Gut flora transplantation initiatives for patients with renal disease

Introduction

Active treatment to inhibit the progression of renal function for conservative chronic renal failure is currently mainly treatment for hypertension, hyperkalemia, renal anemia, hypocalcemia, and hyperphosphatemia in the current insurance system.
This time, by changing the diversity and balance of gut flora with FMT, we expect to suppress nephritis by immunity, excrete uremic substances, adjust acid-base equilibrium, adjust electrolyte balance, improve renal anemia, suppress renal function decline, and thereby avoid or delay the introduction of dialysis therapy due to end-stage renal failure as much as possible. Or we hope to delay the introduction of dialysis therapy due to end-stage renal failure as much as possible.

Target group

Renal function is serum creatinine 2~8mg/dl
(eGFR＜30, strictly speaking, eGFR measurement from cystatin C is preferable)
Male and female patients are acceptable.
Age: 20~60 years old
Primary disease: chronic glomerulonephritis (diabetic nephropathy if desired)

Method

Prior to FMT, a gut flora balance test is performed, the donor is determined accordingly, and a bacterial solution is prepared.
Patients are asked to fill out a quality of life questionnaire.
FMT is performed once a week (6 times), and after the 7th FMT, after consultation with the attending physician, FMT is continued once every 2 weeks for 3 times.
(for a total of 3 months)
Renal function is evaluated according to the above.

Cost

Transplantation fee: 6 times course 1,562,000 yen, additional 110,000 yen/time after the 7th transplant
Flora balance examination fee: 55,000 yen
Other medical examinations and tests not included in the transplantation fee

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If you are willing to cooperate with our 2-year check inspection

Two gut flora balance tests after transplantation will be provided free of charge.
One more box of hydrogen NanoGAS® water will be provided free of charge in addition to the one box included in the transplant cost.

*The cost of the transplant procedure will be billed to you by the Association for Clinical Research of Fecal Microbiota Transplantation Japan.
Please be sure to check our cancellation policy before applying.

*Consultation fees by a medical specialist (transplant consultation, nutritional guidance, etc.) will be charged separately.
*Gut flora transplantation (fecal microbiota transplantation) is a method undergoing clinical trials at university hospitals and other facilities nationwide, and transplantation at our study group is positioned as free medical care.

Visit this page for more information on the clinic’s transplantation process and costs.

Partner Medical Institutions

These are medical institutions where intestinal flora transplants are available.
All medical institutions use a bacterial solution manufactured by the exclusive research institute of the Intestinal Flora Transplantation Clinical Research Association following a standardized procedure.
In addition to the transplantation fee, any consultation with specialists (transplantation consultation, nutritional guidance, etc.) will be charged separately.

• Kanto region (including Tokyo, Kanagawa, Saitama, Gunma, Tochigi and Chiba prefectures)
• Chubu region(including Aichi, Nagano, Shizuoka, Niigata, Toyama, Ishikawa and Fukui prefectures)
• Kansai region (south-western half of Japan, including Osaka)
• Chugoku region
• Kyushu/Okinawa Region

Kanto region (including Tokyo, Kanagawa, Saitama, Gunma, Tochigi and Chiba prefectures)

Tokyo metropolitan area

Chubu region(including Aichi, Nagano, Shizuoka, Niigata, Toyama, Ishikawa and Fukui prefectures)

Nagano prefecture (Chuubu area)

Fukui prefecture (Hokuriku area)

Aichi prefecture (Chuubu area)

Kansai region (south-western half of Japan, including Osaka)

Osaka metropolitan area

Hyogo prefecture (Kinki area) (Hyougo)

Chugoku region

Tottori prefecture (Chuugoku area)

Kyushu/Okinawa Region

Fukuoka prefecture (Kyushu)

Kumamoto prefecture (Kyushu)

Facilities where transplant consultation is available

These are consultation facilities where you can ask questions about transplants, determine whether transplants are right for you, and discuss other issues from the perspective of your field of expertise.
Please note that we may not be able to respond to inquiries outside of our field of expertise.

Points to note

Information and Access to Materials Related to this Research
During the course of your participation in this initiative, if we learn of any new information that may affect your willingness to continue your participation, we will notify you immediately. If we receive important information regarding this initiative, we will re-evaluate your willingness to continue your participation.
If you would like more detailed information about this initiative, please contact your physician or other health care provider.
We will only disclose such information to the extent that the personal information of other subjects is protected and the originality of the study is maintained.

Regarding the viewing of records of this initiative and other information by third parties
In order to confirm that this initiative is being carried out properly while protecting the human rights of patients, related parties, government agencies, and others may view your medical records and other information. However, these parties are obliged to maintain confidentiality, so the patient’s name and other privacy-related information will be protected.

Handling of Personal Information
Your data obtained through this initiative may be published in medical journals, but your privacy will be protected because we will not reveal any personal information such as your name.
Regarding the information collected from the data and medical records you provide, all personally identifiable information (name, date of birth, address, etc.) will be excluded from these, and instead a registration number will be assigned exclusively to this study group, so that it is impossible to know who the stool sample and information belong to.
However, a correspondence table that can link the individual to the registration number will be created and retained so that the individual can be identified when necessary. (This is called “linkable anonymization.”)
In this way, due attention will be paid to the protection of personal information.

Storage and Disposal of Samples and Information
Materials and data obtained in this effort will be stored for at least 10 years from the final publication of the results of this research.
Careful consideration will be given to the protection of personal information when storing and disposing of data and other materials.

Requests during the transplant period
Please notify us if your oral medication changes during the study period.
Please inform your doctor if you have taken antibiotics or if a new intestinal regimen has been added or removed.

Examinations

Before FMT, 3 months after, and 6 months after
Gut flora balance test
Blood test
Quality of life questionnaire (attached)
< Inspection items >
Urinalysis (general qualitative, urinary sedimentoscopy)
Blood test
General biochemical tests (TP, Alb, T-Cho, Na-Cl, K, Ca, BUN, UA, Cre, P, glucose, eGFR, cystatin C)
PERIPHERAL BLOOD TESTS (RED BLOOD CELL COUNT, WHITE BLOOD CELL COUNT, HEMOGLOBIN, HEMATOCRIT, MCV, MCH, MCHC, PLATELET COUNT)

Patients' daily efforts

Drink 200 cc of hydrogen NanoGAS® water per day (during the transplant period)
Answer the questions in the Bacterial Power Up Diary online.
(answered one day before the transplantation date answered once every two weeks after the transplantation is completed)

Timing of various inspections

Bacterial power up diary

To be completed daily by the patient for each transplant
(Bristol Scale must be filled out daily)
Filled out twice a week after completion of transplantation

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