Japanbiome is a donor bank for fecal microbiota transplantation.
Our donors are volunteers who have passed strict testing standards and donate their stools with the hope that their healthy intestinal bacteria can be used to help people with illnesses.

What is a fecal microbiota transplantation?

More than 100 trillion unique intestinal bacteria live in our bellies and help us live healthy lives. Their roles include immunity, regulation of the autonomic nervous system, food metabolism, tissue regeneration, and communication with organs throughout the body.
The ecosystem of such intestinal bacteria is called "gut microbiota" or "gut flora".
Gut microbiota gradually change their ratio of existence and the strength (balance) of their functions every day in accordance with our physical and mental conditions, and minimize damage to our bodies.
However, due to westernization of food, overuse of antibiotics, excessive cleanliness, and stressful lifestyles, many modern people have more or less disrupted the intestinal flora. Advances in genetic analysis technology have revealed that disruption of the gut flora is involved in a variety of diseases.

The speed of generational change in gut microbiota is as fast as 20 minutes. Even gut microbiota that are still able to work vigorously are passed out of the body in the form of feces (poop). Fecal microbiota transplantation is attracting attention as an effective method to regulate disorganized gut microbiota by injecting the gut microbiota contained in the stool of a healthy donor into the intestines of patients suffering from illness or disease.

(1) Secure and share safe donor stools to make fecal microbiota transplantation more accessible.

In fecal microbiota transplantation in Japan, psychological considerations often dictate that donors within the second degree of kinship be found.
No scientific evidence has been presented for the use of a donor within the second degree of kinship who’s genetics and lifestyle are similar to the patient. In fact, there have been a series of reports that third-party donors with no similarities at all are preferred.
Furthermore, when a healthy donor cannot be found within the second degree of kinship, or when it becomes necessary to select an appropriate donor from outside according to the patient’s intestinal condition or clinical symptoms, finding a safe third-party donor that eliminates risks such as infectious diseases is a challenge.
In addition, it is not realistic from the aspects of economy, technology, and efficiency for individual medical institutions to search for donors in accordance with patients’ requests, confirm their safety, process their stool on site, and then perform fecal microflora transplantation.
By establishing an organized donor bank and sharing donors among multiple medical institutions, it is possible to provide a more economical, efficient, and stable supply of safe donor stools. Japanbiome aims to lower the hurdles to fecal microbiota transplantation for both clinicians and patients.

(2) Verify what donor characteristics should be selected for each patient

Even though research in the field of gut microbiota and fecal microbiota transplantation is well advanced overseas, the composition of gut microbiota differs from one ethnic group to another. For this reason, it is considered impossible to bring the results of overseas research directly to Japan.
In addition, donors with various backgrounds and gut microbiota are needed to treat various diseases.
This is because not only the lack of diversity of gut microbiota but also the distortion of the composition ratio by biological classification class (phylum, steel, order, family, genus, species, etc.) leads to disease, and unless the donor has the gut microbiota to improve that composition ratio, no amount of diversity is likely to lead to dramatic improvement.
Other donor characteristics (age, gender, constitution, lifestyle, etc.) must also be taken into account, in addition to the composition ratio of the gut microbiota.
This “difficulty in donor selection” may be the reason why fecal microbiota transplantation is not widely used for diseases other than CDI (Clostridium Difficile Infection) even outside Japan.
Japanbiome aims to facilitate the selection of the ideal donor for each patient and condition, with characteristics beyond “healthy”, by analyzing the patient’s condition individually and using the findings from statistics, in addition to donor attributes and blood and stool tests.

OpenBiome, the largest stool bank in the U.S., provides safe donor stools to medical institutions in Japan for use in patients with CDI. According to its website, it has provided more than 43,000 stools so far. In Japan, phase I clinical trials began in 2013 at eight institutions, including university hospitals, but have yet to yield remarkable results.

Click here for overseas comparison data

 

In Japan, legislation regarding fecal microbiota transplantation is at a stage where it is almost untouched.
According to the official position of the Ministry of Health, Labour, and Welfare, fecal microbiota transplantation is not currently covered by the Clinical Research Act that went into effect on April 1, 2018.
However, in Europe and the United States, government guidelines on fecal microbiota transplantation have already been published, and it is anticipated that legislation will be developed in Japan in the future.
Japanbiome is operating with reference to overseas guidelines, with a view to making fecal microbiota transplantation subject to the Clinical Research Act in the near future.

［Reference]

FMT Protocol

*FMT National Guidelines Steering Committee (National Institutes of Health, American Gastroenterological Association)

European consensus conference on faecal microbiota transplantation in clinical practice | Gut

*Clinical application guidelines for FMT agreed upon by a conference of 28 experts from more than 10 European countries.

Japanbiome operates under the guidance of the Ethics Committee of the Association for Clinical Research of Fecal Microbiota Transplantation Japan. The Ethics Committee examines whether the operation of Japanbiome is ethically sound with regard to the following issues;

In addition, regular meetings are held to exchange opinions and improve safety and quality.
*Ethics Committee approval date: June 20, 2019

Age, gender, height, weight, history of antibiotic use, natural childbirth/breastfeeding, medical history, use of medications and supplements, travel history, eating and sleeping habits, etc.

＜Examination by a doctor＞

- Blood pressure, pulse, auscultation, urinalysis

＜Blood test＞

- General blood tests:
White blood cell count (WBC), red blood cell count (RBC), hemoglobin (Hb), hematocrit (HT), MCV, MCH, MCHC, platelet count

- Biochemical and immunological tests:
Total protein (TP), AST (GOT), ALT (GPT), LD (LDH), alkaline phosphatase (ALP), ChE, total bilirubin (T-Bil), triglycerides (TG), total cholesterol (T-Cho), urea nitrogen (UN), creatinine, uric acid (UA), Na (sodium), Cl (chlor), K (potassium), Ca (calcium), P (inorganic phosphorus), glucose, serum iron (Fe), amylase (AMY), CK (CPK), specific IgE, IgE (non-specific IgE), reactive protein (CRP ), HbA1c (NGSP), eGFR, LDL-C/HDL-C ratio, ASO, rheumatoid factor (RF) determination, thyroid stimulating hormone (TSH) IFCC, cortisol, aldosterone, 250H vitamin D (osteoporosis), free triiodothyronine (FT3)CLEIA, free thyroxine (FT4)CLEIA

- Infectious disease tests:
HBs antigen (HQ), HBc antibody, syphilis qualitative RPR (LA), syphilis qualitative TP antibody (LA), HTLV-I (ATLV) antibody, HCV antibody (3rd generation), HIV antigen and antibody, EB virus anti-EA IgG, cytomegalovirus IgM, Covid-19 antibody

- Immune function tests:
CD4 x CD8, HLADR x CD3, CD16 x CD56, Cyto-3-C

- Tumor marker tests:
Alpha-fetoprotein quantification, SCC, CA125, fetal cancer antigen (CEA)

The above inspections are outsourced to the following inspection center:
SRL Corporation

＜Balance test＞

- 16S rRNA gene analysis of intestinal microflora

＜Stool test＞

- Bacterial resistance testing:
MRSA (methicillin-resistant Staphylococcus aureus), VRE (vancomycin-resistant enterococci), CRE (carbapenem-resistant Enterobacteriaceae), ESBL (extended-substrate specific beta-lactamase-producing bacteria)

* Food poisoning tests:
Staphylococcus aureus, Bacillus cereus, Bacillus welsh, Bacillus botulinus, Shigella dysenteriae, pathogenic E. coli (EPEC, ETEC, EHEC, EIEC, EAEC), Salmonella, Ersenia, Pleziomonas, Cholera, Vibrio parahaemolyticus, Vibrio naeguineae, Eromonas, Campylobacter spp.

- Immunological tests:
Clostridium difficile antigen, rotavirus antigen, Helicobacter in stool (Pylori antigen), Mycobacterium tuberculosis (PCR), pathogenic E. coli (O antigen serotyping), norovirus antigen (EIA), adenovirus antigen, myciscopy, fungal culture identification, general bacterial specimens, anaerobic culture identification, aerobic culture identification

The above tests are outsourced to genetic analysis companies and testing centers as follows.
Outsourcing to G-Cube Corporation: 16S rRNA
Outsourcing to BML Corporation: stool test items, resistant bacteria, food poisoning bacteria

Management structure

Japanbiome is operated by the Association for Clinical Research of Fecal Microbiota Transplantation Japan under contract to Clinical Research of Fecal Microbiota Transplantation Co., Ltd. The members and management system of Japanbiome will be disclosed and updated as needed on the website of the association.

Academic and publication information, etc.

Papers on fecal microbiota transplantation and papers on gut microbiota and various diseases will be added and updated as needed on the website of Symbiosis, Inc., which is affiliated with the Association for Clinical Research of Fecal Microbiota Transplantation Japan.

Click here for information on papers and research on intestinal bacteria (Symbiosis, Inc.)

Donor information

From the viewpoint of protecting donors’ personal information, in principle, we do not disclose personal information that can identify donors or detailed test results. However, when deemed necessary by the staff of our donor bank, we may share test results with the attending physician in charge in a form that does not identify the donor. In addition, patients undergoing transplantation are given a form containing a simplified summary of the donor’s test results and comments from the donor.

＜Donor examination doctor＞

Medical Corporation Jinzenkai Tanaka Clinic, Director Zen Tanaka

＜Staff＞

Makoto Shimizu, Senior Researcher, Symbiosis, Inc.
Chihiro Yamamoto, Researcher, Symbiosis, Inc.
Mikiko Tanaka, Intestinal Flora Transplantation Clinical Research Co.
Kyoko Mizutani, Intestinal Flora Transplantation Clinical Research Co.
Kyoko Okimoto, Intestinal Flora Transplantation Clinical Research Co.