Clinical trial: NCT03998488
Section: Alternatives
Subsections: What Other Options Are **There?**

Instead of being in this study, you have these options:
- You may choose not to participate in this study
- You may choose to take standard medical therapy alone (for example, topical 5-ASA medications or topical steroids, oral steroids, immune modulators, and anti-TNF medications) or even surgery depending on what is recommended by your primary gastroenterologist.
Clinical trial: NCT03998488
Section: Confidentiality
Subsections: What About **Confidentiality?**|Genetic Information Nondiscrimination Act **(Gina)**|Hipaa Authorization To Use/Disclose **Protected Health Information For** Research Purposes For Using Or Sharing Protected Health **Information:** If You Decide To Join This Study, Wcmc|Other Use And Sharing Of Protected Health **Information**: If You Give Permission, The Researchers Could|Research **Repository** What Is A Research **Repository?**|Access To Research **Records**|Certificate Of **Confidentiality**

Efforts will be made to protect your medical records and other personal information to the extent allowed by law. However, we cannot guarantee absolute confidentiality. Records of study participants are stored and kept according to legal requirements and may be part of your medical record. You will not be identified personally in any reports or publications resulting from this study. Organizations that may request to inspect and/or copy your research and medical records for quality assurance and data analysis include groups such as:
o Weill Cornell Medical College and New York-Presbyterian Hospital o The Institutional Review Board (IRB) o The Office of Human Research Protection (OHRP) o Department of Health and Human Services and National Institutes of Health o The Food and Drug Administration (FDA) and/or their representatives By signing this consent form, you authorize access to this confidential information. You also authorize the release of your medical recordsto Weill Cornell Medical College and New York-Presbyterian Hospital by any other hospitals or institutions where you might receive medical care of any kind while you are participating in this study. If information about your participation in this study is stored in a computer, we will take the following precautions to protect it from unauthorized disclosure, tampering, or damage by requiring a unique ID and password to log into the database: All tissue, blood, or stool samples will be labeled with a unique alphanumeric identifier that does not link the specimen to the subject or the subjects' demographics. The samples are physically hand delivered to Dr. Longman's lab at WCMC by the PI and/or the research team. Identifiable samples are not sent to Dr. Longman's lab. A password protected database file will be maintained that links the samples with the subject. Only the study investigators will have access to this file. It will be stored in a password protected computer in a locked office. In addition, only personnel who are associated with the study will have access to the study specific records in the database. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  
This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

To the extent permitted by law, under no circumstances will any information linking you to specific test results be disclosed to any individual or organization without your written consent. A Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, health plans, and most employers to discriminate against you based on your genetic information. Thislaw generally will protect you in the following ways:  
- Health insurance companies and group health plans may not request your genetic information that we get from this research.  
- Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.  
- Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.
Be aware that this new Federal law does not protect you against genetic discrimination by companiesthatsell life insurance, disability insurance, or long-term care insurance. Nor does this Federal law prohibit discrimination on the basis of an already manifest genetic disease or disorder.

researchers need your permission to use your protected health information. If you give permission, Weill Cornell Medical College (WCMC) and/or New York-Presbyterian Hospital (NYPH) researchers may use your information or share (disclose) information about you for their research that is considered to be protected health information. Voluntary **Choice:** The choice to give WCMC and/or NYPH researcher's permission to use or share your protected health information for their research is voluntary. It is completely up to you. No one can force you to give permission. However, you must give permission for WCMC and/or NYPH researchers to use or share your protected health information if you want to participate in the study. If you decline to sign this form, you cannot participate in this study, because the researchers will not be able to obtain and/or use the information they need in order to conduct their research. Refusing to give permission will not affect your ability to get usual treatment, or health care from WCMC and/or NYPH. Protected Health Information To Be Used or Shared: Government rules require that researchers get your permission (authorization) to use or share your protected health information. Your medical information may be disclosed to authorized public health or government officials for public health activities when required or authorized by law. If you give permission, the researchers could use or share with the entities identified above any protected health information related to this research study from your medical records and from any test results, which includes HIV testing, hepatitis testing, additional blood tests (RPR, CMV IgM antibody, ESR, CRP), stool studies (routine stool culture for enteric GI pathogens: E. coli, *Salmonella, Shigella, Yersinia, Campylobacter, Cryptosporidium, Giardia, Vibrio, H. pylori,* Plesiomonas Shigelloides, Cylospora, Entamoeba, Adenovirus, Astrovirus, *Norovirus, Rotavirus*, Sapovirus), Ova and parasites, *Clostridium difficile* toxin by PCR, urine pregnancy test, colonic biopsies during colonoscopy, genetic testing (genetic sequencing of bacteria) from research only stool and biopsy
IRB 10/13/2022 Page 13 of 19 specimens, and immune cells taken from blood research samples.

also use your protected health information to develop new procedures or commercial products. They could share your protected health information with the study sponsor the WCMC Institutional Review Board, inspectors who check the research, government agencies and research study staff. The information that may be shared with the sponsor and/or government agencies could include your medical record and your research record related to this study. They may not be considered covered entities under the Privacy Rule and your information would not be subject to protections under the Privacy Rule.

A research repository (database) is a collection of information from the health and medical records of many individuals and can sometimes include identifiable specimens (like your tissue). The repository (database) may share the information with researchers who study medical conditions and diseases. The repository (database) includes codes that identify each person whose information is collected. However, the repository does not share information with researchers unless the researchers promise to keep the information confidential.

During the course of this study, you will not have access to see or copy specific sections of your protected health information that contains research information as described in this authorization form, in accordance with Weill Cornell Medical College (WCMC) and/or New York-Presbyterian Hospital (NYPH) policies. This is done to prevent knowledge of study results affecting the reliability of the study. The part of your private information that you will not have access to is: which arm of the study you are randomized to or any other information that is "blinded" (that is, kept secret during the study to prevent bias). Your information will be available should an emergency arise that would require the treating physician to know this information in order to best treat you. Your right to access this information will be reinstated after the completion of your week 8 **visit**. If you wish to appeal this temporary suspension at any time, please write to the Privacy officer at the address provided on this form. By signing this form, you are agreeing to this temporary suspension of your rights to assess protected health information.

A Certificate of Confidentiality has been granted by the Department of Health and Human Services (DHHS). This Certificate will protect the investigators (research/study staff) from being forced to release any research data in which the subject is identified even under a court order or subpoena. This protection is not absolute. For instance, it does not override any state requirement to report child abuse to the appropriate authorities.
Clinical trial: NCT03998488
Section: Duration of Study Involvement
Subsections: Follow-Up|How Long Will I Be In The **Study?**

Phone Consults: 2, 4, 6 and10 weeks after the FMT
o You will receive follow-up phone calls for evaluation of adverse effects and ulcerative colitis activity for research purposes. You will continue to receive follow-up phone calls every 6 months for the next year for research purposes.  
Importantly, you will follow up with your gastroenterologist as clinically indicated, and they will also ask you questions regarding your symptoms from the time of stool transplant, as well as perform further studies, as they feel is indicated by normal standards, such as colonoscopy, endoscopy, etc.

We think you will be in this study for a year. The research intervention visits along with clinical visits will occur over a 12-week period; however, you will receive follow up phone calls every 6 monthsfor the following year so that we can evaluate how you respond to this therapy long-term.  
You can stop participating at any time. However, if you decide to stop participating in the study, we encourage you to talk to the researcher and your regular doctor first. There will be no consequences of sudden withdrawal from the study. If you choose to not participate in the study or to leave the study, your regular care will not be affected nor will your relations with WCMC, New York-Presbyterian Hospital, your physicians, or other personnel. In addition, you will not lose any of the benefitsto which you are entitled.
Clinical trial: NCT03998488
Section: Participant's Rights
Subsections: What Are My Rights As A **Participant?**

Taking part in thisstudy is voluntary. You may choose to not take part in the study or to leave the study at any time. If you choose to not participate in the study or to leave the study, your regular care will not be affected nor will your relations with the Weill Cornell Medical College, New York-Presbyterian Hospital, your physicians, or other personnel. In addition, you will not lose any of the benefitsto which you are entitled. A Data Safety and Monitoring Board, an independent group of experts, will be reviewing the data from this research throughout the study. We will tell you about new information that may affect your health, welfare, or participation in this study.
Clinical trial: NCT03998488
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks Of The **Study?**|What Do I Need To Know About Reproductive Health And/Or Sexual Activity If I Am In This **Study?**|Are There Any Benefits To Taking Part In The **Study?**|What Are The **Costs?**|Policy/Procedures For Research Related **Injury** The Policy And Procedure For Weill Cornell Medical College Are As **Follows:**|Compensation For **Participation**

For trials of drugs and procedures, there may be risks. These risks will be discussed with you by the research doctor. Risks and side effects related to the stool **transplant** we are studying include: Risks from donor stool, such as serious blood-stream infection (rare) or fevers, abdominal cramping, bloating, diarrhea, and bloody stool (less likely). Complications may include but are not limited to the following:
a. Transmission of infectious organisms (bacterial, viral, fungal) contained in the stool a. Multi-Drug Resistant Organisms (MDROs)
i. A potential risk of fecal microbiota transplantation (FMT) is the transmission of antibiotic-resistant bacteria. These are bacteria that are resistant to some antibiotics. These bacteria could be transmitted through FMT and could cause serious invasive infection or death.  
ii. The study drug, FMP250, that will be delivered by FMT is provided by OpenBiome, a universal stool bank where donors who provide stool for FMT undergo regular screening for certain antibiotic-resistant bacteria. Each FMT is only made available when these screens do not detect antibiotic-resistant bacteria in the donor before and after the stool donation. Donors also undergo regular clinical assessmentsfor any risk factors associated with carrying antibiotic-resistant bacteria, such as recent use of antibiotics, visiting certain healthcare facilities, or certain travel activities.  
b. Shiga Toxin-Producing E. Coli (STEC) and Enteropathogenic E. Coli (EPEC)
i. A potential risk of fecal microbiota transplantation (FMT) is the transmission of STEC and EPEC. STEC is a type of E. coli that can produce a toxin called Shiga toxin. Shiga toxin can be transmitted through FMT and can cause symptoms like abdominal pain, diarrhea (often bloody), vomiting, and mild fever. Most people develop symptoms within 3-4 days of acquiring the bacteria, and most get better within 5-7 days. EPEC is another type of E. coli that can be transmitted through FMT and is generally carried asymptomatically but can sometimes cause transient watery diarrhea, similar to traveler's diarrhea. Symptoms typically resolve in a matter of days.  
ii. The study drug, FMP250, that will be delivered by FMT is provided by OpenBiome, a universal stool bank where donors who provide stool for FMT undergo regular screening for these bacteria. Each FMT is only made available to delivery when these stool screenings do not detect EPEC or STEC in the donor before and/or after the stool donation.  
c. SARS-CoV-2 Infection i. A potential risk of fecal microbiota transplantation (FMT) is the transmission of SARS-CoV-2, a novel coronavirus that causes the disease COVID-19. Infection with SARS-CoV-2 may be transmitted through stool and may cause serious illness or death. It is possible for healthy, asymptomatic stool donors to potentially be infected with SARS-CoV-2.  
ii. The FMT you will receive is provided by OpenBiome, a universal stool bank where donors who provide stool for FMT undergo regular stool, blood, and nasal screenings for many different infectious agents, including SARS-CoV-2, the virus that causes the illness called COVID-19. However, not all infectious agents are screened for and some infectious agents are as yet undiscovered. Each FMT unit is only made available for use when these screens do not detect the infectious agents for which we test. Donors also undergo regular in-person clinical assessments for any risk factors, including risk factors associated with carrying SARS-CoV-2, such as visiting certain healthcare facilities, or other behaviors that may increase the risk of exposure. However, because COVID-19 is so widespread, donors may be exposed or infected without having an identified risk factor for exposure. They may also have no symptoms of infection. OpenBiome continually updates its screening
IRB 10/13/2022 Page 9 of 19 guidelines and procedures as additional data, tests, and information become available.  
iii. If the FMT that you receive was made from stool donated after December 1st, 2019, either the donor's stool was tested for the presence of SARS-CoV-2 using a viral RNA test, or the stool donor wastested for the presence of SARS-CoV-2 using a nasopharyngeal swab at least every 14 days. Both kinds of test looks for the specific genetic material that makes up the virus. If a donor tests positive for SARSCoV-2, OpenBiome destroys any FMT units made from that donor in the 4 weeks
(28 days) before their positive test result. The donor is also disqualified from providing stool donations for at least 8 weeks. To be re-instated in the stool donation program after 8 weeks, the donor must pass all screens.  
iv. Although we cannot be absolutely certain, it is unlikely that SARS-CoV-2 is present in stool donations that were provided to OpenBiome on or prior to December 1st, 2019. For this reason, testing on donors prior to December 1st has not been performed.  
v. Though these precautions are taken to minimize the risk of SARS-CoV-2 transmission via FMT, the scientific and clinical community continues to learn more about SARS-CoV-2 and COVID-19. There are limits to the detection levels of laboratory tests, including those for SARS-CoV-2. Even with current screening and testing strategies, there may be additional risks that are unknown at this time. Although the donor screening tests we perform are likely to prevent you from receiving FMT from a donor who is infected with SARS-CoV-2, we cannot be absolutely certain that the stool you receive has not been contaminated with the SARS-CoV-2 virus.  
d. Monkeypox Infection i. A potential risk of fecal microbiota transplantation (FMT) is the transmission of monkeypox. Infection can cause symptoms including rash, fever, fatigue, myalgia, and respiratory symptoms which may be severe especially in immunocompromised patients. Studies have documented the presence of monkeypox virus DNA in rectal swabs and/or stool from infected individuals, but it is unknown whether monkeypox can be transmitted through stool or from asymptomatic infected individuals.  
b. Missed polyps, cancer, or other lesion (infusing donor stool interferes with visualization of colonic mucosa)
c. Allergic reaction to antigens in donor stool d. Enhanced ulcerative colitis activity e. Theoretical increased risk of developing disease which may be related to donor gut bacteria (i.e.  
obesity, metabolic syndrome, autoimmune conditions, allergic/atopic disorders, neurologic disorders, and/or malignancy)
Risks from colonoscopy and sigmoidoscopy, such as perforation (serious but less likely), abdominal discomfort during or after the procedure (common but mild), and risks related to sedation (less likely). The incidence of risk associated with biopsies taken as standard of care does not increase with additional biopsies taken for research. These risks include bleeding, intestinal perforation, and / or infection. Bleeding associated with biopsy generally resolves spontaneously, however, in the unlikely event of persistent bleeding, clips and / or cautery can be applied to stop the bleeding. Risk from Medical **Record Review**: Subjects will be asked about their medical history, usage of birth control, concurrent medication. There is a risk associated with the loss of privacy or confidentiality due to the probing of information. For example, if your identity as a participant in this study or your
IRB 10/13/2022 Page 10 of 19 identifiable health information were disclosed to unauthorized persons, there is the possible risk of discrimination by employers or insurance providers. Risk from Blood Draws: Drawing blood from a vein may cause local pain, bruising, occasional lightheadedness, fainting, and very rarely, infection at the site of the blood draw. Rarely, blood clots may form and infections may occur. If you feel faint, you should lie down right away to avoid falling down. You should let your study doctor or staff know if you have any of these problems. Risk from **Placebo:** In this research study, you may receive a placebo (inactive substance). If you receive the placebo, your condition may not change or may worsen. Risk from Psyllium Husk: The main concern with psyllium husk is the risk of choking, specifically if the product is not consumed with sufficient liquid. Our research physicians also hypothesize bloating may occur. The following rare side effects may be of concern for older adults: abdominal discomfort, nausea, mild abdominal cramps, griping, and faintness. Risk from Anti-Diarrheal Agents: Healthy adults usually don't experience side effects from antidiarrheal medicines. But side effects may be a concern if you are older or have health problems. Side effects of diphenoxylate/atropine may include: drowsiness, dizziness, headache, tiredness, restlessness, blurred vision, dry mouth, nausea, vomiting, upset stomach, loss of appetite, skin rash, or itching. Unlikely but serious side effects of diphenoxylate/atropine including: stomach or abdominal pain or swelling, severe nausea or vomiting, mental/mood changes (e.g., confusion, depression), or numbness and tingling of arms or legs. Side effects of loperamide may include: dizziness, drowsiness, tiredness, constipation, stomach pain, skin rash, or itching. Unlikely but serious side effects may also include severe constipation/nausea/vomiting, stomach or abdominal pain, or uncomfortable fullness of the stomach or abdomen. Risks for Women of Child-Bearing **Potential:** Participation in this the study may involve unknown risks to a pregnant woman, unborn baby or nursing infant. You must not take part in this study if you are pregnant, plan to become pregnant during the research study period, or are breast-feeding a baby.

If you are sexually active, you should use at least one effective means of birth control while participating in this research study. According to the World Health Organization and the United States Center for Disease Control and Prevention, the most effective forms of birth control include complete abstinence, surgical sterilization (both male and female), intrauterine devices (IUDs),
and the contraceptive implant. The next most effective forms of birth control include injectables, oral contraceptive pills, the contraceptive ring, or the contraceptive patch. Acceptable, but least effective, methods of birth control include male condoms (with or without spermicide) and female condoms.  
If you become pregnant while participating in this research study, it is important that you tell the study doctor or other research team member immediately. You will be required to stop receiving procedures and blinded FMT interventions for this study; however, other clinical care options will be discussed with you at that time if necessary and you will continue to complete the AE phone calls, week 4 clinic visit, and week 12 clinic visit as originally planned. The only difference will be that your week 8 assessment will be changed from a standard of care flexible sigmoidoscopy procedure into a clinic visit. This means you will do all other assessments, such as standard of care labs, research collection of blood and stool, physical exam, vital signs, height and weight measurements, etc. Therefore, the week 8 will no longer include a procedure, FMT blinded treatment, and biopsy collection for research.  
If you are considered to be postmenopausal, you are not required to use contraception while participating in this research study. Postmenopausal women rarely become pregnant.  
There may also be side effects, other than listed above that we cannot predict. Other drugs may be given to make side effects that occur less serious and less uncomfortable. Many side effects go away shortly after the stool transplant isstopped, but in some casesside effects can be serious, long lasting or permanent For more information about risks and side effects, ask the researcher or contact Dr. Randy Longman at 212-746- 5077.

We cannot and do not guarantee that you will receive any benefits from this study. We hope the information learned from this study will benefit other patients with ulcerative colitis in the future.

The study will pay for any related procedures that are not considered standard care for patients with your disease. You will not have to pay for the study drug (fecal microbiota transplantation), psyllium dietary supplements, blood and stool sample collection for research purposes, or the loperamide and/or diphenoxylate/atropine provided for stool retention at the day 0 colonoscopy. These services will be provided for research purposes by Weill Cornell Medicine at no cost.  
The physical examinations, standard laboratory tests, and diagnostic procedures, such as the colonoscopy and flexible sigmoidoscopy, are considered part of the standard care for patients with your disease who have had a change in clinical symptoms. The costs associated with each test will be charged to you or your insurance provider in the same manner asif you were not part of thisresearch study. You or your insurance company will be charged for continuing medical care and/or hospitalization that are not a part of the study. The costs of all of the other medications and the administration of these medications that you receive during this study will be charged to you or your insurance provider. If unsuspected, incidental findings are noted during blood or stool testing or during colonoscopy and further medical tests and/or treatments are considered, such tests and/or treatments are no longer considered part of the study and therefore would be billed to you or your insurer. You should expect no compensation or reimbursement for these costs or any risks and anxieties associated with any such follow up care. Therefore, you or your insurance provider will need to assume responsibility for these costs. You will be billed for all costs or co-payments that are not paid by your insurance provider. Taking part in this study may lead to added costs for you or your insurance company. Please ask about any expected added costs or potential insurance problems. You may wish to consult with your insurance company in advance about whether insurance will pay for these costs.

We are obligated to inform you about WCMC's policy in the event injury occurs. If, as a result of your participation, you experience injury from known or unknown risks of the research procedures as described, immediate medical care and treatment, including hospitalization, if necessary, will be available at the usual charge for such treatment. No monetary compensation is available from WCMC or New York-Presbyterian Hospital. Further information can be obtained by calling the Institutional Review Board at (646) 962-8200.

You will not receive compensation for participating in this study. You should not expect anyone to pay you for pain, worry, lost income, or non-medical care coststhat occur from taking part in thisresearch study.
Clinical trial: NCT03998488
Section: Procedures
Subsections: What Is Involved In The **Study?**|Study **Procedures/Assessments**|1. Screening **Visit**|2. Day 0 Colonoscopy And Study Drug Administration|Mucosal Biopsies For Research|Blood And Stool Samples For Research Collection 1:|Pregnancy Testing|Stool Sample Testing

This is a randomized, double-blind, placebo-controlled study done to test the role of supplemental psyllium fiber in the enhancement of efficacy of the investigational Fecal Microbiota Transplantation (FMT) done with the study drug, FMP250. If you decide to participate in thisstudy, you will be "randomized" at a 1:1:1 ratio into one of the following 3 research intervention groups provided all the inclusion and exclusion criteria are met:
IRB 10/13/2022 Page 3 of 19 Group 1: Investigational FMT
o Subject will receive investigational FMP250 once at day 0 colonoscopy o Subject will receive placebo FMP250 once at week 8 flexible sigmoidoscopy o Observed for 12 weeks Group 2: Investigational FMT + psyllium fiber o Subject will receive investigational FMP250 once at day 0 colonoscopy o Fiber supplementation of 1 teaspoon 2x/day (morning and night) for 8 weeks o Subject will receive placebo FMP250 once at week 8 flexible sigmoidoscopy o Observed for 12 weeks Group 3: Placebo FMT with or without psyllium fiber o Subject will receive placebo FMP250 once at day 0 colonoscopy o Half of subjects will be randomized to receive fiber supplementation of 1 teaspoon 2x/day (morning and night) for 8 weeks o Subject will receive investigational FMP250 once at week 8 flexible sigmoidoscopy o Observed for 12 weeks Randomization means that you are put into a group by chance. It is like flipping a coin. Neither you, the research team, nor treating clinician will choose what group you will be in. You will have an equal chance of being placed in any group, 2 in 3 chances of receiving investigational FMT with a 1 in 3 chance of receiving placebo (which looks exactly like study drug but does not contain active ingredient). This is a blinded research study; therefore, neither you nor the clinician will know which research intervention will be given to you at the day 0 colonoscopy or week 8 flexible sigmoidoscopy. Blinding subjects and clinicians is done to ensure the results of the research are not influenced by anyone. It is important to note that even though you may be randomized to one of the research intervention groups receiving the study drug, the final eligibility criterion is determined by endoscopic evaluation during the day 0 colonoscopy. There is a chance that you may not receive the study drug at all if you do not meet this final endoscopic criterion. The randomized assignment will not be made known to you or the study physician until all week 8 evaluations have been completed for all study participants. Therefore, if you were blindly randomized to receive placebo at the day 0 colonoscopy, you will be given the investigational FMT (FMP250) during your week 8 flexible sigmoidoscopy and if you were blindly randomized to receive investigational FMT (FMP250) at the day 0 colonoscopy, you will be given the placebo FMT during your week 8 flexible sigmoidoscopy In the case of a medical emergency, the randomized intervention you received may be revealed by the study coordinator to the study doctor upon request.  
Please advise the researchers of any medications you are taking. In addition, if you are taking any overthe-counter drugs or herbal supplements, which you have obtained, from the drug store, grocery store, etc., you should advise the researchers.

You will have the following tests and procedures as a part of thisresearch study:  
| Screening        |           |       |       |        |             |              |       |        |        |
|------------------|-----------|-------|-------|--------|-------------|--------------|-------|--------|--------|
| Study Procedures | Screening | Phone | Phone | Clinic | Phone  Call | Clinic Visit | Phone | Clinic |        |
| Colonoscopy                  |           |       |       |        |             |              |       |        |        |
| Period           | Call      | Call  | Visit | Call   | Visit       |              |       |        |        |
| Study Timeline   | Day       | Day   | Wk    | Wk     | Wk          | Wk           | Wk    | Wk     |        |
| Day              | Off       |       |       |        |             |              |       |        |        |
| -28 to -3        | 0         | 1     | 2     | 4      | 6           | 8            | 10    | 12     | Studyd |  
IRB 10/13/2022 Page 4 of 19  
| Informed consent                                              | X                         |              |    |    |    |
|---------------------------------------------------------------|---------------------------|--------------|----|----|----|
| Demographics                                                  | X                         |              |    |    |    |
| Medical history                                               | X                         |              |    |    |    |
| Concurrent medication                                         | X                         | X            |    |    |    |
| Intervention Randomization                                    | X                         |              |    |    |    |
| Physical exam                                                 | X                         | X            | X  | X  |    |
| Vital signs + Height + Weight                                 | X                         | X            | X  | X  |    |
| B-HCG (serum pregnancy  test) (research purposes)             | X                         |              |    |    |    |
| Urine Pregnancy Test (standard of care and research purposes) | Xc                        | X            |    |    |    |
| CRP: C-Reactive Protein (standard of care)                    | X*                        | X            |    |    |    |
| ESR: Erythrocyte                                              | X*                        | X            |    |    |    |
| Sedimentation Rate (standard of care) CBCa (standard of care) | X*                        | X            |    |    |    |
| CMPb (standard of care)                                       | X*                        | X            |    |    |    |
| Blood: HIV screen (standard of care)                          | X*                        |              |    |    |    |
| Blood: Hepatitis A B C Profile (standard of care)             | X*                        |              |    |    |    |
| Blood: RPR (Treponema  pallidum) (research purposes)          | X                         |              |    |    |    |
| Blood: CMV IgM (standard of care)                             | X*                        |              |    |    |    |
| Blood: Quantiferon-TB (standard of care)                      | X*                        |              |    |    |    |
| Fecal Calprotectin (standard of care)                         | X*                        | X            |    |    |    |
| Stool: Ova &parasites (standard of care)                      | X*                        |              |    |    |    |
| Stool:                                                        | Clostridium               | Difficile    |    |    |    |
| Toxin PCR (standard of care)                                  | X*                        |              |    |    |    |
| Stool: Gastrointestinal  Pathogen PCR Panele (standard of     | X*                        |              |    |    |    |
| care) Screening Colonoscopy (standard of care)                | X                         |              |    |    |    |
| Blinded (Investigational or  Placebo) FMP250 Intervention     | X                         |              |    |    |    |
| Follow-up Flex  sigmoidoscopy (standard of care)              | X                         |              |    |    |    |
| Blinded Investigational  FMP250 at week 8 (research purposes) | Placebo                   |              |    |    |    |
| FMP250 group only                                             |                           |              |    |    |    |
| Blinded Placebo FMP250 at                                     | Investigational           |              |    |    |    |
| Week 8 (research purposes)                                    | FMP250 group only         |              |    |    |    |
| Mucosal Biopsy Collection (research purposes)                 | X                         | X            |    |    |    |
| Blood and Stool Collection (research purposes)                | X ------- X               | X            | X  | X  |    |
| Follow-Up Phone calls (research purposes)                     | X                         | X            | X  | X  | X  |
| WEILL CORNELL MEDICAL COLLEGE                                 | IRB Protocol #19-04020045 | Page 5 of 19 |    |    |    |  
IRB 10/13/2022  
| Diet Recall with Clinical  Nutritionist or study MD                | X                                                                                                            |    |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----|
| (research purposes) Psyllium Fiber Supplements (research purposes) | X                                                                                                            | X  |
| Adverse event evaluation                                           | X                                                                                                            | X  |
| *:                                                                 | These standard of care laboratory tests are required to be conducted during the screening period. However if |    |  
Psyllium Fiber Supplements
(research purposes) X X
Adverse event evaluation X X
*: These standard of care laboratory tests are required to be conducted during the screening period. However if you consent below on page 5, this study may instead use recent laboratory results you had conducted within 2 weeks of signing consent.  
a: Complete Blood Count (WBC count, RBC count, Hb, Hct, platelet count)
b: Comprehensive Metabolic Panel (glucose, calcium, sodium, potassium, CO2, chloride, BUN, Creatinine)
c: Urine pregnancy test (women of childbearing potential) as standard of care for colonoscopy  e: Gastrointestinal Pathogen GI Panel (Campbylobacter species, Plesiomonas Shigelloides, *Salmonella* Species, Vibrio Species, Vibrio cholerae, Yersinia *Enterocolitica*, Enteroaggregative E. *coli* (EAEC), Enterpathogenic E. coli (EPEC), Enterotoxigenic *E. coli* (LT/ST), Shigalike toxin producing *E.coli* I (STX/ST2), *Cryptosporidium*,
Cyclospora caretanensis, Entamoeba Cayetanensis, Giardia, *Adenovirus* F 40/41, Astrovirus, *Norovirus* GI/GII,
Rotavirus A, *Sapovirus*, GID PCR INTERP)

Once the informed consent document has been signed, the research study will be initiated by a screening visit. This isintended to ensure that you meet all criteria for this study.  
During this visit, the clinician will ask about your medication and medical history and will also conduct a physical exam. Additionally, you will meet with a registered dietician or your study physician during the screening period (days -28 to -3), either by an in-person or phone call consult, for research purposes to assess what you normally eat on a regular weekday by going through a 24-hour diet recall. Standard of care blood and stool testing will be conducted, if not done within 2 weeks of signing this consent form, in addition to a few other tests for research purposes to further determine eligibility. More details on these specific tests can be found in the Study **Procedures/Assessments**section.  
Please check "Yes" if you consent to having your recent blood and stool laboratory results to be used to determine your eligibility into this study. These laboratory tests must have been collected within 2 weeks of signing this consent form. If you check "No" you will be asked to do all standard of care blood and stool testing after signing this consent form.

You will undergo bowel **prep** and food fasting as of midnight of the procedure date, as you do for your usual standard of care colonoscopies with biopsies. 1-2 hours prior to the colonoscopy procedure, you will receive an **anti-diarrheal agent(s)** (e.g. loperamide and/or diphenoxylate/atropine) to help with the retention of the fecal transfer for research purposes. The colonoscopy will be performed in the NYP Endoscopy suite using standard of care practices, and you will be monitored post-procedure using standard practices. The study clinician will evaluate and score your disease activity to determine if you are eligible to receive the study drug. If you are eligible, you will blindly receive either the active or placebo FMP250 for research purposes based on your randomization. The fecal suspension will be delivered by 60cc syringes via the colonoscope to the deepest level of insertion (ideally the ileum). Therefore, up to 250cc of the fecal suspension will be administered in aliquots of 60cc. You will be asked to retain the fecal transfer for as long as possible, ideally greater than 4 hours. Your randomized intervention will not be made known to you or the medical provider conducting the procedure until after an evaluation by flexible sigmoidoscopy at week 8.

A mucosal biopsy is the removal of a small piece, approximately the size of the tip of a pen, of your tissue from your intestine during an endoscopy procedure. Intestinal tissue biopsies may be tested to understand the effect of FMP250 and/or psyllium fiber, to predict who may respond to this intervention in the future, and to learn more about UC. During your colonoscopy, biopsies will be taken for diagnostic purposes. Additionally, 2 biopsies of the rectal tissue and 2 biopsies of the sigmoid tissue will be taken prior to the fecal microbiota transfer for research purposes. You will also undergo a flexible sigmoidoscopy with biopsies for standard of care at week 8. The same 4 biopsies from the rectal and sigmoid tissue will additionally be taken during this procedure for research purposes.

Prior to the day of your colonoscopy or if applicable, the initiation of psyllium husk, you will be asked to provide a pre-FMT stool sample for research purposes. You will also be asked to provide a blood sample and it will be drawn via venipuncture (the puncture of a vein with a needle to withdraw blood) and approximately 2.5 teaspoons of blood will be collected.  
Collection 2:
You will be asked to provide a stool and blood sample on the day of your post-FMT week 4 clinic visit.  
Collection 3:
You will be asked to provide a stool and blood sample on the day of your post-FMT week 8 clinic visit.  
Collection 4:
You will be asked to provide a stool and blood sample on the day of your post-FMT week 12 clinic visit.  
Pharmacodynamic blood testing Blood samples will also be drawn and used to test for certain proteins that may identify how your body is responding to the study drug, these proteins are called protein biomarkers.

If you are a female who can have children, you will provide a blood sample at the screening visit for research purposes, and then a urine sample for the colonoscopy as per standard of care protocol and at the week 8 clinic visit for research purposes to see if you are pregnant. A positive pregnancy result will disqualify you from being in the study.

The standard of care stool samples taken at the screening visit will predominantly be tested to measure active gut inflammation and to ensure you do not have any intestinal viral or bacterial infections. Another stool sample will be collected at the week 8 clinic visit as standard of care to again test for active inflammation. All other stool samples collected throughout the course of the study are for research purposes. These will be immediately stored and eventually used to investigate the effect of FMT and/or psyllium fiber, to predict who may respond to this type of intervention in the future, and to learn more about UC.
Clinical trial: NCT03998488
Section: Purpose of Research
Subsections: Why Is The Study Being **Done?**

Ulcerative Colitis (UC) is a disease that causes diarrhea and lower abdominal pain. The current standard treatments for UC includes medicines that help to reduce the inflammation of your intestines or change your immune system, including steroids. Biologic therapies may also be used, but they work in different ways to also help reduce inflammation in your intestines. Although there are numerous medications available for the management of UC, patients commonly become steroid dependent and/or intolerant to medical management. Human fecal microbiota transplantation (FMT) is also known as a stool transplant and is an emerging treatment for UC, however, its clinical efficacy is variable. This is done by delivering the study drug, FMP250, by fecal transplantation (FMT) ideally at the ileum. This procedure is used to treat severe or chronic Clostridium difficile colitis and, in this case, it will be investigated in ulcerative colitis with the intention of introducing normal bacterial flora from a healthy donor to a diseased colon. The purpose of this study is to determine the efficacy of investigational FMT (FMP250) and to determine if the efficacy of FMT is increased when taken with supplemental psyllium fiber for patients with mild to moderate ulcerative colitis.
Clinical trial: NCT03998488
Section: Voluntary Participation
Subsections: Consent For Research **Study**

Project **Title:** A randomized, placebo-controlled clinical trial examining the efficacy of Fecal Microbiota Transplantation (FMT) and subsequent dietary fiber in patients with moderate ulcerative colitis Principal **Investigator:** Dr. Randy Longman, MD PhD
Clinical trial: NCT03998488
Section: Withdrawal from Study
Subsections: Withdrawal By Investigator, Physician, Or **Sponsor**|Canceling **Authorization**

The investigators, physicians or sponsors may stop the study or take you out of the study at any time should they judge that it is in your best interest to do so, if you experience a study-related injury, if you need additional or different medication, or if you do not comply with the study plan. They may remove you from the study for various other administrative and medical reasons. They can do this without your consent.

Canceling Permission: If you give the WCMC and/or NYPH researchers permission to use or share your protected health information, you have the right to cancel your permission whenever you want. However, canceling your permission will not apply to information that the researchers have already used or shared. If you wish to cancel your permission, you may do so at any time by writing to:
Privacy Officer 1300 York Avenue, Box 303 New York, NY 10065 If you have questions about this, call (646) 962-6930 or e-mail: privacy@med.cornell.edu End of **Permission:** Unless you cancel it, permission for WCMC and/or NYPH researchersto use or share your protected health information for their research will never end.