Fecal Microbial Transplantation in Patients With Crohn's Disease
Phase: EARLY_PHASE1
Conditions: Crohn Disease
Sponsor: Stony Brook University

Stony Brook University Hospital 
Department of Pediatrics, Division of Gastroenterology 
Health Science Tower 
101 Nicolls Road 
Level 11 Room 080 
Stony Brook, New York 11794-8111 
P: 631-444-7269 F: 631-444-6045 
 
 
 
 
August 30, 2019 
 
Title: Fecal Microbial Transplantation in patients with Crohn’s disease 
ClinicalTrials.Gov NCT03267238 
 
Please find enclosed the following documents: 
 
1. IRB approved protocol 
 
 
07/24/2019 
2. Recipient permission-consent form 
 
07/03/2019 
3. Recipient assent form  
 
 
07/03/2019 
4. Donor permission consent form  
 
07/03/2019 
5. Donor assent form 
 
 
 
07/03/2019 
 
 
Sincerely, 
 
 
 
Ellen Li, MD, PhD. 
Professor of Medicine/ Division of Gastroenterology  
Stony Brook Medicine 

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
Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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-. B2:

Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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
Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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-)-
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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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--20 -220
==
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52-0
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>2<.-
-2-23##:#0
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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)


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-32
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20-22
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2287++87$ $"=3$&,-
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$ 581B2
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$ 581B2--2
2<0=0
12--02B2+>0-,-
2122-0#-
#-20-29#2-
2-081B2#20-
21.81B202-3-H
2#2B20;022
F20
---
+
B*8B2
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<-22;
B*8B*802(
/220= 
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
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:--
B2F2-
-2*'(51:+1(*8E#E#0,
2-22(0;
3"<0;2-2
00
7
52##-#-
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222-22
-2-22-2220B2
B2-22-0-#
-20-29
-223B2#
20-21.81B202-
3-H2#2B20;0
22

Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)


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,87+ "$#=!% % ->0
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30+70324,+#3)#$:
3), 220 = 30 #
/2S)#2--0-
2222-.
1::-+1,*
2222-2
2222+>,# 200 +5,# ; +E'*,#
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/2)#;<+/())T,2<
2E>2-)2--
22-E>2-2=!3
-B22-2--
2/())T#;B2+/'',2
/''#22N2-+N,32-
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:
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0+##,02-50:2# =!
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:#:0:0
<#0-2
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2-52#D#12,
=
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#B20-
@
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:0
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8:
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0
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#$ 8:)2.-2#
.###-2#-#:
0<-207&
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02:-
--:2

Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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0-2

Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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1-320-
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5",
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1-<$2905)#
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
Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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0$&H$$ =3!
$?08#?21#50#'---)82)20
822---18;1)$ H$ & %3 $ 
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/2$!H  +=,& %3"
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/6!H&=&3&$
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8/6$H=&"%3 
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-04*%H$&="&=3"
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##2#'5*/6120-7$=H$%3&
5--2/#/21#(-2'D#4#2-2---
;2-054/$!H&$=3$=!
$625?#(1#/0U#)2-
2----2-0
1*$&H=!=$3&
)#?#?0#)5-'--2-82
8-02---*-07-7
$ H=3%

Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)


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52-074$ H$"!3%=
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2-22---7)-$&H$&$%$
=R2#)224#506?#E#-;-+),
2-22---7))$ H$=$=
=$?#87#5)#'---E2303)
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$!H$"$%"&3$%%
=E54#F;/6#81#'--0-5--*F
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=('#6)#/215#-00#--E
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$H! "=
==7::45#70#7(4#2----
/6$$H%$==3%
=&..-...220-.2
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..2=""-
= )#V6/#D1/#-#-
0-V5'53/'=H &&3&$

Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)


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
=%545#?5#*F#1/2)
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&F7#);1)##50:-2-0
)$=H$$3!
&$..3..-232.-0.XXXXX$=-
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
Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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52--

Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)


!0! !!  4D)!&  !-, 3&1&!&!.
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!(!&( 2(!"%
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. &&"(2! 8A7*
Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)


C
 !!  4D)!&  !
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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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GF;
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
Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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8!%( !!$#! 
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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

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
Approved: July 24, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

                                                                                                                 Page 1 of 8 
 
 
RECIPIENT RESEARCH PERMISSION/CONSENT FORM (CROHN’S) 
 
Project Title:    
 Fecal microbial transplantation in patients with Crohn’s disease 
Principal Investigator: Ellen Li, MD, PhD 
Co-Investigator: 
 Anupama Chawla, MD  
 
Departments: Medicine/Gastroenterology and Pediatric Gastroenterology & Nutrition 
 
When we say “you” in this consent form, we mean you or your child; “we” means the doctors and 
other staff. If you are a parent or legal guardian of a child who may take part in this study, 
permission from you is required and the assent (agreement) of your child may be required. 
You are being asked to be a volunteer in a research study. You are encouraged to take your time 
in making your decision. You may want to discuss this study with your friends and family. 
PURPOSE 
The purpose of this study is: 
 To determine the safety and tolerability of fecal (stool) transplantation to treat Crohn’s 
Disease. 
 Crohn’s Disease (CD) is a chronic disease affecting the colon without a medical cure. The 
precise cause of having inflammatory bowel disease (IBD) such as Crohn’s disease, 
Ulcerative colitis, or indeterminate colitis is unclear. However, genetics and the 
environment are thought to play a role. Studies have found that patients with Crohn’s 
Disease have a decreased prevalence of protective bacteria and an increase in harmful 
bacteria in the colon. Inflammation in the colon in these patients is thought to be due to 
this imbalance between helpful and harmful bacteria. Currently, the treatment of IBD 
includes steroids, anti-inflammatory medications and biological therapy, each with its own 
side effects. Given the role of the gastrointestinal bacteria in driving inflammation in 
patients with IBD, treatments that manipulate these bacteria have been investigated, 
including the use of medications containing beneficial bacteria (probiotics), with some 
benefit. Fecal transplantation (FMT), the transfer of gastrointestinal bacteria (microbiota) 
from a healthy donor via infusion of a liquid stool suspension, is proving to be an effective 
alternative treatment for Crohn’s Disease. The treatment appeared to improve clinical 
symptoms and lower inflammatory markers. The goal of this method is to remove the 
harmful bacteria in the colon and replace them with normal bacteria. 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

                                                                                                                 Page 2 of 8 
 
Since you have Crohn’s Disease and your symptoms have not improved with the medications you 
are currently on, fecal transplantation is a treatment option for you. As mentioned before, several 
studies have found that this transplantation is helpful in improving the symptoms associated with 
IBD, such as abdominal pain and diarrhea. This study hopes to document fecal transplantation’s 
safety and tolerability and improve or even eliminate your symptoms by performing the 
transplantation and then following-up routinely with you for one year. We will perform stool and 
genetic studies on you to see if the bacteria in your colon really did change after the 
transplantation and if any of your genes influence the composition of your colon bacteria.  
 
We expect to enroll a minimum of 40 patients in this study at Stony Brook University Hospital. 
 
PROCEDURES  
If you decide to be in this study, your part will involve:  
 You will first have to choose somebody who will donate the stool which will be 
transplanted. The donor can be anyone who we will consent separately and who meets 
eligibility criteria to donate stool. He/she will be asked questions and screened by 
performing bloodwork and stool studies to make sure he/she is a healthy candidate for 
stool transplantation. We will not share the lab results of your donor specimen with you 
even if they fail the inclusion criteria.  
 After the donor is chosen and he/she meets criteria to donate stool, we will give you a date 
for the fecal transplantation which will be done during a colonoscopy.  
 If you are of child-bearing age, a pregnancy test will be given to you as a clinic standard of 
care before the colonoscopy procedure. If the test result is positive for pregnancy we will 
not perform the fecal transplantation colonoscopy.  
 During the week before fecal transplantation, we will ask you to record everything you have 
eaten on a diet record which we will provide to you. Stool for research will be collected 1-3 
days before your day of fecal transplantation.  
 On the day before your transplant, you will be given instructions for a bowel prep to clean 
out your colon completely so it can be visualized well when we perform the fecal 
transplantation and make the procedure more effective. For the last 7 hours before your 
scheduled fecal transplantation, you will have nothing to eat or drink. 
 On the day of the transplantation, you will arrive at Stony Brook University Hospital and go 
to the Endoscopy Suite, located on the 14th Floor. There you will change into a hospital 
gown and an intravenous line (IV) will be placed to provide you with fluids and sedation 
during the colonoscopy. Four teaspoons of blood will be taken for research, to perform 
genetic studies. 
 Your donor’s stool will be prepared and while you are properly sedated, the stool will be 
instilled into your colon. 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

                                                                                                                 Page 3 of 8 
 
 At the time of scope and transplant, if the scope reveals anything clinically suspect that 
might require a biopsy, or the physician decides that the colon is not healthy enough, then 
the transplant will not be done. 
 You will stay in the Endoscopy Suite, lying on your right side, for at least one hour. This is to 
maximize contact between the transplanted stool and your colon. If you are not cleared to 
depart after one hour, you will stay until the anesthesiologist (doctor who administered 
sedation during colonoscopy) does clear you to depart. You will be able to eat and drink 
right after you wake up and can resume normal activities as soon as the anesthesia wears 
off and you feel well. 
 You will receive a phone call the day after the procedure, and be asked various questions to 
determine your general well-being. 
 You will then receive weekly phone calls for 12 weeks at a convenient time for you, to ask 
you further general well-being questions. 
 You will keep another diet record during the first week post-transplant. 1 week after your 
fecal transplantation you will collect stool for research, similar to how you collected stool 
prior to your stool transplantation.  
 You will keep another diet record during the 12th week post-transplant. 12 weeks after your 
fecal transplantation you will collect stool for research, similar to how you collected stool 
prior to your stool transplantation.  
 After your 12-week stool collection and testing, you will receive monthly phone calls until 
one year after the transplant to determine your general well-being. 
 If you are diagnosed with bacteria in your blood within past 4 weeks (28 days) of intended 
FMT, you will be excluded from the study. 
When you are first recruited for the study, you will be assigned a coded number. Stool and 
blood collected from you and follow-up questionnaires will all have your coded number so your 
information will not be directly linked to your samples and medical or diet diary information. 
 
RISKS / DISCOMFORTS  
The following risks/discomforts may occur as a result of you being in this study:  
 Although donor stool is vigorously screened for infectious agents, there is a still a rare risk 
of an infection with harmful bacteria and multidrug resistant organisms (MDRO) being 
passed from the donor’s stool to you. MDRO are common bacteria that have developed 
resistance to multiple types of antibiotics. These bacteria are present on the bodies of some 
people and they can co-exist with normal bacteria and cause no symptoms (“commensal”) 
or lead to serious infection spreading to the blood and other organs (“invasive”). Invasive 
infection is more common in patients with compromised immunity. Infections caused by 
MDRO are correlated with increased illness, death and prolonged hospitalization. Measures 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

                                                                                                                 Page 4 of 8 
 
have been implemented for donor screening (exclude donors at higher risk of MDRO 
infection) and donor stool testing (exclude stool that tests positive for MDRO) 
 Uncommon risks associated with fecal transplantation that have been documented in the 
literature include cramping, fullness, passing gas, bloating, diarrhea, fever, and blood in the 
stool. Since this is a research study, not all risks associated with fecal transplantation are 
known at this time; there may be unforeseen risks associated with study participation.  
 There are risks associated with colonoscopy: infection, bleeding, and less than 1% chance of 
a perforation or hole being created (A separate consent form for colonoscopy will be given 
on the day of fecal transplantation). 
 It’s possible your Crohn’s disease may progress or get worse after the transplantation. 
 When your blood is drawn, temporary pain and bruising where the needle enters the skin, 
and sometimes, fainting and/or infection.  
 There is a rare possibility that confidential information about you may be accidentally 
disclosed.  
 Some of the research that will be done on your blood are genetic studies. The genetic 
studies are only for research, and will not be used in making decisions about your care. We 
will not contact you about any results of these genetic studies.  
BENEFITS  
The following benefits may occur as a result of being in this study:  
The potential direct benefit of performing fecal microbiota transplantation for the treatment of 
Crohn’s Disease is improvement or resolution of symptoms associated with having inflammatory 
bowel disease, such as diarrhea, abdominal pain, fatigue, poor appetite, and minimizing the need 
for stronger medications that have their own associated side effects. 
The indirect benefits include contributions to our knowledge regarding the safety and tolerability of 
fecal microbiota transplantation. Additionally, by performing research studies examining the 
bacteria in your stool, as well as performing genetic studies, we hope to see if there is a link 
between genetics and colonic bacteria, as well as determine the relative abundance of each 
bacterium. This will also enable us to see if performing the stool transplant changed the 
composition of your stool and may one day lead to creating medications that increase healthy 
bacteria in the colon or target harmful bacteria. 
PAYMENT TO YOU  
You will not be paid for your participation in this study. This research might create new tests, 
treatment or cures. If it does, you will not get any money from those products.  
 
CONFIDENTIALITY  
We will take steps to help make sure that all the information we get about you is kept private. Your 
name will not be used wherever possible. We will use a code instead. All the study data that we get 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

                                                                                                                 Page 5 of 8 
 
from you will be kept locked up. The code will be locked up too. If any papers and talks are given 
about this research, your name will not be used.  
We want to make sure that this study is being done correctly and that your rights and welfare are 
being protected. For this reason, we will share the data we get from you in this study with the 
study team, Stony Brook University's Committee on Research Involving Human Subjects, applicable 
Institutional officials, and certain federal offices. However, if you tell us you are going to hurt 
yourself, hurt someone else, or if we believe the safety of a child is at risk, we will have to report 
this.  
This study requires that we collect very personal information about you. Therefore, we had the 
National Institutes of Health give us a Certificate of Confidentiality (COC). This piece of paper says 
that nobody can force the researchers to give out your information, even if a court of law asks for 
it. This will give you more protection. The only time information about you can be given out is:  
If you are going to hurt yourself  
If you are going to hurt someone else  
If we believe the safety of a child is at risk.  
If data about the fecal transplant needs to be reported to the Food and Drug Administration.  
If the data are required by other federal, state or local laws, such as for reporting of communicable 
diseases. 
You should know that the Certificate of Confidentiality does not apply to information about your 
participation in research, including a consent form that is placed in your medical record (though 
HIPAA protection does apply). This information may be disclosed to individuals requesting your 
medical record.  
This Certificate doesn’t mean you can’t talk about this study. If you give written permission, your 
insurance company, your boss, or your medical doctor can be given the research information too. 
While you are in this study we will get data about your health from your medical record. We will 
also get health data from the results of the tests you will have done in this study. You have a right 
to privacy but the data we get about your health in this study can be shared with the people 
referenced above (the study team, Stony Brook University's Committee on Research Involving 
Human Subjects, applicable institutional officials, and certain federal offices) as well as (as 
applicable):  
 Your private doctor  
 A board that reviews the safety of the study on an on-going basis  
Your health data are shared to make sure the study is being done correctly, costs are charged 
correctly, and to make sure your rights and safety are protected. Not all of these people are 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

                                                                                                                 Page 6 of 8 
 
required by law to protect your health data. They might share it with others without your 
permission. 
You have the right to stop allowing us to use or give out your health data. You can do this at any 
time by writing to Ellen Li, M.D. If you do this, we will stop collecting any new health data from you, 
except if we need to keep an eye on a bad side effect you were having in the study. We will use any 
data we collected before you wrote your letter. When you sign the consent form at the end, it 
means: 
 That you have read this section. 
 That you will allow the use and reporting of your health data as described above. 
 You have received a form from the University Hospital. It is called the Notice of Privacy 
Practices form. 
The Genetic Information Nondiscrimination Act (GINA): 
You should know that a federal law called the Genetic Information Nondiscrimination Act (GINA) 
generally makes it illegal for health insurance companies, group health plans, and most employers 
to discriminate against you based on your genetic information. This law will generally protect you 
in the following ways: 
§ Health insurance companies and group health plans may not request your genetic information 
from this research. 
§ If health insurance companies and group health plans do somehow receive your genetic 
information from this research, they may not use it to make decisions about your eligibility or 
premiums. 
§ Employers with 15 or more employees may not use your genetic information from this research 
when making a decision to hire, promote, or fire you when setting the terms of your employment. 
Be aware that this new law does not protect you against genetic discrimination by companies that 
sell life insurance, disability insurance, or long-term care insurance. 
 
COSTS TO YOU 
 If a colonoscopy is scheduled to perform the fecal transplant, we will obtain a prior 
authorization for colonoscopy to perform the transplant from your insurance company if 
needed. You may have to pay for a portion of the colonoscopy depending on your insurance 
plan. We encourage you to contact your insurance company to discuss this potential cost 
prior to consenting to be in the study. 
 All stool tests and blood work for research purposes will be performed without any cost to 
you for participating in this study. 
 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

                                                                                                                 Page 7 of 8 
 
ALTERNATIVES  
 
 An alternative to having the fecal microbiota transplantation is stepping up the medications 
you are currently on for your inflammatory bowel disease to immunomodulators and 
possibly biological agents such as Tumor Necrosis Factor - alpha antagonists, which carry 
their own risks.  
 The other alternative to performing the fecal microbiota transplantation is living with 
symptoms of Crohn’s Disease, such as bloody diarrhea, abdominal pain, fatigue, rashes, 
joint pains and other manifestations of inflammatory bowel disease.  
IN CASE OF INJURY  
If you are injured as a result of being in this study, please contact Dr. Ellen Li at telephone 
# 631-444-3460. The services of Stony Brook University Hospital will be open to you in case of such 
injury. However, you and/or your insurance company will be responsible for payment of any 
resulting treatment and/or hospital stay. 
CONSEQUENCES OF WITHDRAWING  
You may withdraw your consent at any time by contacting Dr. Ellen Li. If you do this, we will stop 
collecting any new health data from you for research purposes but will continue to use the data we 
collected prior to your withdrawal. Your choice will not at any time affect the commitment of your 
health care providers to administer care. There will be no penalty or loss of benefits to which you 
are otherwise entitled.  
YOUR RIGHTS AS A RESEARCH SUBJECT  
 Your participation in this study is voluntary. You do not have to be in this study if you don't 
want to be.  
 You have the right to change your mind and leave the study at any time without giving any 
reason, and without penalty.  
 Any new information that may make you change your mind about being in this study will be 
given to you.  
 You will get a signed and dated copy of this consent form to keep.  
 You do not lose any of your legal rights by signing this consent form.  
QUESTIONS ABOUT THE STUDY OR YOUR RIGHTS AS A RESEARCH SUBJECT 
If you have any questions, concerns, or complaints about the study, you may contact Dr. Ellen Li, at 
telephone # (631-444-3460).  
 If you have any questions about your rights as a research subject or if you would like to 
obtain information or offer input, you may contact the Stony Brook University Research 
Subject Advocate, Ms. Lu-Ann Kozlowski, BSN, RN, OR by e-mail, 
 lu-ann.kozlowski@stonybrook.edu.  
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

                                                                                                                 Page 8 of 8 
 
 Visit Stony Brook University’s Community Outreach page, 
http://research.stonybrook.edu/orc/community.shtml#overview-of-volunteering-in-
research for more information about participating in research, frequently asked questions, 
and an opportunity to provide feedback, comments, or ask questions related to your 
experience as a research subject. 
If you sign below, it means that you have read (or have had read to you) the information given in 
this consent form, and you would like to be a volunteer in this study. 
Please initial your response to each statement below.___________________________________  
 
1. I have been told about the risks, benefits, and alternatives to fecal microbiota transplantation, 
and I wish to undergo the procedure. 
Yes_____ No _____ 
 
2. I agree to follow-up via telephone so that the study investigators can evaluate my general well-
being for one year post-transplant. 
Yes_____ No _____ 
 
3. I agree to give a stool specimen 1-3 days prior to the fecal microbiota transplantation, 1 week 
post-transplant, and 3 months post-transplant for research. 
Yes_____ No _____ 
 
4. I agree to have my blood drawn on the day of fecal microbiota transplantation for research. 
Yes_____ No _____ 
 
 
_________________________________     ______________________________________________ 
Subject Name (Printed)  
 
            Subject Signature  
 
 
 
Date 
 
_________________________________     ______________________________________________ 
Name of Person Obtaining Consent              Signature of Person Obtaining Consent  
Date 
(Printed) 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

Page 1 of 4 
 
 
 
RECIPIENT RESEARCH ASSENT FORM  (CROHN’S) 
 
Project Title:  
 Fecal microbial transplantation in patients with Crohn’s disease  
Principal Investigator: Ellen Li, MD, PhD  
 
You are being asked to be in a research study.  
Purpose: To determine the safety and tolerability of fecal (stool) transplantation to treat Crohn’s 
Disease.  
What Will Be Done: If you decide to be in this study, your part will involve:  
 You will first have to choose somebody who will donate the stool which will be 
transplanted. The donor can be anyone who we will consent separately and meets eligibility 
criteria to donate stool. He/she will be asked questions and screened by performing 
bloodwork and stool studies to make sure he/she is a healthy candidate for stool 
transplantation.  
 After the donor is chosen and he/she meets criteria to donate stool, we will give you a date 
for the fecal transplantation. During the week before fecal transplantation, we will ask you 
to write down everything you have eaten on a diet record which we will provide to you. 
Stool will be collected 1-3 days before your day of fecal transplantation for research.  
 On the day before your transplant, you will be given instructions for a bowel prep to clean 
out your colon completely so it can be examined when we perform the fecal 
transplantation. For the last 7 hours before your scheduled fecal transplantation, you will 
have nothing to eat or drink.  
 On the day of the transplantation, you will arrive at Stony Brook University Hospital and go 
to the Endoscopy Suite, located on the 14th Floor. There you will change into a hospital 
gown and an intravenous line (IV) will be placed to provide you with fluids and sedation 
during the colonoscopy. Four teaspoons of blood will be taken for research, to perform 
genetic studies.  
 Your donor’s stool will be prepared and while you are properly sedated, the stool will be 
instilled into your colon. You will stay in the Endoscopy Suite, lying on your right side, for at 
least one hour. This is to maximize contact between the transplanted stool and your colon.   
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

Page 2 of 4 
 
If you are not cleared to depart after one hour, you will stay until the anesthesiologist 
(doctor who administered sedation during colonoscopy) does clear you to depart. You will 
be able to eat and drink right after you wake up and can resume normal activities as soon as 
the anesthesia wears off and you feel well.  
 You will receive a phone call the day after the procedure and be asked various questions to 
determine your general well-being.  
 You will then receive weekly phone calls for 12 weeks at a convenient time for you, to ask 
you further general well-being questions.  
 You will keep another diet record during the first week after the transplant. 1 week after 
your fecal transplantation you will collect stool for research, similar to how you collected 
stool prior to your stool transplantation.  
 You will keep another diet record during the 12th week after the transplant. 12 weeks after 
your fecal transplantation you will collect stool for research, similar to how you collected 
stool prior to your stool transplantation.  
 After 12 weeks, you will receive monthly phone calls until one year after the transplant to 
determine your general well-being.  
Costs to You:  
 You may have to pay for a portion of the colonoscopy, depending on your insurance plan. 
We encourage you to contact your insurance company to discuss this potential cost prior to 
consenting to be in the study.  
 Stool tests and bloodwork for research purposes will be performed without any cost to you 
for participating in this study.  
 
Payments to you: You will not be paid for your participation in this study.  
 
Risks/Discomforts:  
 Although donor stool is checked for bad germs, there is a still a small chance of an infection 
being passed from the donor’s stool to you.  
 Uncommon risks associated with fecal transplantation include cramping, fullness, gas, 
bloating, diarrhea, fever, and blood in the stool. Since this is a research study, not all risks 
associated with fecal transplantation are known at this time; there may be unknown risks 
associated with being in this study.  
 There are risks associated with colonoscopy: infection, bleeding, and less than a 1% chance 
of a perforation or hole being created (A separate consent form for colonoscopy will be 
given on day of fecal transplantation). 
  It’s possible your Crohn’s disease could get worse after the transplantation. 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

Page 3 of 4 
 
 When your blood is drawn, temporary pain and bruising where the needle enters the skin, 
and sometimes, fainting and/or infection.  
 There is a rare possibility that confidential information about you may be accidentally 
disclosed.  
 
Benefits: The potential direct benefits to you of having the fecal transplantation for treatment of 
Crohn’s Disease is improvement in your diarrhea, abdominal pain and symptoms associated with 
your Crohn’s Disease.  
The indirect benefits include increased knowledge regarding the safety and effectiveness of fecal 
transplantation. Additionally, by performing research studies examining the bacteria in your stool, 
as well as performing genetic studies, we hope to see if there is a link between genetics and colonic 
bacteria as well as determine the relative abundance of each bacteria. This will also help us see if 
performing the stool transplant changed the bacteria in your stool and may one day lead to 
creating medications that increase healthy bacteria in the colon or target harmful bacteria.  
In Case of Injury: If you are injured as a result of being in this study, please contact Dr. Ellen Li at 
telephone # 631-444-3460. The services of Stony Brook University Hospital will be open to you in 
case of such injury. However, you and/or your insurance company will be responsible for payment 
of any resulting treatment and/or hospital stay.  
Your Rights:  
 You do not have to be in this study if you don't want to be.  
 You have the right to change your mind and leave the study at any time without giving any 
reason, and without penalty.  
 Any new information that may make you change your mind about being in this study will be 
given to you.  
 You will get a signed and dated copy of this assent form to keep.  
 You do not lose any of your legal rights by signing this assent form.  
 
Questions:  
If you have any questions about this study, you can ask your parents, or talk to the study doctor, 
Dr. Ellen Li at 631-444-3460.  
If you want to talk to someone about whether or not you have to be in this study, or about other 
things about this study that you don’t want to talk over with your parents or the study doctor, you 
can call Ms. Lu-Ann Kozlowski, 631-632-9036, or e-mail her at lu-ann.kozlowski@stonybrook.edu.  
You can visit this webpage, 
http://research.stonybrook.edu/orc/community.shtml#overview-of-volunteering-in-research for 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

Page 4 of 4 
 
information about being in research studies. You can also ask questions or leave comments about 
how you feel about being a research subject in this study.  
If you sign below, it means that you have read this form and you would like to be in this study. 
  
Please initial your response to each statement below._________________________________  
 
1. I have been told about the risks, benefits, and alternatives to fecal transplantation, and I wish to 
undergo the procedure.  
Yes_____ No _____  
 
2. I agree to follow-up telephone calls for one year after the transplant so that the study 
investigators can evaluate my health.  
Yes_____ No _____  
 
3. I agree to give a stool specimen 1-3 days before the fecal transplantation, 1 week after the 
transplant, and 3 months after the transplant for research. 
Yes_____ No _____  
 
4. I agree to have my blood drawn on the day of fecal transplantation for research. 
Yes_____ No _____  
 
____________________________________        _____________________________     ______ 
Subject Name (Printed)  
 
 
       Subject Signature  
                          Date  
 
____________________________________        _____________________________     ______ 
Name of Person Obtaining Assent 
 
       Signature of Person Obtaining Assent     Date 
(Printed) 
 
 
 
 
 
      
 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

Page 1 of 6 
 
 
 
DONOR RESEARCH PERMISSION/CONSENT FORM  (CROHN’S) 
 
Project Title:    
 Fecal microbial transplantation in patients with Crohn’s disease 
Principal Investigator: Ellen Li, MD PhD 
Co-Investigator:  
 Anupama Chawla, MD 
  
Departments:  
 Medicine/Gastroenterology and Pediatric Gastroenterology & Nutrition 
 
When we say “you” in this consent form, we mean you or your child; “we” means the doctors and 
other staff. If you are a parent or legal guardian of a child who may take part in this study, 
permission from you is required and the assent (agreement) of your child may be required. 
You are being asked to be a volunteer in a research study. You are encouraged to take your time 
in making your decision. You may want to discuss this study with your friends and family. 
PURPOSE 
The purpose of this study is: 
 To determine the safety and tolerability of fecal (stool) transplantation to treat Crohn’s 
Disease. 
 Crohn’s Disease (CD) is a chronic disease affecting the colon, without a medical cure. The 
precise cause of having inflammatory bowel disease (IBD) such as Crohn’s disease, 
Ulcerative colitis, or indeterminate colitis is unclear. However, genetics and the 
environment are thought to play a role. Studies have found that patients with Crohn’s 
Disease have a decreased prevalence of protective bacteria and an increase in harmful 
bacteria in the colon. Inflammation in the colon in these patients is thought to be due to 
this imbalance between helpful and harmful bacteria. Currently, the treatment of IBD 
includes steroids, anti-inflammatory medications and biological therapy, each with its own 
side effects. Given the role of the gastrointestinal bacteria in driving inflammation in 
patients with IBD, treatments that manipulate these bacteria have been investigated, 
including the use of medications containing beneficial bacteria (probiotics), with some 
benefit. Fecal transplantation (FMT), the transfer of gastrointestinal bacteria (microbiota) 
from a healthy donor via infusion of a liquid stool suspension, is proving to be an effective 
alternative treatment for Crohn’s Disease. The treatment appeared to improve clinical 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

Page 2 of 6 
 
symptoms and lower inflammatory markers. The goal of this method is to remove the 
harmful bacteria in the colon and replace them with normal bacteria. 
 _______________________________(recipient’s name) has this condition and has named 
you as a potential stool donor so that the fecal transplantation can be performed. This study 
hopes to document fecal transplant’s safety and tolerability and improve or even eliminate 
___________________’s symptoms by performing the transplantation and then follow-up 
routinely with him/her for one year. 
 We will perform stool studies on you to see if the bacteria in your colon really did change 
the composition of ___________________’s colonic bacteria.  
We expect to enroll a minimum of 40 patients in this study at Stony Brook University Hospital. 
 
PROCEDURES 
If you decide to be in this study, your part will involve: 
 Answering a questionnaire to determine your eligibility to donate stool to the transplant 
recipient 
 If you are eligible, you will be asked to have stool testing and blood work done in a 
laboratory to evaluate for infectious agents that may theoretically be transferred to the 
recipient by your stool. 
 If all this testing is negative, then you and the stool recipient will be given a date for the 
stool transplant and you will be told to avoid ____________________________ (recipient 
allergen) for up to one week before the transplant. 
 During the week before fecal transplantation, we will ask you to record everything you have 
eaten on a diet record which we will provide to you.  
 On the night before or morning of fecal transplantation, you will be told to collect the stool 
using SaranTM Wrap, plastic hat, or a collection container. The stool will need to be collected 
prior to any contamination with the toilet bowl. The stool should then be kept in an airtight 
container which will be provided to you. 
 The stool may be kept at room temperature if used within 6 hours or kept in a refrigerator 
for up to 24 hours. Stool sample must not be frozen. 
 Stool is to be transported from the home to the hospital on ice packs. 
 On the day of transplant, you will come to Stony Brook University Hospital’s Endoscopy 
Suite, located on the 14th Floor, and drop off the stool.  You will be asked if you had a fever 
in the previous 2 weeks or accidentally ingested _____________ (recipient allergen) in the 
past week. 
When you are first recruited for the study, you will be assigned a coded number. Stool samples 
collected from you will have your coded number, so your information will not be directly linked to 
your samples, medical or diet diary information. 
 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

Page 3 of 6 
 
RISKS / DISCOMFORTS 
The following risks/discomforts may occur as a result of you being in this study: 
 When your blood is drawn, temporary pain and bruising where the needle enters the skin, 
and sometimes, fainting and/or infection. 
 As part of the study, blood work to test for HIV (the virus that causes AIDS), Hepatitis B, 
Hepatitis C, and Syphilis will be performed. If these tests come back as positive, the results 
will be discussed with you in a confidential manner. If you do test positive for HIV infection, 
the importance of telling your sex or needle-sharing partners of possible exposure will be 
discussed. 
 There is a rare possibility that confidential information about you may be accidentally 
disclosed. 
BENEFITS 
There is no direct benefit to you as a result of participating in this study. 
The potential indirect benefits include helping the recipient feel better. Indirect benefits also 
include contributions to our knowledge regarding the safety and tolerability of fecal microbiota 
transplantation. Performing research studies on your stool may enable us to see if performing the 
stool transplant changed the composition of the recipient’s stool and may one day lead to creating 
medications that increase healthy bacteria in the colon or target harmful bacteria. 
PAYMENT TO YOU 
You will not be paid for your participation in this study. This research might create new tests, 
treatment or cures. If it does, you will not get any money from those products. 
PAYMENT TO THE INSTITUTION 
This project has no outside funding. 
CONFIDENTIALITY 
Protecting Your Privacy in this Study 
We will take steps to help make sure that all the information we get about you is kept private. Your 
name will not be used wherever possible. We will use a code instead. All the study data that we get 
from you will be kept locked up. The code will be locked up too. If any papers and talks are given 
about this research, your name will not be used. 
We want to make sure that this study is being done correctly and that your rights and welfare are 
being protected. For this reason, we will share the data we get from you in this study with the 
study team, Stony Brook University's Committee on Research Involving Human Subjects, applicable 
Institutional officials, and certain federal offices. However, if you tell us you are going to hurt 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

Page 4 of 6 
 
yourself, hurt someone else, or if we believe the safety of a child is at risk, we will have to report 
this. 
This study requires that we collect very private information about you. Therefore, we had the 
National Institutes of Health give us a Certificate of Confidentiality (COC). This piece of paper says 
that nobody can force the researchers to give out your information, even if a court of law asks for 
it. This will give you more protection. The only time information about you can be given out is: 
If you are going to hurt yourself. 
If you are going to hurt someone else. 
If we believe the safety of a child is at risk. 
If data about the fecal transplantation needs to be reported to the Food and Drug Administration. 
If the data are required by other federal, state or local laws, such as for reporting of communicable 
diseases. 
You should know that the Certificate of Confidentiality does not apply to information about your 
participation in research, including a consent form that is placed in your medical record (though 
HIPAA protection does apply). This information may be disclosed to individuals requesting your 
medical record. 
This Certificate doesn’t mean you can’t talk about the study. If you give written permission, your 
insurance company, your boss, or your private doctor can be given the research information too. 
While you are in this study we will get health data from the results of the tests you will have done 
in this study. You have a right to privacy but the data we get about your health in this study can be 
shared with the people referenced above (the study team, Stony Brook University’s Committee on 
Research Involving Human Subjects, applicable institutional officials, and certain federal offices) as 
well as: 
 Your private doctor 
 A board that reviews the safety of the study on an on-going basis. 
Your health data are shared to make sure the study is being done correctly, costs are charged 
correctly, and to make sure your rights and safety are protected. Not all of these people are 
required by law to protect your health data. They might share it with others without your 
permission. 
You have the right to stop allowing us to use or give out your health data. You can do this at any 
time by writing to Ellen Li, MD. If you do this, we will stop collecting any new health data from you, 
except if we need to keep an eye on a bad side effect you were having in the study. We will use any 
data we collected before you wrote your letter. When you sign the consent form at the end, it 
means: 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

Page 5 of 6 
 
 That you have read this section. 
 That you will allow the use and reporting of your health data as described above. 
 You have received a form from the University Hospital. It is called the Notice of Privacy 
Practices form. 
COSTS TO YOU 
 You will be responsible for your stool and blood work for screening. Depending upon your 
insurance plan, the cost for this screening might not be covered and you may have to pay 
out of pocket for this process. We encourage you to contact your insurance company to 
discuss this potential cost prior to consenting to be in the study. 
 When you are approved to be the donor for the research study from your screening results, 
all stool tests thereafter for research purposes will be performed without any costs to you 
for participating in this study. 
 
ALTERNATIVES 
Your alternative to being in this study is to simply not participate. 
 
IN CASE OF INJURY 
If you are injured as a result of being in this study, please contact Dr. Ellen Li at telephone # 631-
444-3460. The services of Stony Brook University Hospital will be open to you in case of such injury. 
However, you and/or your insurance company will be responsible for payment of any resulting 
treatment and/or hospital stay. 
 
CONSEQUENCES OF WITHDRAWING 
You may withdraw your consent at any time by contacting Dr. Ellen Li. If you do this, we will stop 
collecting any new health data from you for research purposes but will continue to use the data we 
collected prior to your withdrawal. Your choice will not at any time affect the commitment of your 
health care providers to administer care. There will be no penalty or loss of benefits to which you 
are otherwise entitled. 
 
YOUR RIGHTS AS A RESEARCH SUBJECT 
 Your participation in this study is voluntary. You do not have to be in this study if you don't 
want to be. 
 You have the right to change your mind and leave the study at any time without giving any 
reason, and without penalty. 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

Page 6 of 6 
 
 Any new information that may make you change your mind about being in this study will be 
given to you. 
 You will get a signed and dated copy of this consent form to keep. 
 You do not lose any of your legal rights by signing this consent form. 
QUESTIONS ABOUT THE STUDY OR YOUR RIGHTS AS A RESEARCH SUBJECT 
 If you have any questions, concerns, or complaints about the study, you may contact Dr. 
Ellen Li at telephone # (631-444-3460). 
 If you have any questions about your rights as a research subject or if you would like to 
obtain information or offer input, you may contact the Stony Brook University Research 
Subject Advocate, Ms. Lu-Ann Kozlowski, BSN, RN,  (631) 632-9036, OR by e-mail, 
lu-ann.kozlowski@stonybrook.edu. 
 Visit Stony Brook University’s Community Outreach page, 
http://research.stonybrook.edu/orc/community.shtml#overview-of-volunteering-in-
research for more information about participating in research, frequently asked questions, 
and an opportunity to provide feedback, comments, or ask questions related to your 
experience as a research subject. 
 
If you sign below, it means that you have read (or have had read to you) the information given in 
this consent form, and you would like to be a volunteer in this study. 
Please initial your response to each statement below._____________________________________  
 
1. I have been told about the risks, benefits and alternatives to being screened for fecal microbiota 
transplantation, and I wish to be a donor. 
Yes_____ No _____ 
 
2. I agree to give a stool specimen on the day of the fecal microbiota transplantation for research. 
     
Yes_____ No _____ 
 
_________________________________     ______________________________________________ 
Subject Name (Printed)  
 
           Subject Signature 
 
 
 
Date 
 
_________________________________    ______________________________________________ 
Name of Person Obtaining Consent             Signature of Person Obtaining Consent 
Date 
(Printed) 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

Page 1 of 3 
 
 
 
DONOR RESEARCH ASSENT FORM   (CROHN’S) 
 
Project Title: Fecal microbial transplantation in patients with Crohn’s disease 
Principal Investigator: Ellen Li, MD PhD 
 
You are being asked to be in a research study. 
Purpose: To determine the safety and tolerability of fecal (stool) transplantation to treat Crohn’s 
Disease 
 
 What Will Be Done: If you decide to be in this study, your part will involve:  
 Answering a questionnaire to see if you are able to donate stool to the transplant recipient  
 If you are eligible, you will be asked to have stool testing and blood tests done in a 
laboratory to see if you have harmful germs that might be transferred to the recipient by 
your stool. About 2-3 teaspoons of blood will be drawn from your arm vein for the blood 
tests.  
 If all this testing is negative, then you and the stool recipient will be given a date for the 
stool transplant and you will be told to avoid _______________________ (recipient 
allergen) for up to one week before the transplant.  
 During the week before fecal transplantation, we will ask you to record everything you have 
eaten on a diet record which we will provide to you.  
 On the night before or morning of fecal transplantation, you will be told to collect the stool 
using SaranTM Wrap, plastic hat, or a collection container. The stool will need to be collected 
before any contamination with the toilet bowl. The stool should then be kept in an airtight 
container which we will give you.  
 The stool may be kept at room temperature if used within 6 hours or kept in a refrigerator 
for up to 24 hours. Stool sample must not be frozen.  
 Stool is to be transported from the home to the hospital on ice packs. 
 On the day of transplant, you will come to Stony Brook University Hospital’s Endoscopy 
Suite, located on the 14th Floor, where you will drop off the stool and be asked if you had a 
fever in the previous 2 weeks or accidentally ate _____________ (recipient allergen) in the 
past week.  
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

Page 2 of 3 
 
Costs to You:  
You may have to pay for the screening stool and blood tests, depending on your insurance plan. We 
encourage you or your parent/guardian to contact your insurance company to discuss this before 
you agree to be in the study.  
 
Payments to you: You will not be paid for being in this study.  
 
Risks/Discomforts:  
 When your blood is drawn, temporary pain and bruising where the needle enters the skin, 
and sometimes, fainting and/or infection.  
 As part of the study, blood work to test for HIV (the virus that causes AIDS), Hepatitis B, 
Hepatitis C, and Syphilis will be performed. If these tests come back as positive, the results 
will be discussed with you. If you do test positive for HIV infection, the importance of telling 
your sex or needle-sharing partners of possible exposure will be discussed.  
 There is a rare possibility that confidential information about you may be accidentally 
disclosed.  
 
Benefits: There is no direct benefit to you as a result of participating in this study.  
 
The potential indirect benefits include helping the recipient feel better. Indirect benefits also 
include helping us learn more about the safety and effectiveness of fecal transplantation. 
Performing research studies on your stool may help us find out if performing the stool transplant 
changed the bacteria in the recipient’s stool and may one day lead to creating new medications 
that increase healthy bacteria in the colon or target harmful bacteria.  
 
In Case of Injury: If you are injured as a result of being in this study, please contact Dr. Ellen Li at 
telephone # 631-444-3460. The services of Stony Brook University Hospital will be open to you in 
case of such injury. However, you and/or your insurance company will be responsible for payment 
of any resulting treatment and/or hospital stay.  
 
Your Rights:  
 The fact that you are in this study will be kept a secret.  
 You do not have to be in this study if you do not want to be.  
 You can change your mind at any time and leave the study without any problem and 
without telling us why.  
 If we find out anything that may make you change your mind about being in this study, we 
will tell you.  
 
Questions:  
If you have any questions about this study, you can ask your parents, or talk to the study doctor, 
Dr. Ellen Li at 631-444-3460.  
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)

Page 3 of 3 
 
If you want to talk to someone about whether or not you have to be in this study or about other 
things about the study that you do not want to talk over with your parents or the study doctor, you 
can call Ms. Lu-Ann Kozlowski, 631-632-9036, or e-mail her at lu-ann.kozlowski@stonybrook.edu.  
 
You can visit this webpage,  
http://research.stonybrook.edu/orc/community.shtml#overview-of-volunteering-in-research 
for information about being in research studies. You can also ask questions or leave comments 
about how you feel about being a research subject in this study.  
 
If you sign below, it means that you have read this form and you would like to be in this study. 
 
Please initial your response to each statement below._________________________________  
 
1. I have been told about the risks, benefits, and alternatives to being screened for stool 
transplantation, and I wish to be a donor.  
 
Yes_____ 
 No _____  
 
 
2. I agree to give a small part of my stool specimen on the day of the stool transplantation for 
research. 
  
 
Yes_____  
No _____  
 
 
______________________________ 
______________________________     _______ 
Subject Name (Printed)  
 
 
Subject Signature  
 
 
        Date  
 
 
______________________________  
______________________________     _______  
Name of Person Obtaining Assent  
 
Signature of Person Obtaining Assent        Date 
(Printed) 
Approved: July 3, 2019
Expiration Date: February 13, 2020
Stony Brook University IRB (CORIHS B)