Transplantation of intestinal bacteria (flora)
What is intestinal flora?
Intestinal flora is the ecosystem of bacteria living in the intestines. Research is beginning to show that the presence of intestinal bacteria is essential for people to live a healthy life.
If the diversity of the intestinal flora is lost due to lifestyle or stress, or if the balance of the intestinal flora is too far from the general balance, it can cause various diseases.
Learn more about intestinal flora.
What is a gut microbiota transplant?
It is not easy to restore the intestinal flora to its original state once it has collapsed. In order to restore the balance of intestinal bacteria that have collapsed, there are growing expectations for a treatment method that involves transplanting intestinal flora from healthy people. (Scientific name: Fecal microbiota transplantation, FMT)
Click here for more information about intestinal flora transplants.
Is there any progress on intestinal flora transplant research around the world?
China in the 4th century. In the West, research has been conducted since a 1958 report on pseudomembranous enteritis.
In 2014, the U.S. Food and Drug Administration (FDA) positioned intestinal flora transplants as the treatment of first choice when multiple drugs are resistant to Clostridium difficile infection, and the effectiveness of these transplants is being medically proven. They have also shown favorable results against ulcerative colitis, Crohn’s disease, and irritable bowel syndrome, and are being studied as a treatment for other diseases.
What is the current situation in Japan?
In Japan, a clinical trial (Phase I) focusing on ulcerative colitis and Crohn’s disease began in 2013 at university hospitals and other facilities in various regions.
Intestinal flora” began to attract a great deal of interest when the NHK special “Intestinal Flora Revealed! The Amazing Power of Bacteria” aired on NHK in February 2015. In the future, it is expected that intestinal flora transplants will be utilized more in the field of medicine in Japan.
How far along is the legislation?
In Japan, there is almost no legislation regarding intestinal flora transplants. According to the official position of the Ministry of Health, Labour and Welfare, transplantation of intestinal flora does not fall under the Clinical Research Law that came into effect on April 1, 2018.
However, in Europe and the U.S., the governments have already announced guidelines for intestinal flora transplants and it is expected that the law will be developed in Japan in the future. The Intestinal Flora Transplantation Clinical Study Group operates with reference to overseas guidelines, with a view to intestinal flora transplants becoming the subject of a clinical research law in the near future.
What diseases has it been proven effective for?
The target diseases for intestinal flora transplants are being verified around the world.
At present, published studies show that intestinal flora transplants have been performed for the following diseases.
- Recurrent Clostridium difficile infection
- Ulcerative colitis
- Crohn’s disease
- Irritable bowel syndrome
- Metabolic syndrome
- Autism spectrum disorder
In addition, diseases that have been linked to gut bacteria include:
- Atopic allergies
- Type 1 and type 2 diabetes
- Dyslipidemia, obesity and hypertension
- Mental disorders
- Diseases related to pregnancy, childbirth and menstruation
- Other autoimmune diseases and lifestyle-related diseases
However, some disease states may not be eligible for intestinal flora transplants by the Intestinal Flora Transplantation Clinical Study Group, so please consult with our affiliated medical institutions for more details.
For a list of publications, please visit the Symbiosis Institute website.
Transplantation of intestinal flora using proprietary nanobubble technology
Where can I get an intestinal flora transplant?
There are affiliated medical institutions throughout Japan. For more information, please see Medical Institutions Where Transplants are Available.
Can anyone receive a transplant?
Although we do not have strict restrictions based on disease or age, we will first ask you in a medical examination whether your condition has limitations with standard treatment.
Some diseases may not be eligible for transplantation, so please consult with our affiliated medical institutions for details.
How many examples have you had to date?
Since 2017, we have performed over 500 transplants for people with various diseases.
Please click here to view the patient’s voices, including follow-ups up to several months after the transplant.
Are there any side effects or safety concerns?
Intestinal flora transplants are expected to have few side effects.
However, there are rare comments about the condition of stools, such as constipation-prone patients having soft stools or diarrhea-prone patients having hard stools.
In addition, some intestinal diseases, such as ulcerative colitis, may cause bleeding depending on the timing of transplantation. Atopy and allergies may cause itching and other symptoms due to the rebound phenomenon of the initial transplant, but we aim to alleviate this by performing subsequent transplants without a period of time between them.
Click here for a list of adverse events.
What is rebounding?
Young people, especially those between 10 and 17 years of age, have a strong immune system, so their health often fluctuates due to this rebound until their body learns the new intestinal flora balance.
This is proof, rather than a side effect, that the transplanted intestinal bacteria have reached the intestinal tract properly. Our method performs multiple transplants in a short period of time to help prevent the body from overreacting.
Is the transplant painless?
Most common intestinal flora transplants involve the use of a colonoscope. While this method has the advantage of allowing pinpoint transplantation, it places a heavy burden on the patient in terms of prior dietary restrictions and pain. At medical institutions affiliated with the Intestinal Flora Transplantation Clinical Research Group, an intestinal injection method is mainly used, in which a soft rubber catheter is inserted through the anus. Please be assured that the procedure is painless and takes only 10 to 15 minutes.
What is the number of transplants and how often?
We offer a course of three or six sessions, but the number of sessions varies greatly depending on the type of disease, the number of years affected, and the progress of the disease. There are also individual differences depending on the patient’s constitution and lifestyle.
Some patients may have 20 or 30 courses, while others may have preventive courses on a regular basis such as once a month.
The patient’s wishes and a conference between the attending physician and the transplant team will determine the general course of treatment, after which the patient will be monitored while undergoing transplantation.
Can I use it in conjunction with treatments or medications I receive at other hospitals or supplements I buy on my own?
Intestinal flora transplants utilizing our proprietary nanobubble technology can be used in combination with most standard and folk therapies. In very rare cases, temporary interruption of medication may be recommended, so please consult your doctor during a preliminary consultation. For more information, please consult with our affiliated medical institutions.
How is it different from other intestinal flora transplants?
There are many differences between the method currently used at various university hospitals participating in clinical trials and the method utilizing our proprietary nanobubble technology. These differences include the transplantation method and donor selection, but the most important difference is the method of dissolving stool.
By using NanoGAS® water for stool processing, we aim to minimize rejection during transplantation.
Please also see the difference from the general method.
How long do the effects of the transplant last?
We believe that once the intestinal flora has become your own through transplantation, it will not return so easily unless you are under a great deal of stress or lead a reckless lifestyle.
However, the intestinal flora balance that appears in the stool test can change because it also reflects bacteria that were only temporarily staying in the intestinal tract, such as those found in food and supplements.
To maintain good physical condition and flora balance, it is important to have a normal diet and other lifestyle habits.
Is the transplant provided on a walk-in basis?
Most of our affiliated medical institutions offer outpatient services.
I live far away and it is difficult for me to make many visits to the hospital.
For those who do not have an affiliated medical institution nearby, it is possible to schedule transplants on consecutive days. Please contact the affiliated medical institution for details.
Is it possible to transplant a foreigner?
It depends on nationality, length of stay in Japan, disease status, etc. Please inquire in each individual case.
About the donor bank
Are donor stools safe?
Donors are thoroughly examined on a regular basis to ensure in advance that they are free from common lifestyle diseases, infectious diseases, and malignant tumors.
Learn more about our donor bank
Who operates the donor bank?
The affiliated donors are managed and administered by our partner, Symbiosis, Inc.
Currently, Japan does not have sufficient legislation regarding transplantation of intestinal bacteria (plexus).
The Volunteer Donor Bank is an organization that aims to provide medical institutions with safe donor stool for stool transplantation. By sharing stool donors among multiple medical institutions through the donor bank, it is possible to provide a more efficient and stable supply of safe donor stool.
Can a transplant transfer the donor's personality?
For intestinal flora transplants utilizing our unique nanobubble technology, we do not use antibiotics to weaken the intestinal bacteria.
We aim to transplant the bacteria while preserving the “individuality” of the patient.
However, patients with a disease are often somewhat depressed and they may “brighten up” or “become more active” as their symptoms improve following transplants. We have no experience with donors’ personalities being affected by transplants.
The process of transplanting intestinal bacteria (flora)
What is the transplant process?
First, you will visit our affiliated medical institution to learn more about your condition. We will conduct a preliminary intestinal microbiome test (it takes about one and a half months to receive the results) and perform several transplants. We can also perform transplants without waiting for the results of the analysis test, so please consult with us. (In that case, please understand that we will adjust the general balance based on the medical questionnaire.)
The average time from the first transplant to the completion of three transplants is approximately one month, and the average time from the first transplant to the completion of six transplants is within two months. Your doctor will follow up with you to determine the course of treatment.
Please also see the transplantation process.
Can I just discuss transplantation?
We believe that it is important for patients to be able to undergo transplantation with full understanding. We believe that the more patients understand and feel comfortable with the transplant, the better their post-transplant outcomes will be. We will be happy to explain anything to you as many times as you need before the transplantation, so please feel free to contact us.
Note: A separate consultation fee will be charged at the affiliated medical institution.
How are stool tests performed?
The Intestinal Flora Transplant Clinical Study Group requests that patients undergo a home stool test for intestinal flora balance before and after transplantation in order to collect research data. Depending on the patient’s condition, the testing method or process may be omitted or changed.
In some cases, individual testing may be performed at a medical institution. Please consult with your doctor.
Can't you disclose the test results?
The results of the intestinal microbiome test are returned by the medical institution.
However, there is no set reference value for the intestinal flora balance test as there is for general blood tests.
- The relationship between intestinal flora balance and disease is not clear.
- Individual definitions of healthy intestinal flora balance vary widely and the interpretation of your flora balance may change when the medical interview is taken into account.
- Even if the flora balance appears to be the same, the interpretation changes when the medical interview is taken into account.
Please understand that changes in intestinal flora balance alone may not be the only explanation of your condition.
How long does it take from transplant application to first transplant?
For the intestinal flora balance test that is performed in advance, it takes approximately one and a half months to receive the test results after the stool sample is collected at home and returned to us. In some cases, transplantation can be performed without waiting for the test results, so please consult your medical institution.
After your application for transplantation, we will send you an invoice from Intestinal Flora Transplantation Clinical Research Co. After confirming payment of the transplant fee, please make an appointment at the medical institution at least 8 business days in advance.
About the day of transplantation
Are there any restrictions or requirements the day before or the day of the procedure?
There are no specific restrictions on eating or drinking either the day before or the day of the procedure.
During transplantation, you may be asked to change into paper pants. There are typically no special items to bring or clothing requirements. However, this may not be the case for some affiliated medical institutions, so please contact the affiliated medical institution for details.
How long does the transplant take?
The transplant itself takes about 10 to 15 minutes, although the time required for preliminary interviews and other procedures varies depending on the medical institution. After that, we take time to reposition the patient and have the patient rest. Please be assured that the transplant is performed in a simple manner with little physical burden on the patient.
What if I am menstruating on the day of the transplant?
Transplants may be performed wearing paper pants that can be soiled, so please consult with the clinic in advance. Even if you are menstruating, it will not affect the transplant procedure or the effectiveness of the transplant.
Are there any precautions to take after the transplant?
Please be sure to release gas while sitting on a toilet after the transplant. The fluid that held the intestinal bacteria will be released, but rest assured that the intestinal bacteria were already established. Otherwise, you may continue as usual. In the unlikely event that you feel something unusual about your condition, please contact your doctor immediately.
When am I retested after a transplant?
Please follow the instructions of the attending physician at the affiliated medical institution.
During and after transplantation
Is there an expiration date on the discount for additional transplants?
No. If you have received a transplant in the past, you can receive an additional transplant any number of years thereafter.