In two cases, a single dose of VMT induced a long-lasting and complete remission.
By MAAYAN JAFFE-HOFFMANDr. Ahinoam Lev-Sagie(photo credit: Courtesy)Women who suffer from bacterial vaginosis (BV) – a smelly vaginal infection that puts them at risk for sexually transmitted diseases, alters their self-esteem and can lead to problems in relationships or infertility – may have a cure.Researchers from Hadassah-Hebrew University Medical Center and the Weizmann Institute of Science have developed the first vaginal discharge transplant, known as vaginal microbiome transplantation in science speak. Microbiome is the name for the composition of all of the microbes, such as bacteria, fungi, protozoa and viruses, that live on and inside the human body.The findings were reported this month in an exploratory study published in Nature Medicine. The team was led by HU’s Dr. Ahinoam Lev-Sagie and Weizmann’s Prof. Eran Einav.Lev-Sagie, a specialist in vulva and vaginal disorders, told The Jerusalem Post that during her many years treating patients, a high percentage of the patients who would come in with BV would come back within the year suffering from the same ailment.“I could not cure them with antibiotics,” she said, adding that the condition impacts around 80 million women worldwide.Then, five years ago, one of her lab associates, Dr. Debra Goldman-Wohl, took note of fecal microbiome transplantation, which is now considered a first-line treatment for severe hospital-acquired infection such as Clostridium Difficile in hospitalized individuals. In other words, transplanting feces.“It sounds disgusting, actually,” Lev-Sagie said, but Goldman-Wohl started thinking that maybe a new approach for BV could be developed based on similar principles. The Hadassah-Weizmann research was the first exploratory study ever done using this procedure in humans.The approach consists of transplantation of a vaginal microbiome collected from healthy donors into recipients suffering from intractable BV, with an aim to replace their disease-driving microbiome with that of a normal mixture of bacteria that will reverse disease symptoms, a release on the study explained.Following a preemptive antibiotic treatment, which partially clears the niche from the disease-causing bacteria, five patients with intractable BV received vaginal microbiome transplants (VMT). They were tested and followed up with 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 VMT induced a long-lasting and complete remission. In two other cases, repeat VMT from the same donor resulted in complete or partial remission, respectively. A fifth patient necessitated a change of donor in order to achieve a complete long-lasting remission.“We believe that testing larger VMT doses in future trials, or alternatively generating insights on donor selection, may enable [us] to optimize donor-recipient pairing and improve the chances of full success of this treatment,” Lev-Sagie explained. “The results were amazing.”She said that in two of the patients the change was immediate: After one week, they were completely cured.“It just did not come back,” she said.In addition to the ground-breaking transplantation, the team identified a “core strain” mixture of commensals which, they said in an explainer, may drive this clinical impact and may be further developed into a “microbial cocktail” enabling simplification of this procedure and reducing its costs, in providing a first treatment.The team did not observe any adverse effects associated with VMT during the study, but said more exploration would need to be done to rule out any risks, such as the theoretical risk of transferring a pathogen or causing unintended pregnancy due to transfer of sperm.The next steps will be to carry out a randomized, controlled multi-center trial testing the approach, and the core microbe cocktail in larger groups of women suffering from severe BV in different countries. Allocation of the participating centers and recruitment to this study will be finalized in the coming few months.“Topics related to women’s health have been often under-studied and even neglected in clinical medicine,” said Lev-Sagie. “Bacterial vaginosis, while not life-risking, is an exceedingly common female disorder that bears a severe toll on women’s lives.“I think it is amazing that we, as physicians, have the option to offer people something that can change their lives,” she concluded.
