Novel Way to Treat Resistant Vaginal Infections

Bacterial vaginosis (BV) is a common and undertreated condition. A disruption of the natural vaginal microbiome, BV is believed to afflict up to a third of women of reproductive age. Though often not serious unto itself,¹ BV can predispose a woman to an increased risk of upper genital-tract infections, greater susceptibility to sexually transmitted infections and pregnancy complications.² It is often characterized by a malodorous discharge.³

BV is usually treated with antibiotics but, as I have often pointed out in my newsletters, sometimes antibiotics can do more harm than good. In the case of BV, the harmful bacteria usually return after a round of antibiotics and, worse, the antibiotics invite other bacteria to overgrow.

Now comes news that the same restoration and repopulation of important microbiota that have been developed with "fecal transplants" may well be possible with BV. Recently published research suggests that transplants from those with healthy vaginal fluid, called microbiome transplantation (VMT), may help women suffering from these resistant vaginal infections.

A Technology Transferred From Intestinal Research

In recent years, scientists have discovered the microbes in our gut, collectively called our microbiome, can affect a lot more than digestion: They can affect mood,⁴ weight,⁵ asthma,⁶ acne, childhood disorders like ADHD,⁷ cardiovascular disease⁸ and, likely, our predisposition to disease.⁹

As scientists discovered the powerful and subtle workings of the gut microbiome, they also found it could be "reset" or repopulated with a fecal transplant from a healthy donor, in cases where it is not working properly.

This new technology of fecal transplants is especially impressive in helping to eradicate the tenacious and dangerous intestinal bacterium C. Difficile.¹⁰ Often gut microbiome impairment such as C. Difficile is caused by common pharmaceutical drugs like antibiotics and the overprescribed proton pump inhibitors.¹¹

Now the same methodology may help women suffering from BV. Like the intestinal microbiome, the vaginal microbiome seems to recognize and respond to the introduction of "good" bacteria, according to recent research. Both microbiomes are also affected by diet and lifestyle, though less research has been conducted with BV.

Slight Bodily Changes Can Cause BV

BV occurs when the vaginal microbiome becomes altered, resulting in a drop in Lactobacillus, a desirable bacterium, allowing other bacteria to take over and pH values to change.¹² Lactobacillus is desirable because it tends to have a higher lactic acid content and lowers alkaline levels.

In fact, physicians in the 1800s had already figured out that Lactobacillus could reduce the risk of vaginal microbiota sepsis that can occur post-childbirth, no doubt because of its acidic characteristics.¹³ This is how the BBC explains the inter-relationship:¹⁴

Experts know healthy microorganisms in the vagina prefer an acidic environment, and when the pH becomes too alkaline other bacteria — including those that cause BV — can thrive.

A number of factors can raise vaginal pH and make BV more likely, including having sex (semen and saliva are slightly alkaline) and using douches or vaginal washes, as well as hormonal changes at particular times of the month during a woman's menstrual cycle.

Laura Ensign, Ph.D., an investigator into the new vaginal fluid transplants, agrees:¹⁵ "In the vagina, the dominance of these lactobacillus bacteria keeps the vaginal pH acidic, and that's how you keep other [bad] bacteria out."

Promising New Research Is Good News for Women

Building on the success of fecal microbiota transplants to restore the gut microbiome, researchers at the Hebrew University Hadassah Medical Center and the Weizmann Institute of Science in Israel recently developed the first vaginal discharge transplant or vaginal microbiome transplantation (VMT). This is what the researchers, writing in Nature Medicine, report:¹⁶

"We report the results of a first exploratory study testing the use of vaginal microbiome transplantation (VMT) from healthy donors as a therapeutic alternative for patients suffering from symptomatic, intractable and recurrent bacterial vaginosis (ClinicalTrials.gov NCT02236429).

In our case series, five patients were treated, and in four of them VMT was associated with full long-term remission until the end of follow-up at 5–21 months after VMT, defined as marked improvement of symptoms, Amsel criteria, microscopic vaginal fluid appearance and reconstitution of a Lactobacillus-dominated vaginal microbiome.

One patient presented with incomplete remission in clinical and laboratory features. No adverse effects were observed in any of the five women. Notably, remission in three patients necessitated repeated VMT, including a donor change in one patient, to elicit a long-standing clinical response.

The therapeutic efficacy of VMT in women with intractable and recurrent bacterial vaginosis should be further determined in randomized, placebo- controlled clinical trials."

Encouraging Results in First Small Study

As the researchers write in Nature Medicine, two subjects in the study experienced remission immediately after VMT and two other subjects experienced remission when the VMT was repeated. A fifth subject experienced remission after changing to a new donor, suggesting that a donor match may be a contributory factor to a successful transplant. Dr. Ahinoam Lev-Sagie, one of the researchers in the Nature Medicine article, described the breakthrough in The Jerusalem Post:¹⁷

“We believe that testing larger VMT doses in future trials, or alternatively generating insights on donor selection, may enable [us] to optimize donor- recipient pairing and improve the chances of full success of this treatment. The results were amazing …

… Topics related to women's health have been often under-studied and even neglected in clinical medicine. Bacterial vaginosis, while not life-risking, is an exceedingly common female disorder that bears a severe toll on women's lives. I think it is amazing that we, as physicians, have the option to offer people something that can change their lives.”

The researchers are hoping to create a simple, standardized “microbial cocktail” that could be used with more BV sufferers and reduce the costs in providing a first treatment.

Strict Criteria for Vaginal Fluid Donors

Not just anyone can be a VMT donor, of course. A team of researchers at Johns Hopkins University that is also investigating vaginal microbiota transplants (VMT) points out that care must be taken in who would be appropriate donors for women suffering from BV and interested in such transplants.

The ideal donor, they say, would be asked to abstain from sex for at least a month before donating a sample and be screened for HIV and any other sexually transmitted infections to prevent them being passed on to a VMT recipient.¹⁸

The actual transplant process is not too complicated. According to BBC, the donor woman “inserts and removes a flexible plastic disc — similar to a menstrual cup or contraceptive diaphragm — to collect the sample.” Then the donated vaginal fluid “would be drawn into an applicator for the recipient to insert in a similar way to how a tampon.“

"The donation is a self collection, which we know people tend to prefer … It's quick and easy and one sample collected like that would be enough material to make one dose for transfer," Ensign said.

Vaginal Microbiota Transplants Will Also Help Self-Esteem

Aside from the risks for more serious conditions that BV poses, it also affects self-esteem. Here is how one woman describes her own case which led her to counsel others.¹⁹

"I'm 51 now, but in my 20s and 30s I suffered from infections over a 10-year period, before there were over-the-counter treatments. I was a nurse but I didn't have a clue about BV. I'd buy probiotic yoghurt from my local health store and whack that up there on a tampon, because I had this vague idea that it would restore [the bacteria], but that probably didn't do any good either …

… I do speak to women who are constantly getting it, going on antibiotics, getting thrush … Then they're desperate, and buying any old intimate hygiene product to get rid of the smell, which then exacerbates or masks the problem. This is really exciting research, and the transplants would be utterly amazing to help women break out of that cycle."

Until now, there have been few treatment options available for BV and those that exist are seldom fully curative or restorative. The ongoing research into the natural and drug-free vaginal microbiota transplants is encouraging for all women who suffer from BV.

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