Innovation

Vaginal Fluid Transplants In The US: What You Need To Know

Researchers at the Johns Hopkins University have conducted the first trial of vaginal microbiota transplantation (VMT) ever known. The initiative was recently made possible after the Food and Drug Administration (FDA) approved the medical research guidelines that need to be followed to find curative treatment for bacterial vaginosis (BV).  

Bacterial vaginosis is the most common vaginal infection affecting pre-menopausal and sexually active women between the ages of 15 to 44. The risk factors are having multiple sexual partners or vaginal douching, which both disturb the balance of vaginal microbiota.

Sometimes, BV just disappears on its own without displaying any symptoms such as a gray or white vaginal discharge, pain, itching or burning in and around the vaginal area. Current treatment is limited to antibiotics that reduces the risk of contracting sexually transmitted diseases. Unfortunately, there is no definite assurance with antibiotics since BV can still return several times. 

The study published in Frontiers in Cellular and Infection Microbiology tested the transplantation of vaginal fluids from healthy women to those diagnosed with BV. They tried to develop a process in which the donors could be screened for healthy microbes and to ensure that the vaginal fluid does not contain pathogens. 

The success of fecal microbiota transplant (FMT) in the gut, where majority of the microbes reside, has helped treat gut dysbiosis by restoring bacterial diversity. Scientists are exploring the use of FMT to treat bowel disease, multiple sclerosis, liver disease, depression and more. Similarly, this has motivated researchers to study transplantation of fluids dominated by Lactobacillus crispatus bacteria into the vagina. 

In the gut, the bacteria has to remain diverse in order to maintain good health but not in the case of the vagina. This fact that the loss of dominance in Lactobacillus leads to diversity in the vaginal bacteria then causes BV has been known since the 1800s. The epidemiological evidence of the vaginal exchange is plenty, especially between women having sex with other women. 

“But before clinical trials of VMT are conducted, we must first determine how to screen donors to find those with minimal risk of transmissible pathogens, and optimal vaginal microbiota for transplant," Dr. Ethel Weld, study co-author, said. 

vagina Researchers at the Johns Hopkins University have established universal screening procedure to identify 'super donors' for vaginal microbiota transplantation (VMT). Photo courtesy of Shutterstock

Screening Process Established

In the pilot study, 20 women aged 23-35 were subjected to a screening procedure involving a questionnaire as well as medical tests to find eligible VMT donors. Blood, urine, vaginal swabs and fluid levels were analyzed to find exposure to STIs, vaginal bacteria and other potential infections. The motive was to weed out unhealthy vaginal bacteria samples with these cheap but reliable medical tests. 

"Based on our exclusion criteria, 7/20 (35%) of these participants might be eligible VMT donors. But the actual success rate for participation as a VMT donor in a clinical trial will likely be much lower still," Dr. Laura Ensign, another study co-author, said.

However, grading lactobacillus bacteria and conducting more detailed confirmatory tests could only happen at a later stage when they could already identify more promising donors. Nonetheless, this study shares some insights such as vaginal fluids dominated by Lactobacillus crispatus tend to have lower pH levels and higher protective lactic acid, which is the ideal environment for them to survive.  

Researchers realized that such a donor who ticks all the boxes was rare to find, hence they are on the lookout for a 'super donor'. "Once a safe donor has been identified using this protocol, she could donate on multiple appropriately screened occasions; the idea of a 'super-donor' with no identified past or current infections and with favorable Lactobacillus-dominated microbiota is one that should be explored," Ensign explained. 

There are certain limitations. More diversity is needed with the participants since most of the them were White and East Asian women. Invasive screening procedures could deter some women as well. Hence, this exclusive number of super donors have to be willing to donate on their own despite the intensive screening they have to endure. However, the researchers remain hopeful. 

"We anticipate that the trajectory of VMT will likely follow that of fecal transplantation, with efforts to cultivate uniform, standardized transplants that have similar therapeutic efficacy to donor material,” Ensign added. 

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