The survey was conducted in Tottori, Nagano, Hyogo, and Osaka, Japan.

December 11, 2017
Luke's Ashiya Cliniculcerative colitis

The application period has ended. Thank you for your cooperation.
You can download the result report below.
Author： Masahiko Shirotani, Luke’s Ashiya Clinic

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(1) Introduction

The Intestinal Flora Transplant Clinical Research Foundation is a non-profit organization that contributes to human health through research, development, and clinical application of intestinal flora transplantation.
Led by clinicians, we work to establish a new treatment called “intestinal flora transplantation (fecal microorganism transplantation)” and contribute to people’s health through the clinical application and research and development of intestinal flora transplantation.
Intestinal flora transplantation has almost no side effects, and our research group adopts a method that is light on both donors and patients.

The transplantation team belonging to our research group has performed more than 600 intestinal flora transplants to date, having developed a unique method of intestinal flora transplantation through more than 35 years of basic bacterial research. Although this is in the form of cooperation for clinical application and self-funded treatment, we have the largest number of transplant cases in Japan

Our research group has decided to conduct “a survey to compare the viability of bacterial solutions purified with saline solution and those purified with original transplant function water”. We ask only those who agree to bear part of the cost of the survey to participate in this project.

We collaborate with several medical institutions, including gastroenterologists, to ensure that patients can undergo transplantation with peace of mind.

Below is a comparison of the characteristics of our transplantation solution and the transplantation method used at our affiliated medical institutions and the general method (the method used in clinical trials at university hospitals and other hospitals).

2) Clinical Application Participation Eligibility

The following are those who can participate in the clinical application

1, No bleeding, ulcerative colitis 2, Any age, any gender (minors must have parental consent) 3, Those who agree that this is a clinical application and that they will be responsible for costs

In addition, patients who meet the following criteria are not eligible to participate:
1, bleeding
2, have serious complications such as stenosis or abscess requiring dilation and perianal abscess
3, have an active infection
4, have other serious complications such as diabetes, hypertension, hyperlipidemia
5, may be pregnant
6, Others who are deemed ineligible by the physician in charge.

In order for you to participate in the program, your physician may need to confirm your medical condition or other circumstances.

(3) Purpose and significance of this clinical application

Our independently developed transplants are characterized by the bacterial solution carefully selected and blended from the donor bank, the speed of implantation, and the high implantation rate after transplantation.
It shares with the common method in that impurities such as dietary fiber are removed from the stool as much as possible, and the stool is then converted to the state of bacterial solution.

The purpose of this study is to verify whether there is any difference in the speed and rate of transplantation of the same person using the same transplant solution used in the general method used at each university and the transplantation method used in our study group, regardless of the transplantation method.

The results of this study will provide an opportunity to greatly expand the potential of intestinal flora transplantation by demonstrating that transplantation can result in a high probability of gut bacteria viability, and to add intestinal flora transplantation as a useful treatment method in ulcerative colitis.

(4) Methods of clinical application

You can inquire about this research using the inquiry form on the Intestinal Flora Transplantation Clinical Research Foundation’s website. Please apply after agreeing that this is a clinical application and that a fee will be charged. You will be responsible for your own transportation costs to and from the institutions. Please refer to the following link to find the medical institutions that will be conducting the study.

Number of applicants

5 each at each practicing medical institution
(will close when capacity is reached)

Clinical Application Schedule

	Schedule
１	Stool sample kit and medical questionnaire are sent to the subject. The subject is asked to collect stool samples at home and return them to the research institute with a self-addressed envelope.
２	The first transplantation…The bacteria solution made with saline solution was transplanted to each subject by the following method.
３	After transplantation, the first stool sample is sent to the laboratory using a stool analysis kit.
４	One week later, the second transplant…Bacterial solution made with transplant function water was transplanted to each subject using the following method.
５	After transplantation, the first stool sample is sent to the affiliated clinic using a stool sample kit.
６	Schedule the third and subsequent transplants with the performing institution.

Transplantation

In order to verify that the implantation rate is independent of the transplantation technique, the following methods will be used

▼ Using colon fiber, bacterial solution made with saline and transplant function water, both implanted

• Cooperating clinic: Yorozu Clinic (Tottori)
• Director, Noriaki Man, Executive Director, Intestinal Flora Transplantation Clinical Research Foundation

▼ Implanted with saline using colon fiber and a rubber intestinal catheter using a bacterial solution made from the implanted functional water

• Cooperating clinic: Life Clinic Tateshina (Nagano, Japan)
• Director Masayuki Maue Holm (President, Intestinal Flora Transplantation Clinical Research Foundation)
• Cooperating clinic: Kawai Internal Medicine Clinic (Osaka, Japan)
• Director Yuichi Kawai (Full member of the Intestinal Flora Transplantation Clinical Research Association)

▼Bacterial solution made from both saline and transplant function water implanted with a rubber intestinal catheter.

• Cooperating clinic: Luke’s Ashiya Clinic (Hyogo, Japan)
• Director Masahiko Jotani (Executive Director, Intestinal Flora Transplantation Clinical Research Foundation)

Donor Selection and Pre-testing

The study group uses stools from donors who have been pre-registered with the donor bank.
Preliminary testing is conducted as follows

《Biochemistry I》
T-Bil, TP, AST (GOT), ALT (GPT), ALP, LDH, γ-GTP, T-Cho, TG, CK, Cre, UA, Glucose
(13 items)

《Immunology》
CRP quantitative, HBs antigen qualitative, HCV antibody, RPR qualitative, TP antibody qualitative, HIV antibody

《Hematology》
General hematology, leukocyte classification

《Others》
Urine General Qualification

(5) Treatment (response) after completion of participation in clinical application research

The purpose of this clinical application is to verify the speed and rate of bacteria engraftment in the general method of intestinal flora transplantation and in our transplantation method. However, our study group usually performs more than three transplants using our method with our bacterial solution. Therefore, in addition to verifying the speed and rate of implantation, we ask our subjects to understand that they must be satisfied that they will continue to be transplanted according to their condition before they can participate in the study.
For the fifth or more transplants, including the general method, please consult with the medical institution after the completion of the fourth transplant. For the cost, please refer to 7) below.

(6) Anticipated benefits and disadvantages

Projected Profit

It is expected that the combination of this study’s treatment in addition to the usual treatment of ulcerative colitis will be more effective, but there is a possibility of both benefit/disadvantage.
Your participation in this study will provide information to establish more effective treatments for future patients with ulcerative colitis and will contribute to society for the establishment of treatments.

Anticipated disadvantages

Side effects in clinical application participants (recipients)

Side effects reported with common fecal microbiota transplantation methods to date include fever, diarrhea, constipation, nausea, and increased blood pressure.
Other side effects have been reported with common fecal transplants in addition to those listed here. Please ask your physician for the most up-to-date information on side effects at any time. Also, please inform your physician or other health care provider of any changes in your condition during the course of the study.

Complications associated with testing in clinical application participants (recipients)

In this study, colonoscopy may be used at the time of implantation.
There is a possibility of complications associated with it, commonly bowel perforation and mucosal injury.
Sedatives (midazolam, propofol, etc.) may cause respiratory depression and hypotension.
Antibiotics are used prior to transplantation in the general procedure, which may have associated side effects.
The amount of blood drawn is almost the same as that used for physical examinations, etc., and there is no possibility of serious complications.

(7) Cost sharing

We ask only those who agree to bear some of the costs associated with clinical applications to participate in this program. (All prices are tax inclusive)

	usual	For Participants in Clinical Applications
	Intestinal flora transplant 3 times course	Intestinal flora transplant 4 times course
Price	1,049,760 yen	531,360 yen
Contents	-Gut flora balance test (2 times before and after transplant) -Donor test fee -Transplant bacteria solution fee (3 times) -Transplant bacteria solution adjustment fee (3 times) -Transplant procedure fee (3 times) -First medical examination and medical interview fee (2 times) -Medical aid water (for drinking)	Intestinal flora balance test (4 times before and after each transplant) ・Donor test fee ・Transplantation bacteria solution fee (4 times) General method 1 time + our method 3 times ・Transplantation bacteria solution adjustment fee (4 times) General method 1 time + our method 3 times ・Transplantation procedure fee (4 times) General method 1 time + our method 3 times ・First medical examination fee ・Interview fee (3 times) ・Medical aid water (for drinking)

Additional Treatment Costs

One additional transplant procedure (5th and 6th)	270,000 yen/times
Additional transplant procedures (7th)	216,000 yen/times
Additional transplantation procedures (after the 8th transplantation)	108,000 yen/times

Cancellation Policy

If you contact us by 12:00 PM 10 days prior to and including the first transplant date
→ we will return 100% of your deposit.

If you contact us after 12:00 PM 10 days including the first transplant day and before 12:00 PM 5 days before
→ we will return 50% of your deposit.

If you contact us after 12:00 PM 5 days including the first transplant day and before 9:00 AM the day before
→ we will return 25% of your deposit.

If we do not hear from you by 9 AM on the day of the first transplant
→ we will return 20% of your deposit.

The bank transfer fee for refunds will be borne by the applicant.

(8) Compensation for health damage

In the unlikely event that your participation in this clinical application results in any health problems, we will provide appropriate treatment.

If you experience any abnormalities during the research period, please inform your doctor, nurse, or other healthcare professional, no matter what.

In the event of a health hazard, appropriate action will be initiated immediately. In addition, compensation will be provided for health hazards, if necessary.

In this study, a single 25 ml blood sample will be drawn for research purposes. Since this blood sample will be drawn in exactly the same manner as a routine blood sample, we believe that this is unlikely to cause any major health hazards.

In the unlikely event that any symptoms of concern appear, please do not hesitate to contact us for any information. We will take appropriate measures according to your symptoms. In the event that tests or treatment become necessary, we will apply medical insurance (e.g., National Health Insurance) and ask you to pay for your own expenses as you would for regular medical treatment.

(9) Provision of information and access to materials related to this research

During the course of your participation in this clinical application, we will immediately notify you of any new information we receive that may affect your willingness to continue your participation in the study. If we obtain important information about this research, we will again confirm your willingness to continue your participation in the study.

If you would like to see more detailed information about our research plans and methods, please contact your physician or other relevant personnel.

We will disclose this information to the extent that the personal information of other subjects is protected and the originality of this research is maintained.

10) If you wish to discontinue participation in the research

Even after you have given your consent to participate, we may terminate the study or exclude you from participation in the study in the following cases

(1) When it is found that the patient does not meet the criteria for participation in the clinical application
(2) When the entire clinical application is discontinued
(3) In other cases when the physician in charge determines that continuation of the study is not desirable.

Even after discontinuation of clinical application, the patient’s health status may be followed up if deemed necessary by the physician in charge.

Even if you decide to stop participating in a clinical application, the data obtained up to that point will be used to protect your personal information, as it is valuable information about this clinical application.

However, if you withdraw your consent for clinical application, we will not use your data.

(11) Access by third parties to research records, etc.

In order to ensure that this research is being conducted properly while protecting the human rights of patients, the people involved in the research, government agencies, and other related parties may look at your medical records and other information. However, these parties are obliged to maintain confidentiality, so your name and other information pertaining to your privacy will be protected.

(12) Handling of personal information

Your data obtained from this study may be published in medical journals, but your privacy will be protected because your name and other personal information will not be revealed.

For information collected from the research data and medical records you provide, all information that can identify you (name, date of birth, address, etc.) will be excluded from these, and a registry number for this study will be assigned instead so that no one will know to whom the stool sample or information belongs.

However, we will create and keep a correspondence table that can link you to your registration number so that you can be identified in case of need. (This is called “linkable anonymization.”)

Thus, great care will be taken to protect your personal information.

(13) Methods of storage and disposal of samples and information

We will retain your materials and data from this study for at least 10 years from the final publication of the results of this study.

We will give due consideration to the protection of personal information when storing and disposing of data, etc.

In addition, the blood and other samples provided by you will be stored and disposed of with due care to protect your personal information.

(14) Handling of research funds and research results

Funding for Research

This research will be conducted at the expense of the patients who participate in the study and of the study group and the affiliated clinics belonging to the study group.

Attribution of Research Results

This research may result in future patents or other intellectual property rights. Please be advised that the results of this study are the property of the Institute and the members in charge of the study who belong to the Institute.

15) Requests while participating in this study

Please notify us if your oral medications, including ulcerative colitis medications, change during the study period.

If an antibiotic is taken internally or a new intestinal regimen is added or removed, the patient may be removed from the study from that point on.

(16) Person in charge of research and contact information (consultation service)

person in charge of research

• Yorozu Clinic ( Tottori)
• Director, Noriaki Man, Executive Director of the Intestinal Flora Transplantation Clinical Research Association, Inc.

• Life Clinic Tateshina ( Nagano, Japan)
• Director Masayuki Maue Holm (President, Intestinal Flora Transplantation Clinical Research Foundation)

• Luke’s Ashiya Clinic ( Hyogo Prefecture)
• Director Masahiko Jotani (Executive Director, Intestinal Flora Transplantation Clinical Research Foundation)

• Kawaii Internal Medicine Clinic ( Osaka, Japan)
• Director Yuichi Kawai (Full member of the Intestinal Flora Transplantation Clinical Research Association)

Person in charge of consultation

• Symbiosis LLC (Laboratory of Intestinal Bacteria) ( Osaka, Japan)
• Representative: Makoto Shimizu (Councilor, Intestinal Flora Transplantation Clinical Research Association)

• Intestinal Flora Transplant Clinical Research Foundation
• 19F Hilton Plaza West Office Tower, 2-2-2 Umeda, Kita-ku, Osaka 530-0001, Japan
• Tel：06-6948-5088 Fax：06-6777-2204
• Mail：info@fmt-japan.org

(17) How to apply

Please fill out the following inquiry form to apply.
Please enter ” Recruitment of Participants for the Comparative Study of Live Arrival Rates” in the subject line.

Inquiry Form