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Vaginal microbial transplantation: The next frontier in women’s health?

Article-Vaginal microbial transplantation: The next frontier in women’s health?

© AdobeStock/motortion Vaginal microbial transplantation: The next frontier in women’s health?
With parallels to faecal microbiota transplantation (FMT), used to address certain intestinal conditions, the promise of vaginal microbial transplantation (VMT) is creating commercial possibilities, piquing the interest of startups in the emerging vaginal health and fertility space.

VMT or vaginal seeding is the idea that an unbalanced bacterial environment can be repopulated using fluid taken from someone with a healthy vaginal microbiome.

The procedure may be especially useful for caesarean-born infants, whose microbiome differs from vaginally delivered infants and who have increased disease risks. Others who may benefit include those with bacterial vaginosis (BV).

Companies in the intimate health space include US-based Evvy and Stix, which both offer a range of testing kits and products that address this neglected and misunderstood area of women’s health.

Tiny Health: VMT ‘shows potential’

Tiny Health, a startup based in Austin, Texas, also offers at-home gut health testing for babies and mums, and believes that while VMT shows potential, it is too early to position the procedure as a service or product for mothers-to-be.

“It is premature to say definitively,” said the Tiny Health team, made up of Cheryl Sew Hoy, CEO and founder; Noel Mueller, Tiny Health’s scientific advisor and adjunct professor at Johns Hopkins University; and Mariya Petrova, Tiny Health vaginal microbiome expert and board member of Women and their Microbes.

“The literature is still mixed and there’s not yet any long-term outcome data. Many organisations don’t want to risk lawsuits so they are not formally recommending it yet.

“We are excited about the possibility of a more formally approved VMT plan, which is foreseeable in the near future. We would also push for the best evidence and larger randomised controlled trials (RCTs) with long-term safety outcome data.”

Evidence for VMT’s effectiveness is inconclusive

It is admittedly early days for VMT scientifically, with only a few studies following a 2016 pilot study. These include the UK Baby Biome study and an RCT, which both offer limited, if any, efficacy.

But in equal measure, the vaginal microbiome is having a moment, with the birth of these startups coupled with the recent development of a “vagina on a chip” to better understand vaginal health.

Tiny Health pointed out that apart from the mother’s vaginal microbiome, her gut microbiota also plays a crucial role in the initial baby gut colonisation, so VMT alone may not be sufficient to restore baby gut microbiota in caesarean-delivered infants.

Companies interested in taking this science forward would also need to weigh up some important concerns before VMT could be considered a bona fide therapeutic procedure.

One key consideration is that VMT from mother to infant versus VMT from women to women with BV is slightly different and has different risk factors or considerations.

For vaginal seeding at birth, there is the mother’s existing health conditions to factor in, which play a role in priming the baby’s immune system via her gut microbes.

“A mum who has diabetes or is obese may prime a baby’s immune system differently from a mum who doesn’t have those conditions,” explained Tiny Health.

“So, when considering VMT at birth, it depends if it will be from the birth mum to baby or a donor mum to baby.”

Infection an important consideration when performing VMT

In lessons learnt from the advent of FMT, infections could be a big concern when considering VMTs, particularly HPV infections, with researchers reporting that just one person out of 20 tested negative for HPV.

“It is also easy to miss HPV because it sheds its genetic material intermittently, which means that a donor can test negative on one day but test positive on another,” said Tiny Health. “It could be unsafe if the virus is shedding when the transplant donation is collected.”

And, of course, cost is one major consideration, where using VMT to address gut dysbiosis may involve some kind of personalisation that would make the procedure unviable or expensive in the long run.

© AdobeStock/Clayton D/ The next frontier in women’s health?

However, Tiny Health doesn’t necessarily agree, highlighting that microbiome test usage to individually screen VMT candidates would not be cost prohibitive as sequencing costs are decreasing, thus becoming more affordable.

“Overall, VMTs wouldn’t be that expensive since it should be a one-time thing. Compare this to ongoing probiotics or other treatment with a monthly cost that comes with the inconvenience of ongoing care and management,” said Tiny Health.

“For VMTs in the case of a caesarean-born baby, there is also the concept of seeding baby with the right microbes during a critical time window.

“Primordial prevention (course-correcting before the condition occurs) is worth much more than treating the conditions later.”

For now, the approach is one to keep an eye on, especially as the gut microbiome is generating huge amounts of interest.

The concept of microbial transplantation as a potential therapy is indeed on the horizon, but its possibilities must be supported by credible evidence before any commercial progress can be made.

“In short, you really have to think about VMT or FMT differently based on the condition you’re trying to treat,” said Tiny Health. “And generally, the science needs to catch up before we start using VMT or FMT more formally.”