US doctors have received permission to & # 39; vaginal bacterial transplants & # 39; to be tested in women with bacterial vaginosis (BV).
Researchers at John Hopkins University in Baltimore are planning to take vaginal fluid from healthy donors.
The & # 39; good bacteria & # 39; of the donors are placed in a tampon-like device and tested in a trial with approximately 40 BV patients, some with vaginal microbiotransplantation (VMT) and others with a placebo.
The US Food and Drug Administration approved the trial after the doctors had used vaginal fluid from 20 volunteers in a pilot study.
The doctors claim that & # 39; unsuitable & # 39; donors can be easily & # 39; screened & # 39 ;, with further testing than determining their & # 39; bacterial quality & # 39 ;.
The unusual approach, inspired by faecal transplants, would be a & # 39; fully curative or convalescent & # 39; Being able to offer BV therapy. The condition is currently being treated with antibiotics, but often comes back within three months.
It is unclear when the process will begin. The doctors said they would start & # 39; immediately & # 39; if they had the necessary financing.
US doctors have received permission to & # 39; vaginal bacterial transplants & # 39; to be tested in women with bacterial vaginosis. This happens when there is a shift in the balance of vaginal bacteria (stock)
BV occurs when there is a shift to the natural balance of bacteria in the vagina. This can be due to diet, medication, the menstrual cycle or showering.
Although the symptoms are less than half the time, BV can cause an unusual discharge with a strong fish odor.
Long-term BV has even been associated with cervical cancer, as well as premature birth and miscarriage in pregnant women.
The doctors were inspired by the success of faecal transplants, where healthy stools are transplanted into the gastrointestinal tract of C.difficile patients.
Although it may sound nauseous, the procedure has been shown to be successful in up to 92 percent of recurrent infections that do not respond to antibiotics.
& # 39; We expect that the VMT trajectory is likely to follow that of fecal transplantation, with efforts to cultivate uniform, standardized transplants that have similar therapeutic efficacy to donor material, & # 39; said study author Dr. Laura Ensign.
Although a wide range of bacteria is crucial for good intestinal health, Lactobacillus should dominate the vagina to prevent BV, the doctors wrote in the journal Frontiers in Cellular and Infection Microbiology.
Despite the serious risks of BV, the treatment is limited to antibiotics, creams or gels.
"We have very few treatment options available for BV, none of which is fully curative or restorative," said study author Dr. Ir. Ethel Weld.
This treatment prompted doctors to wonder if VMT could be effective.
& # 39; There is significant epidemiological evidence that vaginal microbiota transmission is already taking place, for example, between women who have sex with women & # 39 ;, said Dr. Weld.
The researchers tested their theory on 20 healthy women between 23 and 35 years old.
WHAT IS BACTERIAL VAGINOSIS?
Bacterial vaginosis (BV) is a common cause of unusual vaginal discharge.
It affects around one in three women at some point in their lives.
Although not an STD, it does increase a woman's risk of contracting a sexually transmitted disease.
BV is caused by a change in the delicate bacterial balance in a woman's vagina.
The most common symptom is a fish smelling discharge, especially after sex.
There may also be a change in the color or texture of the discharge, such as turning gray or watery.
But half of the women with BV experience no symptoms.
If a woman suspects she has BV, she should go to her doctor or clinic for sexual health to confirm that it is not an STD.
After diagnosis – via a cotton swab – BV is usually treated via prescribed antibiotic tablets, or gels or creams.
BV often returns within three months.
Those who receive it more than twice in six months must be treated for up to six months.
BV can be prevented by only using water to wash the genital area and by choosing showers above baths.
Scented soap, vaginal deodorants, showers, strong detergents and even smoking increase a woman's risk of the condition.
BV is more common in people who are sexually active, recently changed partners or & # 39; the coil & # 39; to have.
If & # 39; caught & # 39; during pregnancy, BV can lead to premature birth or miscarriage.
Concerned pregnant women must contact their doctor or midwife.
Source: NHS choices
The women completed a medical questionnaire and had their blood, urine and vaginal fluid examined.
The doctors believe that inexpensive tests reliably exclude women with sexually transmitted infections (STDs) or other safety issues.
Once deemed suitable, & # 39; the women collected their vaginal fluid & # 39; yourself & # 39; via a flexible plastic disk, similar to a menstrual cup, the BBC reported.
"It is quick and easy, and such a collected sample would be enough material to make one dose for transfer," Dr. said. Ensign.
A recipient would also self-administer the transplant & # 39 ;, placing the donor bacteria in a tampon-like device.
In the future, more expensive tests could screen the most promising donors, who would be assessed according to their Lactobacillus level & # 39 ;.
It is unclear what the & # 39; ideal & # 39; donor. However, the pilot study showed that the women whose vagina was dominated by the Lactobacillus species L. crispatus, had more lactic acid, which is protective.
They also had a lower pH and greater & # 39; HIV barrier function & # 39 ;, the study found. Bacteria, including those after BV, can thrive due to an alkaline pH.
& # 39; Once a safe donor has been identified using this protocol, it could donate on multiple well-screened occasions, & # 39; said Dr. Ensign.
& # 39; The idea of an & # 39; super donor & # 39; without identified previous or current infections and with favorable microbiota dominated by Lactobacillus, there is one to be investigated. & # 39;
The study also suggested that these super donors might be hard to find.
& # 39; Based on our exclusion criteria, seven out of 20 (35 percent) of these participants can be eligible VMT donors & # 39 ;, said Dr. Ensign.
& # 39; But the actual success rate for participating as a VMT donor in a clinical trial is likely to be much lower. & # 39;
The women were recruited from previous studies by the same researchers.
They were mostly white or East Asian. In the US, these ethnic groups probably have the least BV, the doctors claim. They hope to recruit a more diverse group of women in their upcoming studies.
However, persuading women to participate can be challenging, asking participants to go without sex for 30 days or more.
"Out of an abundance of caution, we suggest that donors abstain from vaginal intercourse for the duration of longitudinal sampling," said Dr. Ensign.
However, the researchers added that some donors from their pilot studies have shown interest in the upcoming trial.
& # 39; If we can get financing, we can start right away & # 39 ;, said Dr. Ensign.
& # 39; We plan to give transplants to 40 recipients to begin with. Some would receive the real work and others a placebo. & # 39;
All participants would also be treated with antibiotics, she added.
WHAT IS A FAECIAL MICROBIOTA TRANSPLANT? THE BIZARRE PROCEDURE REALIZING BACTERIA IN THE STOMACH
Faecal microbiotransplantation (FMT) is the transfer of faeces from a healthy donor to the gastrointestinal tract of a patient.
WHAT CAN IT TREAT?
It is usually used to treat relapsing C. difficile infection – spread through bacterial spores in faeces. It is 90 percent effective.
It can also be used to treat gastrointestinal disorders such as colitis, irritable bowel syndrome and constipation – but success rates are much lower.
Recent studies have investigated the benefits of treating conditions associated with a poor balance between & # 39; good & # 39; and & # 39; bad & # 39; bacteria in the gut such as autism.
Faecal microbiota transplant (FMT) is the transfer of faeces from a healthy donor to the gastrointestinal tract of a patient
FMT can supplement the bacterial balance because it acts as a probiotic, with faecal samples that often contain up to 1000 different types of bacteria.
HOW IS IT PERFORMED?
The transplant is ready through tubes – inserted into the nostril, throat and stomach – or directly into the colon.
However, the faecal sample can also be transplanted by enemas or pills containing freeze-dried material.
IS IT SAFE?
There have been reports of patients exhibiting unexpected weight gain after treatment, vomiting, and even abdominal pain.
However, the long-term safety and effectiveness of FMT is relatively unknown and researchers have called for more studies to determine the risks.
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