【IMPORTANT】OCCURRENCE OF FMT DEATHS IN THE U.S. AND THE RESPONSE OF OUR STUDY GROUP

July 01, 2019
FDA ANNOUNCES A DEATH IN FMT IN THE U.S. (JUN 13, 2019) Important Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms ［Summary of deaths] Two immunocompromised patients developed infections after receiving FMT, one of whom died. E. coli, which produces extended-spectrum beta-lactamase (ESBL), a type of resistant bacteria, was detected in the stool of the donor used for the transplant. As many people know, Escherichia coli (E.coli) is a bacterium that is endemic in the intestines and is not dangerous at all. Moreover, ESBL-producing strains that have acquired resistance are not harmful to health on their own, as the retention rate in Europe and the U.S. is only about 3%, but in healthy Japanese subjects it is more than 15%. (Reference) “ISOLATION STATUS AND CHARACTERISTICS OF ESBL-PRODUCING BACTERIA IN HEALTHY PEOPLE IN JAPAN.” Fecal carriage of Escherichia coli producing extended-spectrum β-lactamase with substrate specificity in healthy subjects and risk factors. owever, if the individual becomes immunocompromised or the normal bacterial flora is disrupted due to high antibiotic use, etc, We are currently preparing to disclose the operational structure of the donor bank as well as the safety management system of the study group. The problems in this case can be summarized as follows. THE PATIENT WAS IMMUNOCOMPROMISED, YET THE DONOR WAS NOT TESTED FOR BACTERIAL RESISTANCE. ESBL-PRODUCING BACTERIA ARE MINOR IN EUROPE AND THE U.S., AND THERE ARE FEW HEALTHY CARRIERS OF ESBLS IN THE U.S. We are currently preparing to disclose the operational structure of the donor bank as well as the safety management system of the study group. In response to this case, we believe that further disclosure of information is urgently needed, and we plan to upload this information to our website in the near future. In addition, we convened an Ethics Committee meeting on Thursday, June 20, and obtained approval for the following items of safety management. 1，Selection of donors, test items, and frequency of tests 2，From donor to donor bank 3，Hygienic environment until the stool is made into bacterial solution 4、Transportation to medical institutions 5、Management at the transplant site (handling of the bacterial solution, understanding the patient’s condition, etc.) In addition to the planned disclosure of the above information, the Ethics Committee and ad hoc Board of Directors meetings are currently considering limiting the number of patients eligible for transplantation and adding additional donor test items. However, no matter how rigorous the testing is, there are risks involved. The Society requires that medical institutions in charge of transplantation report the presence or absence of adverse events in conjunction with the transplant evaluation. So far, we have received reports of mild abdominal pain, diarrhea, hot flashes of the hands and feet, and mood discomfort. We will disclose information on adverse events as well as case reports to everyone in the future. If you are considering a transplant, please discuss the risks associated with this research item with your doctor, We recommend that you refrain from having an intestinal flora transplant at home or at a private clinic using donor stool that has not been tested. Medical institutions participating in our study group can be found at the following page. Find a nearby affiliated medical facility FINALLY, WE WOULD LIKE TO EXPRESS OUR DEEPEST CONDOLENCES TO THE PATIENTS WHO LOST THEIR LIVES IN THE ACCIDENT AND SINCERELY PRAY FOR THEIR REPOSE. GENERAL FOUNDATION FOR INTESTINAL FLORA TRANSPLANTATION CLINICAL RESEARCH ASSOCIATION RESEARCH SPECIALTY CLINIC FMT CLINIC MASAYASU INOUE