45 percent of the women who received the antibiotic and a placebo.

The lab explains their therapy works by colonizing the vagina to produce lactic acid, which in turn, inhibits the growth of the bacteria associated with BV. They go on to add their biotherapeutic can be stored for more than a year at room temperature, and will remain stable for two years whilst refrigerated. They conclude the use of LACTIN-V in BV produces a significant reduction in the recurrence of BV without causing any adverse events.

The team surmises they have developed a vaginal bacterial implant capable of lowering the recurrence of BV up to 12 weeks after treatment with antibiotics. For the future, the researchers state before LACTIN-V can be marketed the U.S. FDA will require a successful Phase III trial involving more participants.

Source: ScienceDaily

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