FAQ for Fecal Microbiota Transplantation

We have compiled a list of frequently asked questions regarding Fecal Microbiota Transplantation (FMT).

This guide provides basic information on the underlying mechanism, research status both in Japan and overseas, and key points to note during your visit.

Please note that individual eligibility and specific clinical procedures are determined through a consultation with a physician.

Basics of Fecal Microbiota Transplantation (FMT)

Fecal Microbiota Transplantation (FMT) is a medical procedure that transfers healthy intestinal bacteria to a patient’s gut. It is typically performed as a private-pay (out-of-pocket) treatment.

The mechanism and administration methods vary by medical institution. NanoGAS®-FMT incorporates our proprietary process management.

→ Click here for details: What is Fecal Microbiota Transplantation?

FMT stands for “Fecal Microbiota Transplantation.” In Japanese, it is also referred to as “Chonai Saikinsou Ishoku” or “Chonai Flora Ishoku.”

It is a medical procedure that optimizes the composition of the intestinal microbiota by administering healthy donor intestinal bacteria through methods such as oral capsules or liquids.

Intestinal microbiota (intestinal flora) is a general term for the diverse community of bacteria present in the intestines.

The term “flora” was inspired by the image of diverse bacteria coexisting like a “wildflower garden.”

FMT aims to introduce healthy intestinal bacteria to the gut to balance the composition of the intestinal microbiota.

Changes to the intestinal microbiota vary between individuals and are not identical for everyone.

Research on the relationship between intestinal microbiota and health is ongoing both in Japan and overseas.

Overseas, FMT is utilized for Recurrent Clostridioides difficile infection (rCDI), with extensive research reports available.

In Japan, clinical studies are currently underway in areas such as Ulcerative colitis, Irritable Bowel Syndrome (IBS), and Autism Spectrum Disorder (ASD).

Click here for a list of supported conditions

In Japan, FMT is not covered by public health insurance and is mainly conducted as a private-pay treatment or within clinical studies.

Research is progressing at national research institutions and university hospitals; however, official approval as a pharmaceutical product has not yet been obtained.

In the United States, FMT has received FDA approval specifically for recurrent CDI.

In Australia and Europe, stool bank systems and clinical trials are advancing, though the degree of regulation varies by country.

In 2022, an FMT-related preparation was approved in Australia (uses vary by country).

Indications, Visits, and Costs

Fecal Microbiota Transplantation (FMT) is conducted as a private-pay treatment. The assessment of eligibility, frequency, and costs vary by medical institution.

Detailed eligibility is determined by a physician through a consultation.

→ Click here for details: Costs for Fecal Microbiota Transplantation

    Not everyone is eligible.

    A physician will determine eligibility after reviewing your medical history, medication status, and screening for infectious diseases.

    As a first step, a consultation at an Affiliated medical institution is required.

    Medical areas extensively researched overseas include the following:

    • Recurrent CDI
    • Ulcerative colitis
    • Irritable Bowel Syndrome (IBS)
    • ASD
    • Atopic Allergies

    Other areas exploring the relationship with intestinal microbiota.
    However, as clinical efficacy and eligibility vary by individual, a consultation is necessary for confirmation.

    The number of transplantations and intervals vary depending on the consultation results and the policy of the medical institution.

    A personalized schedule will be provided after your consultation.

    The physician will determine the feasibility of combining treatments after checking your current regimen (medications, supplements, etc.).

    Please provide these details during your consultation.

    The number of patients and statistical information vary depending on the clinical status of the medical institution.

    The latest information can be found on the official website (case data, research information, and columns on the intestinal environment).

    The perception of results and progress varies from person to person.

    Since the intestinal microbiota is also affected by lifestyle habits, continuous follow-up and monitoring are recommended.

    Costs vary depending on the number of sessions, test items, and the policy of the medical institution.

    Details will be provided on an individual basis by the medical institution.

    We also outline the cost components on the “Costs for Fecal Microbiota Transplantation” page of our website.

    At present, FMT in Japan is a private-pay treatment and is not covered by public health insurance.

    Yes, it is.

    At Affiliated medical institutions, you can book a “Consultation only” or “Advice only” session.

    For those living overseas, please contact us via the inquiry form on our website.

    Yes, Fecal Microbiota Transplantation (FMT) is a medical procedure performed in an outpatient setting.

    The specific flow and required time vary by medical institution.

    It is possible, but multiple visits for the initial consultation, tests, and transplantation may be necessary.

    The possibility of rescheduling depends on the medical institution.

    The risk is not zero.

    Temporary changes in physical condition, such as Bloating or changes in defecation patterns, may occur.

    If you notice any abnormalities, please consult your medical institution immediately.

Flow and Preparation Before Receiving Fecal Microbiota Transplantation

There are several stages before undergoing Fecal Microbiota Transplantation (FMT), such as the initial consultation, tests, and review of the results.

For NanoGAS®-FMT, we utilize a procedure that does not require antimicrobials as a pre-treatment, proceeding step-by-step while monitoring test results and physical condition.

→ Click here for details: Flow from initial consultation to transplantation

    The general flow for Fecal Microbiota Transplantation (FMT) involves the following steps:

    1. Reservation at an Affiliated medical institution
    2. Initial consultation, interview, and necessary tests
    3. Physician’s assessment of eligibility
    4. Explanation and signing of the consent form, and payment of the pre-transplantation support fee
    5. Scheduling the transplantation

    Implementation of Fecal Microbiota Transplantation (FMT)
    For details, please see the “Flow from initial consultation to transplantation” page.

    The period from the initial consultation booking to the first transplantation varies depending on the test requirements, donor stool preparation, and the availability of the medical institution.

    Typically, it may take about 2 to 4 weeks.

    For international patients, preparation and logistics after confirming the pre-transplantation support fee payment require more time. Therefore, please expect an average of about 6 months, and at least around 4 months, until the first transplantation.

    To proceed with the transplantation, the following steps are required after the initial consultation:

    • Confirmation of eligibility by a physician
    • Signing of multiple explanation and consent forms, such as the “Consent for Treatment” and “Important Matter Explanation Document”
    • Payment of the pre-transplantation support fee

    Finalizing the first transplantation date
    Specific details will be provided individually by the medical institution after the consultation.

    Patients may undergo stool, blood, and urine tests.

    The purpose is to evaluate the state of the intestinal microbiota and its relationship with overall health.

    Separately, donor stool undergoes rigorous testing, including infectious disease screening.

    ▶ About safety management of the donor bank: 

    https://fmt-japan.org/en/technical-features/japanbiome

    After you submit your stool sample,

    The results are usually explained during a consultation approximately 1 to 2 weeks later.

    Yes. The results will be explained by the attending physician.

    If you wish to have a copy of the results, please request it from the medical institution during your consultation.

The Day of Fecal Microbiota Transplantation

On the day of transplantation, the bacterial solution will be administered using the method explained in advance.

After completion, you will be monitored according to the physician’s instructions and receive guidance on post-treatment care.

    You may be advised of the following points:

    • Attire: Loose-fitting, comfortable clothing that is easy to change in and out of.
    • What to bring: Health insurance card, consent forms (if prior submission is required), and any required health tracking documents.

    Food and drink: Please follow the specific instructions provided by your medical institution regarding dietary restrictions (such as fasting for breakfast).
    Specific precautions will be provided individually by your medical institution.

    Pain perception varies among individuals.

    If you have concerns, we recommend discussing them with your physician in advance during the consultation.

    The time required varies depending on the method and preparation, but it typically takes approximately 30 to 60 minutes, including the consultation, preparation, and explanation.

    Please follow the guidance from the medical institution regarding the schedule and the flow of the day.

    Transplantation may be possible during menstruation, but the decision depends on your physical condition and the specific condition being treated.

    If you have concerns, please consult with your physician in advance and reschedule if necessary.

After Treatment and Follow-up

After the Fecal Microbiota Transplantation (FMT), you will continue to consult with your physician regarding changes in your condition and the state of the intestinal environment.

Since lifestyle and diet affect the intestinal environment, the physician may provide advice on daily living as needed.

    Specific aftercare guidance will be provided by the medical institution, but generally, the following points may be advised:

    • Refrain from strenuous exercise, alcohol, and overeating for a short period after transplantation.

    Please follow the physician’s instructions regarding the use of intestinal regulators, antimicrobials, etc.
    Any special precautions will be explained during the consultation on the day.
    Since instructions vary by institution, please prioritize the guidance provided by your doctor.

    The necessity and timing of re-testing depend on your symptoms and progress.

    An Intestinal Flora Balance Test may be conducted after about 1 to 2 months as a guide, subject to the attending physician’s judgment.

    The duration of changes in the intestinal environment varies by individual.

    Furthermore, because the intestinal environment is influenced by daily habits such as diet, sleep, and stress management, maintaining a healthy lifestyle is essential.

    Follow-up tests every few months may be recommended to monitor progress.

    The physician will evaluate the need for additional transplantations based on changes in symptoms and test results.

    Even if you request additional sessions, clinical standards for intervals and frequency apply. Please always consult with your medical institution rather than making a self-judgment.

    Temporary fluctuations in physical condition may occur after transplantation.

    This is sometimes referred to as “rebound” and can occur as the intestinal environment adjusts.

    If symptoms persist or if you have any concerns, please consult your medical institution.

Donors and Safety Management

In NanoGAS®-FMT (Fecal Microbiota Transplantation using NanoGAS® water), which is our proprietary technology, rigorous screening of donor health and infectious disease risk is conducted via the management system of our affiliated donor bank.

Bacterial solutions are manufactured and managed in dedicated facilities, with all quality and test information carefully recorded.

→ Click here for details: Management of donor health status

https://fmt-japan.org/technical-features/japanbiome

    A stool bank is an organization dedicated to providing donor stool to medical institutions for Fecal Microbiota Transplantation (FMT).

    By supplying multiple medical institutions, a stool bank ensures a stable and reliable supply.

    The donor bank “Japanbiome®” is operated by The Association for Clinical Research of Fecal Microbiota Transplantation Japan.

    Japanbiome® is a domestic private donor bank that supplies donor stool for Fecal Microbiota Transplantation (FMT).

    Registered donors must meet strict screening criteria, including blood tests, stool tests, and lifestyle interviews.

    Furthermore, the bank works in cooperation with medical institutions to select the most suitable donor according to the patient’s condition.

    Details here:

    https://fmt-japan.org/en/technical-features/japanbiome

    A bacterial solution is a liquid in which donor stool is suspended in a specialized solvent.

    In Fecal Microbiota Transplantation (FMT), this bacterial solution is administered according to the protocol explained by the medical institution.

    In NanoGAS®-FMT, NanoGAS® water is used as the solvent.

    NanoGAS® water is water in which nano-sized bubbles (nanobubbles) are uniformly dispersed. It is used as the solvent for the bacterial solution in NanoGAS®-FMT.

    Adverse Events refer to any unfavorable health problems that occur after a treatment.

    “Side effects” are those where a causal relationship with the treatment is confirmed, while “Adverse Events” are recorded broadly regardless of whether a causal relationship is established.

    For NanoGAS®-FMT, the medical institution and the donor bank collaborate closely to monitor and manage Adverse Events.

    Summary of FAQ for Fecal Microbiota Transplantation

    Fecal Microbiota Transplantation (FMT) is a medical procedure that is tailored to the individual based on consultation at a medical institution.

    If you have any questions or concerns, please first consult an Affiliated medical institution.

    The physician will evaluate your condition and provide detailed guidance regarding the procedure and schedule.

    → Click here for guidance on Affiliated medical institutions

    https://fmt.sym-biosis.co.jp/en/transplantation/partner

If you are concerned about your intestinal flora, start by consulting us.

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