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Nation’s first vaginal fluid transplants offer hope for millions

Dr. Caroline Mitchell, center, and Dr. Agnes Bergerat watch as clinical research coordinator Briah Cooley processes a vaginal fluid donor sample to be stored and then given to people with recurrent BV at the Massachusetts General Hospital. (Jesse Costa/WBUR)
Dr. Caroline Mitchell, center, and Dr. Agnes Bergerat watch as clinical research coordinator Briah Cooley processes a vaginal fluid donor sample to be stored and then given to people with recurrent BV at the Massachusetts General Hospital. (Jesse Costa/WBUR)

Jade Genga has been grappling with vaginal discomfort and pain for years.

At first it seemed like just a nuisance. After her gynecologist diagnosed her with bacterial vaginosis — or BV — she took a course of antibiotics and things seemed better. But three weeks later, it was back. Another round of antibiotics helped, but only for four weeks. It came back again.

“I started to not like my own body because it was fighting me all the time,” said Genga, who is from Rhode Island.

She is far from alone. At any given moment, almost one in three women in the U.S. has BV, and the numbers are even higher for certain groups. More than 50% of African American women have the condition. BV has been linked to serious long-term health issues and yet, for many people, medicine does not have a good treatment.

But now there is new hope.

This summer Massachusetts General Hospital started performing the first vaginal fluid transplants in the U.S. After years of delays, the hope is that this study will offer insights that can help the estimated 21 million Americans, from teenagers to middle-aged women, who have BV.

‘Just so uncomfortable’

BV happens when the natural bacteria in a vagina get out of balance.

The experience can be different for different people. Indeed, most with BV report no symptoms. But for others, there can be discharge, odor and sometimes itching.

In Genga’s years-long attempt to get rid of BV, she tried medications, over-the-counter products, and holistic treatments. She’s tried changing her diet, her soap, her feminine products.

“I have tried everything,” she said. “And it’s just so uncomfortable.”

Her experience of having BV return just weeks after treatment is common. The standard medical treatment — antibiotics — has been unchanged for 40 years. Yet one month after taking antibiotics, there is a 40 to 60% chance the BV will have come back.

“The fact that there hasn’t been a new treatment is infuriating as a health care provider — and as a woman,” said Caroline Mitchell, director of the MGH’s Vulvovaginal Disorders Program.

Mitchell said her patients often describe antibiotics as temporary relief rather than a treatment. And the problem is deeper than the immediate discomfort. BV is associated with a host of serious health issues regardless of whether the person experiences any symptoms.

BV is linked to preterm birth. It’s linked to a higher risk of acquiring HIV or other sexually transmitted infections. It’s linked to the persistence of human papillomavirus and progression to cervical pre-cancer. It seems to be associated with infertility.

And it impacts more than just the individual.

“It really strikes at the core of their relationships. It makes them feel uncomfortable with intimacy with a partner. It makes them feel ashamed,” said Mitchell.

After years of failed treatments, one Sunday morning, Genga was so fed up with BV that she made herself a cup of tea and sat down at her computer. She spent the next several hours digging through medical journals to find some hint of hope. Eventually, she found what she was looking for.

The superhero bacterium

Genga stumbled across Mitchell’s lab, where after years of work and setbacks, Mitchell’s team was experimenting with vaginal fluid transplants.

The idea is simple: Take fluid from a happy vagina and put it in an unhappy one.

The science behind it is all about bacteria. Every person has trillions of bacteria living on and in their body. In most parts of the body, like the gut, having a lot of different types of bacteria is a good thing.

“But in the vagina, it’s really that simplicity is better,” said Mitchell.

What she wants to see under the microscope is just one type of bacterium dominating. It’s called Lactobacillus crispatus and some within the scientific community have nicknamed it the “superhero of the vagina.” It’s not the same lactobacilli in dairy products nor the one found it in the gut. Mitchell said the type found in the vagina is totally different and she credits it with creating this very stable, peaceful, calm environment in the vagina.”

Nobody really knows how the special power works. But Mitchell thinks it comes from the fact that this type of bacteria makes lactic acid which keeps the vagina relatively acidic. Scientists have discovered this environment is also correlated with less inflammation. When looking at HIV, researchers found that the virus moves more slowly in an acidic environment and, when there’s less inflammation, there are fewer targets for the virus.

But it’s been hard to study the superhero. As far as experts can tell, no animal — besides humans — has a vagina dominated by lactobacillus. Not baboons. Not chimpanzees. Not mice. And that makes it impossible to do animal studies to test things out before trying it in human subjects.

So, the work must happen in humans. Mitchell has a team of vaginal fluid donors who insert a menstrual cup at night and come by the lab in the morning to drop off the liquid that’s been collected. They are screened for all kinds of infections, can’t travel to places where the Zika virus is common, and must abstain from sex to avoid a stray sperm sneaking into the donation.

After months of painstakingly collecting the fluid — one tiny donation at a time — the actual transplant is easy. No operating room, no scalpels needed.

“We just use an eyedropper, and we do a speculum exam,” Mitchell said. “With the eyedropper, just put the fluid into the vagina. We have the person lay there for 15 minutes, and that’s it.”

The scientific community is watching to see if the superhero goes into action.

‘A new emerging field’

“I think this is a very interesting study. It’s a new emerging field,” said Anke Hemmerling, who is at the University of California, San Francisco, and not involved in Mitchell’s transplant study. Hemmerling’s own team is working on growing lactobacillus superheros in the lab and producing them as a powder for people to apply. So far, study results are promising.

She’s eager to see Mitchell’s results once the study concludes — as well as the findings from similar transplant studies in Denmark and Israel — but she worries the whole transplant approach is hard to standardize and too complicated logistically.

“You obviously have to check for a whole slew of different things,” she said. “You have to make sure that the donor sample is free of infectious diseases, that the woman doesn’t have a yeast infection, that the woman doesn’t have bacterial vaginosis.”

Plus, if it works, she said, what will the Food and Drug Administration think?

“Would they look at it as a drug? Would they look at it more along the lines of a tissue transplant or like a blood transfusion?” Hemmerling asked.

The answer, she said, is that nobody knows for sure and that could make approval of any product complicated.

Mitchell agrees. She said transplants likely aren’t the long-term, large-scale answer. Instead, she’s hopeful that by transplanting everything in the fluid it will show whether the superhero needs a side-kick — or two — to do its magic.

Any new products are still at least a few years away from being available to the general public. But Jade Genga didn’t have to wait.

After desperately poring over medical journals, she started reaching out to researchers. Recently, she got a call: She’d be the first patient in Mitchell’s transplant study.

“I actually burst into tears,” she recalled. “My boyfriend was like, ‘Are you OK? What is going on?’ ”

What was going on is that, for the first time in a long time, Genga felt hopeful about her own prognosis, even though neither she nor the scientists know yet whether the transplants will work. Still, Genga said, maybe one day others won’t have to go through the pain and embarrassment of bacterial vaginosis.

This article was originally published on WBUR.org.

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