- [Interview]Expands treatment option to Clostridium difficile infection patients
“Stool may be perceived as useless and dirty, but used in the right way it actually can save lives to those in dire need.”
Kim Seok-jin, director of Kim Seok-jin Probiotics Lab 김석진좋은균연구소 and Gold Biome 골드바이옴, expressed his confidence that stool transplant can improve and even save lives of patients, who suffer from chronic intestine disorders.
Kim, who started out his career in periodontology, said his fascination with germs and their effects on the human body had led him to establish “Gold Biome,” the first stool bank in Korea.
Although the transplant has settled in as a norm in Western countries, the terms stool bank and fecal microbiota transplantation (FMT) are still somewhat unfamiliar to domestic doctors and patients.
“We have not commercially started the business since the establishment of the Gold Biome last June. However, the concept of the bank began in 2013. Since then, we have been preparing software, hardware and recruiting human resources needed for the facility to reach its full potential,” Kim said. “I can say that we are ready and we plan to share and expand knowledge of the benefits of FMT with the medical community.”
Gold Biome’s latest efforts have led to a memorandum of understanding with Seoul St. Mary’s Hospital서울성모병원 to study stool transplant. “We plan to expand stool transplant from here on with the help of the medical community,” he said.
Kim noted that the medical industry is a continually developing sector and there will always be new treatment and technology. Gastrointestinal microbiome marks one of the most significant advances in medical science, and it can modulate a variety of human illnesses, he added.
“Also, it is not that the doctors do not know about FMT, but rather lack the infrastructure to obtain and preserve stool donations. That is why we came up with Gold Biome so the doctors could solely focus on FMT operations,” he said.
As a result, Gold Biome’s primary goal is to finish all preparation before doctors operate with the fecal microbiota.
“Our job is to take the lead in initial research such as getting donations, extracting the good germ, keeping them in a stable condition and shipping them on the day of the operation so that doctors can concentrate on the surgery,” Kim said.
Korea’s first stool bank founder said that his company is also developing a donor matching program, which is patent pending.
The program will allow the company to use computer software to match the patient with the best suitable stool held in at the company’s bank. The software is expected to minimize time in picking a viable sample for the patient and help them make a quick and perfect recovery.
Therefore it is important to have the stool containing healthy fecal microbiota.
“The donor applicants have to go through a vetting process in criteria such as intestinal abnormalities, age, body mass index and blood work. Such strict inspection is necessary so that their donated stool does not have other bacteria or illnesses that can harm the patient,” Kim said.
This strict process limits the donor pool to a small number, however. “That is why a suitable donor is significant. Unlike blood donors, stool can be donated continuously without harming the donor,” he added.
In contrast to foreign countries, however, Korea forbids financial incentives when donating blood, sperm or even stool making it hard to attract donors. “Although the company cannot provide financial benefits to donors, it can provide a free, thorough medical checkup,” Kim said.
The company has obtained samples since they opened in June, but they are hoping to get more suitable donors, Kim added.
FMT still faces challenges in South Korea
The Ministry of Health and Welfare recognized FMT as a new treatment for curing Clostridium difficile infection on June 8, 2016. The ministry’s guideline states that patients with recurrent Clostridium difficile infection or those who are not responding to conventional antibiotic treatment can get treatment with FMT. Clostridium difficile infection has symptoms such as watery diarrhea, fever, nausea and abdominal pain that can even lead to death in severe cases.
The ministry has no specific guidelines regarding stool banks, though.
“As a front-runner in the industry we think the process is slow since we do not have any businesses to benchmark,” Kim said. “Although our company carefully benchmarked Open Biome, a stool bank in the United States, for certain details operating the bank, regulations in Korea are different from those in the U.S.”
The company is closely working with the ministry on setting the proper regulation and guide, he said, adding that the government’s role in the settling up the appropriate guideline for FMT and stool banks is limited.
“I believe that the scientific and ethical part of the procedure needs to be decided by the related medical sector. I hope to make a committee with doctors from various hospitals to research and set guidelines in FMT procedure,” Kim said.
Kim also mentioned the possibility of FMT used to cure other illnesses than Clostridium difficile infection.
“Some research proves that FMT can help patients who have chronic diseases such as constipation and irritable bowel syndrome,” Kim said. “This has to go through the Institutional Review Board, which approves, monitors, and reviews biomedical and behavioral research involving humans before used as a treatment for patients.”
In the end, the company plans to cater to the needs of individual patients and come up with a method to simplify the procedure.
“Although FMT will always remain as a viable option for clostridium difficile infection treatment, we hope to develop a probiotic that will treat patients without going through the hassle of FMT,” Kim said. “Currently, there are a few pharmaceutical companies and related institutes developing these types of drugs, including our lab.”
Until then FMT and stool bank will play a vital role in helping patients.
“This is what makes donations so vital,” Kim said. “Stool may look dirty and foul but donating stool is as important as donating blood. I hope the society’s view on the stool will change from just the foul excrement of the human body to a medical treatment that can save lives.”