Efforts of our study group’s stool bank Japanbiome on new coronaviruses

The Intestinal Flora Transplant Clinical Research Foundation and Japanbiome (Intestinal Flora Transplant Donor Bank) are working to ensure that patients who wish to receive an intestinal flora transplant can do so with peace of mind.
The number of patients who wish to undergo intestinal flora transplantation has been increasing as academic reports recognizing the usefulness of intestinal flora transplantation for various intestinal diseases such as ulcerative colitis, allergies, and autism spectrum disorders, including the application for multi-drug-resistant Clostridioides difficile infection recommended by the FDA, a US government agency, have been published around the world one after another. The number of patients who wish to undergo intestinal flora transplantation is increasing.

Amid global efforts to prevent the spread of the new coronavirus, Japanbiome has temporarily suspended the donation of stools from all donors and has been manufacturing transplantation solution only from stools donated by December 31, 2019.
We are pleased to announce that we will resume the donation and use of donor stools for transplantation solution at the end of 2019. In order to do so, we have reviewed the criteria for donor selection and the management system for handling transplantation solution as follows.

Although there are currently no reports of novel coronavirus transmission through intestinal flora transplantation (FMT), it is necessary to take the time to carefully assess the risk of infection.
Openbiome, the largest fecal bank in the U.S., is prepared to provide transplants to patients who need them while taking measures to prevent the spread of novel coronaviruses.

Japanbiome has established its own criteria in accordance with the “Guidelines for the Screening of FMT Donors under the Spread of New Coronavirus” by the International Expert Group and with reference to Openbiome’s response, taking into account the differences in circumstances and lifestyle between Japan and the United States and European countries. We have redefined the criteria in accordance with the “Guidelines for screening of FMT donors under the spread of new coronavirus infection.

(Reference: COVID-19 – OpenBiome https://www.openbiome.org/covid19
Screening of faecal microbiota transplant donors during the COVID-19 outbreak: suggestions for urgent updates from an international expert panel – The Lancet Gastroenterology & Hepatology https://www.thelancet.com/journals/langas/article/PIIS2468-1253(20)30082-0/fulltext）

【Restrictions and new criteria for donors resuming stool donation】

Japanbiome conducted antibody testing for novel coronavirus on all donors from June to July 2020, and confirmed that both IgG and IgM were negative. However, the system for testing healthy people and people who are not in close contact with infected people is not yet in place, and considering the burden on donors from frequent blood collection, it is not realistic to conduct frequent testing.

Therefore, in addition to the existing criteria, we have further established the following criteria and have decided to resume stool donation requests only to donors who meet the criteria.

• Travel across prefectures must be reported to the bank in advance.
• Must be able to provide stool in the treatment room in the bank. Or be able to pack the stool in a specified manner and bring it directly to the bank.
• No one infected with the novel coronavirus in himself/herself or in close contacts.
• Be sure to inform the bank that you will not be providing flights for 14 days after recovery from the illness, and that you must destroy any flights provided up to 14 days before retroactive from that point.

*Sickness is defined as the following conditions:
Fever over 37.5°C, vomiting, diarrhea, and other symptoms of the common cold.

In addition, to ensure the safety of donors and employees, we will continue to take measures such as restricting some access to the bank and reducing the number of people coming to work.

Q,Can I have stools donated before 2019 used?
→If you wish to use stools donated prior to the spread of the new coronavirus or prior to the time of confirmation of infection by the kit, please inform your transplant physician. For the time being, we have past donor stools in stock. In such cases, please understand that your donor options will be limited as we will use the donor stools that are in stock.

Q, If a donor is infected, is there any possibility at all that the stool may contain the virus or that antigens or antibodies may be transferred through transplantation?
→There have been reports of viruses being detected in the stools of infected donors. However, there is currently insufficient data to discuss the safety of infection by intestinal flora transplantation (FMT).
Therefore, Japanbiome is committed to increasing safety as much as possible by strictly enforcing donor travel and physical condition reporting requirements, based on the “Guidelines for FMT Donor Screening under the Spread of New Coronavirus Infection” by the International Expert Group.

Japanbiome will continue to closely monitor the development of the novel coronavirus, placing the safety of patients, affiliated medical institutions, donors, and employees as our first priority, and will strive to provide intestinal flora transplantation to patients who need it.

If you have any questions about the matters described on this page, please contact our institute or affiliated medical institutions.

【Other reference URLs】
DonorFAQ ― OpenBiome https://www.openbiome.org/donorfaq
Evidence for Gastrointestinal Infection of SARS-CoV-2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7130181/
COVID-19: Gastrointestinal Manifestations and Potential Fecal–Oral Transmission https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7130192/
How to Protect Yourself & Others | CDC https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html
Screening of faecal microbiota transplant donors during the COVID-19 outbreak: suggestions for urgent updates from an international expert panel – The Lancet Gastroenterology & Hepatology https://www.thelancet.com/journals/langas/article/PIIS2468-1253(20)30082-0/fulltext
AABB’s Coronavirus Resources http://www.aabb.org/advocacy/regulatorygovernment/Pages/AABB-Coronavirus-Resources.aspx