Women who suffer from bacterial vaginosis (BV), a smelly vaginal infection that puts them at risk of contracting sexually transmitted diseases, alters their self-esteem and can lead to problems in their relationships or infertility, may have a cure.
Scientists at the Hadassah-Hebrew University Medical Center and the Weizmann Institute of Science have developed the first vaginal secretion transplant, known as a vaginal microbiome transplant in science. Microbiome is the name of the composition of all microbes, such as bacteria, fungi, protozoa and viruses, that live within the human body.
The findings were reported this month in an exploratory study published in Nature Medicine. The team was led by Dr. Ahinoam Lev-Sagie of HU and Prof. Eran Einav of Weizmann.RELATED
Lev-Sagie, a specialist in vaginal and vulvar disorders, told The Jerusalem Post that during his many years of patient treatment, a high percentage of patients who would come with BV would return during the year suffering from the same ailment.
"I couldn't cure them with antibiotics," he said.
Then, five years ago, one of his laboratory associates, Dr. Debra Goldman-Wohl, noted the fecal microbe transplant, which is now considered a first-line treatment for serious hospital acquired infections, such as Clostridium Difficile, in hospitalized individuals. In other words, transplant stool.
"It sounds disgusting," Lev-Sagie said, but Goldman-Wohl began to think that perhaps a new approach to BV could be developed based on similar principles. The Hadassah-Weizmann research was the first exploratory study conducted with this procedure in humans.
The approach involves the transplantation of a vaginal microbiome collected from healthy donors to recipients who suffer from intractable BV, with the aim of replacing their disease-promoting microbiome with that of a normal mixture of bacteria that reverses the symptoms of the disease, he explained. a statement from the study.
After a preventive treatment with antibiotics, which partially eliminates the niche of the bacteria that cause the disease, five patients with intractable BV received vaginal microbiome transplants (TMV). They were tested and followed for two years. The results: Complete remission in four of the five patients and a partial remission in the fifth recipient.
In two cases, a single dose of MVT induced a complete and lasting remission. In two other cases, the repetition of the TMV of the same donor resulted in a complete or partial remission, respectively. A fifth patient needed a donor change to achieve a complete and lasting remission.
"We believe that testing larger doses of TMV in future trials, or generating information on donor selection, could allow optimizing donor-recipient matching and improve the chances of complete success of this treatment," Lev-Sagie explained. "The results were incredible."
He said that in two of the patients the change was immediate; After a week, they healed completely.
"He just didn't come back," she said.
In addition to the innovative transplant, the team identified a mixture of “central strain” diners, which they explained in an explainer, could boost this clinical impact and further develop into a “microbial cocktail” that would simplify this procedure and reduce costs , by providing a first treatment.
The team did not observe any adverse effects associated with TMV during the study, but said more exploration would have to be done to rule out any risk, such as the theoretical risk of transferring a pathogen or causing an unwanted pregnancy due to sperm transfer.
The next steps will be to carry out a randomized, controlled and multicenter trial that tests the approach and cocktail of microbes in larger groups of women suffering from severe BV in different countries. The allocation of the participating centers and the recruitment for this study will be completed in the coming months.
"Issues related to women's health have often been poorly studied and even neglected in clinical medicine," said Lev-Sagie. "Bacterial vaginosis, although not life-threatening, is a very common female disorder that seriously affects the lives of women."
He said the condition affects about 80 million women worldwide.
"I think it is surprising that we, as doctors, have the option of offering people something that can change their lives," he concluded.