Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea
Phase: PHASE1
Conditions: Recurrent C. Difficile Associated Diarrhea
Sponsor: The University of Texas Health Science Center, Houston

Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
Page 1 
Revised 12/15/2016 
IRB NUMBER: HSC-SPH-13-0119 
IRB APPROVAL DATE: 03/15/2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for 
Multiple Recurrent C. Difficile Associated Diarrhea 
 
NCT02318992 
 
Version Date: 3/15/2017 
 
 

Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
Page 2 
Revised 12/15/2016 
IRB NUMBER: HSC-SPH-13-0119 
IRB APPROVAL DATE: 03/15/2017 
 
 
Clinical Study Protocol 
A STUDY OF FECAL MICROBIOTA TRANSPLANTATION FOR THE TREATMENT OF RECURRENT C. 
DIFFICILE ASSOCIATED DIARRHEA (CDAD) 
 
Study Number: UT-SPH-FMT-0001 
Study Phase 1 
Investigational Product 
Fresh Healthy Donor Fecal Bacteria 
Frozen Healthy Donor Fecal Bacteria 
Lyophilized Healthy Donor Fecal Bacteria 
 
 
 
Sponsor 
The University of Texas Health Science Center 
 
Houston, TX 77030 
 
Principal Investigators: 
Dr. Herbert L. DuPont – responsible for review and evaluation of information relevant to the safety of the study 
product 
Professor and Director, 
Center for Infectious Diseases 
UT-SPH 
|||||||||||||||||||||||||||||||||||||||||||||||||||| 
Houston, TX 77030 
Ph: 713 500 9366 
Email:  Herbert.l.dupont@uth.tmc.edu 
 
Dr. Zhi-Dong Jiang – responsible for monitoring the conduct and progress of the clinical investigations and 
preparing the fecal bacteria for transplantation 
Associate Professor 
Center for Infectious Diseases 
UT-SPH 
|||||||||||||||||||||||||||||||||||||||||||||||||||| 
Houston, TX 77030 
Ph: 713 500 9371 
Email:  zhi-dong.jiang@uth.tmc.edu 
 
Dr. Andrew DuPont 
Associate Professor 
University of Texas Medical School at Houston 
Department of Internal Medicine, Gastroenterology 
|||||||||||||||||||||||||||||||||||||||||||||||||||| 
Houston, TX 77030 
Ph:  713 500 6687 
Email:  Andrew.dupont@uth.tmc.edu 

Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
Page 3 
Revised 12/15/2016 
IRB NUMBER: HSC-SPH-13-0119 
IRB APPROVAL DATE: 03/15/2017 
 
 
 
 
TABLE OF CONTENTS 
 
SYNOPSIS ........................................................................................................................................................ 4 
1. ETHICS .................................................................................................................................................... 10 
2. INTRODUCTION ...................................................................................................................................... 10 
2.1 Background ............................................................................................................................................... 10 
2.2 Current Treatment of C. difficile Associated Diarrhea (CDAD) and Recurrent CDAD (RCDAD) ................. 10 
2.4 Summary of Fecal Microbiota Transplantation ........................................................................................... 11 
3. OBJECTIVE ............................................................................................................................................. 11 
4. STUDY DESIGN ...................................................................................................................................... 11 
4.1 Study Structure .......................................................................................................................................... 12 
4.2 Study Population ....................................................................................................................................... 12 
4.3 Study Procedures ...................................................................................................................................... 13 
4.3.1 Informed Consent ............................................................................................................................ 13 
4.3.2 Identification Number ....................................................................................................................... 13 
4.3.3 Inclusion and Exclusion Criteria ....................................................................................................... 13 
5. METHODOLOGIES.................................................................................................................................. 14 
5.1 Recipient ................................................................................................................................................... 14 
5.1.1 
Pre-screening ............................................................................................................................. 14 
5.1.2 
One day before fecal microbial transplantation ........................................................................... 15 
5.1.3 
Day of fecal microbial transplantation ......................................................................................... 15 
5.1.4 
One day after fecal microbial transplantation .............................................................................. 15 
5.1.5 
Seven days after fecal microbial transplantation......................................................................... 16 
5.1.6 
Fourteen days after fecal microbial transplantation..................................................................... 16 
5.1.7 
Thirty days after fecal microbial transplantation .......................................................................... 16 
5.1.8 
Safety data ................................................................................................................................. 17 
5.2 Donor ........................................................................................................................................................ 17 
5.2.1 
Pre-screening ............................................................................................................................. 17 
5.2.2 
One day before transplantation .................................................................................................. 18 
5.2.3 
Day of fecal microbial transplantation ......................................................................................... 18 
6 
EVALUATION OF SAFETY ...................................................................................................................... 18 
6.1 Primary Safety Endpoints .......................................................................................................................... 19 
6.1.1 
Medical conditions ...................................................................................................................... 19 
6.1.3 
Monitoring for safety ................................................................................................................... 20 
6.1.4 
Pre-existing signs and symptoms and medical conditions .......................................................... 21 
6.1.5 
Progression of underlying conditions as an adverse experience................................................. 21 
6.1.6 
Recording and documenting adverse experience ...................................................................... 21 
6.1.7 
Investigator reporting of serious adverse experience................................................................. 22 
6.1.8 
Notification of post-study serious adverse experience ................................................................ 22 
6.2 Secondary efficacy endpoint ...................................................................................................................... 22 
7 
DATA COLLECTION AND ANALYSIS ..................................................................................................... 23 
7.1 
Recording of data.................................................................................................................................. 23 
7.2 
Statistical Methods ................................................................................................................................ 23 
7.2.1 
General considerations............................................................................................................... 23 
7.2.2 
Power calculations ..................................................................................................................... 23 
7.2.3 
Analysis Populations .................................................................................................................. 23 
7.2.4 
Randomization procedures......................................................................................................... 23 

Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
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IRB NUMBER: HSC-SPH-13-0119 
IRB APPROVAL DATE: 03/15/2017 
 
 
 
7.2.5 
Analyses of safety ...................................................................................................................... 24 
7.2.6 
Secondary efficacy analyses ...................................................................................................... 24 
8. 
PROTECTING PRIVACY .................................................................................................................... 24 
9 
CONTACTS ........................................................................................................................................ 25 
10. 
REFERENCES ..................................................................................................................................... 25 

Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
Page 5 
Revised 12/15/2016 
IRB NUMBER: HSC-SPH-13-0119 
IRB APPROVAL DATE: 03/15/2017 
 
 
 
SYNOPSIS 
TITLE 
A study of fecal microbiota transplantation (FMT) for the treatment of recurrent C. difficile 
associated diarrhea (CDAD) 
PROTOCOL 
UT-SPH-FMT-0001 
SETTINGS 
Attending physicians of recipients/patients will recommend the FMT and make clinical 
decisions related to overall health of his/her patients. All patients undergoing therapy will 
be handled as outpatients at either Baylor St. Luke‟s Medical Center, the Digestive 
Disease Center at Memorial Hermann, or Kelsey-Seybold Clinic – Main Campus on 
Holcombe Blvd. 
OBJECTIVE 
To evaluate the safety of FMT (fresh, frozen or lyophilized health donor feces) for the 
treatment of patients with 3 or more recurrent C. difficile associated diarrhea (CDAD) 
STUDY DESIGN 
Allocation: Randomized 
Endpoint Classification: Safety Study 
Intervention Model: Parallel Assignment 
Masking: Open Label 
Primary Purpose: Treatment 
INCLUSION 
CRITERIA - 
RECIPIENT 
All recipients 
1.  Male and female patients ≥ 18 years of age 
2.  Sexually active male and female patients of child-bearing potential must agree to 
use an effective method of birth control during the treatment and follow-up period 
3.  Female patients of child-bearing potential must have a negative pregnancy test in 
the 72 hours before the procedure 
4.  Required to sign an informed consent form 
5.  Deemed likely to survive for ≥ 3 months after enrolment 
6.  Diagnosis of ≥ 3 recurrent CDAD (RCDAD) bouts in outpatients or ≥ 2 bouts of 
CDAD in an inpatient without other explanation for diarrhea and with ≥ 2 positive 
fecal tests for C. difficile toxin 
7.  Referred by subjects attending physician who will provide non-transplant care for 
the subject 
8.  Received at least one course of adequate antibiotic therapy for CDAD (≥ 10 days 
of vancomycin at a dose of ≥125 mg four times per day, ≥ 10 days of 
metronidazole at a dose of 500mg three times per day or fidaxomixin 200mg 
twice a day for 10 days 
9.  Anti-CDI antibiotic treatment or probiotics stopped approximately 2 days before 
the transplantation 
INCLUSION 
CRITERIA - DONOR 
1. 
Able to provide and sign informed consent. 
2. 
Able to complete and sign the donor questionnaire 
3. 
Able to adhere to fecal transplantation stool collection requirements 
EXCLUSION 
CRITERIA - 
RECIPIENT 
1.  Patients with neutropenia with absolute neutrophil count <0.5 x 109/L 
2.  Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray 
3.  Peripheral white blood cell count > 15.0 x 109/L AND temperature > 38.0 °C 
4.  Active gastroenteritis due to Salmonella, Shigella, E. coli 0157:H7, Yersinia or 

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IRB APPROVAL DATE: 03/15/2017 
Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
 
 
 
 
Campylobacter, and Norovirus 
5.  Presence of colostomy 
6.  Unable to tolerate HBT for any reason 
7.  Requiring systemic antibiotic therapy for more than 7 days 
8.  Actively taking Saccharomyces boulardii or other probiotic 
9.  Severe underlying disease such that the patient is not expected to survive for 
more than 3 months or unstable medical condition requiring daily change in 
treatments. 
EXCLUSION 
CRITERIA - DONOR 
1. 
Test positive for any of variables 
2. 
History of any type of active cancer or autoimmune disease 
3. 
History of risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, 
prion or any neurological disease as determined by the donor questionnaire 
4. 
History of gastrointestinal disorder, e.g., inflammatory bowel disease, irritable 
bowel syndrome, chronic constipation or diarrhea 
5. 
Antibiotic use or any systemic immunosuppressive agents in the 3 months prior 
to stool donation 
6. 
Receipt of any type of live vaccine within 3 months prior to stool donation 
7. 
Current or previous medical or psychosocial condition 
8. 
Body mass index over 30 
SCREENING OF 
DONOR 
Stool will be tested for the following enteric pathogens: 
1.   Shigella 
2.   Salmonella 
3.   Campylobacter 
4.   Shiga-toxin Producing Escherichia coli 
5.   Clostridium difficile Toxin A/B 
6.   Parasites (Cryptosporidum, Entamoeba histolytica, Giardia) only if the donor has 
travelled to developing regions in past month 
Blood sample from donor will be tested for following items: 
1.  Hepatitis B core antibody 
2.  Hepatitis B surface antigen 
3.  Hepatitis C virus antibody 
4.  HIV-1 and HIV-2 antibody 
5.  Anti-HTLV I/II 
6.  Serologic test for syphilis 
DONOR STOOL 
PREPARATION 
Stool preparation will be started on the transplantation day: 
1. 
Donor stool will be used within 1 month after the screening process 
2. 
Obtain ≥ 150 grams of stool from a qualified donor requiring collection of 
multiple stools 
3. 
Mix  with  1500mL  (1:10  dilution)  sterilized  0.9%  NaCl  without  antibacterial 
preservative in a large sterilized suction canister 
4. 
Mix above solution in a homogenizer mixer with sterilized bag (Stomacher). 

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Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
 
 
 
 
Initially, use the low setting until the sample breaks up, and then advance the 
speed gradually to the highest setting.  Continue for 2 – 4 minutes until sample 
is smooth. 
5. 
Filter the suspension using a sterile paper coffee filter (or gauze) that has been 
moistened with saline and funnel (both are sterilized). Allow adequate time for 
slow filtration to end. NOTE: To expedite process, multiple funnel/filters can be 
used to combine product. 
6. 
Repeat step 4. NOTE: it may take 2 hours to complete steps 4 and 5. 
7. 
The resultant filtered suspension will be placed in sterilized 50 mL tubes 
8. 
Number the samples as FMT-D-001-FRESH (5 tubes), FMT-D-001-FROZEN 
(5 tubes) and FMT-D-001-LYOPHILIZED (5 tubes) 
9. 
Label the container with lot number (mm-dd-yyyy), donor ID, and date and time 
processed 
10. 
Keep the samples - 
 
FMT-D-001-FROZEN   (5 tubes) sealed with plastic (polyethylene or 
similar film) at -80C for up to 6 months in a test tube rack clearly labelled 
with the media lot # and expiration date 
 
FMT-D-001-LYOPHILIZED (5 tubes) – 
   Start  lyophilisation  within  30  minutes  after  completion  of  stool 
filtration 
   Keep lyophilized samples at -80C for up to 6 months in a test tube 
rack clearly labelled with the media lot # and expiration date 
 
FMT-D-001-FRESH (5 tubes) transferred to Endoscopy procedure site 
immediately for the same day FMT. The fresh donor stool will be used 
for FMT within 8 hours after collection. 
11. 
If necessary, repeat stool donors who are perceived to be safer than the first 
time donors. If the repeat donor is used within 1 month and passes the 
questionnaire survey, no blood or stool will be screened. If the donor has not 
been screened in the last month, the donor will repeat the medical history 
survey, and both blood and stool will be tested again for all tests listed under 
Screening of Donor Section above before donating again. 
STUDY SCHEDULE 
Before FMT: 
 
Potential donors are screened at the CLIA certified laboratory 
 
Eligible recipients stop other antibiotics and use oral vancomycin 125 mg 
four times a day for approximately 4 days before FMT which is stopped 
approximately 2 days before the procedure. 
 
Informed consent (Patient Consent Form) is given to the patient along 
with (Patient Info Provided with Consent). 
 
Patient completes daily diary – symptoms (Patient Data Collection Form) 
 
Discuss and provide letter to patient (Patient Letter - Aftercare of FMT) 
 
Send letter to patient‟s physician (Physician Letter - Before FMT). 
 
Obtain stool specimen for C. difficile toxin test and an aliquot of stool 
frozen (-80oC) for future studies. 

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IRB APPROVAL DATE: 03/15/2017 
Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
 
 
 
 
Two donors will be contacted and informed about stool donation. We will 
provide all necessary supplies to the donors for stool collection the next 
day. 
 
Donor is encouraged to take one stool softener laxative the evening 
before the procedure and drink of plenty water. 
 
Recipients who will receive the FMT by colonoscopy will take a bowel 
lavage with 4 litters of colonoscopy prep the night before FMT (ordered by 
study gastroenterologist or subjects private MD) 
 
Recipients will complete Daily diary 
 
Obtain stool specimen for C. difficile toxin test and store an aliquot of stool 
at -80o C for future studies. 
Day of FMT: 
 
 
Donor stool must be to the Enteric Pathogen Diagnostic Laboratory at the 
University of Texas School of Public Health (EPDL-UT-SPH) within two 
hours of passing. 
 
Donor‟s stool will be processed according to the protocol Section 5.2.3.1. 
The donor stool process will take 2-3 hours. 
 
Donor stool suspension (at least 250 mL after dilution of stool) will be 
delivered to the Endoscopy procedure site in a cooler with wet ice by an 
employee from EPDL-UT-SPH approximately thirty minutes before 
scheduled procedure time. 
 
Recipient will receive 250mL of filtered healthy donor stool (≥ 50 g stool) 
by colonoscopy 
 
Recipient completes daily diary  (Patient Data Collection Form) 
 
After FMT procedure the recipient will be given instructions to manage 
mild diarrhea after FMT, what to do if diarrhea recurs, etc. (Patient letter - 
Aftercare of FMT) 
 
The first week after FMT: 
 
Recipient will be contacted to determine health status 
 
Subjects will return to the clinic or be contacted via telephone/email 
 Patient Completes daily diary – symptoms  (Patient Data Collection Form) 
 Investigator or study coordinator assesses compliance with the 
transplantation 
 
Approximately seven days after transplantation (depending on their availability, 
weekends and holidays): 
 
 
Recipient will either return to the clinic or be contacted via 
telephone/email 
 
Daily diary will be completed by participant (Patient Data Collection Form) 
and returned 
 
Recipient will provide stool specimen for C. difficile toxin test and an 
aliquot of stool frozen (-80oC) for future studies. 
 
Assess compliance with study requirements 

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IRB APPROVAL DATE: 03/15/2017 
Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
 
 
 
 
Approximately fourteen Days after transplantation (depending on their availability, 
weekends and holidays): 
 
Participant will either return to the clinic or be contacted via 
telephone/email 
 
Daily diary will be completed (Patient Data Collection Form) 
 
Recipient will provide stool specimen for C. difficile toxin test and an 
aliquot of stool frozen (-80oC) for future studies. 
Approximately thirty days after transplantation (depending on their availability, weekends 
and holidays): 
 
Participant will either return to the clinic or be contacted via 
telephone/email 
 
Daily diary will be completed (Patient Data Collection Form) 
 
Recipient will provide stool specimen for C. difficile toxin test and an 
aliquot of stool frozen (-80oC) for future studies. 
 
A letter to patient‟s physician (Physician letter – FMT Complete) 
ASSESSMENTS 
Demographic Data/History of C. difficile Infection 
Demographic data (gender, race, date of birth, medical history, medication in the past 6 
months, onset of diarrhea and signs or symptoms of gastrointestinal tract, any C. difficile 
toxin test performed in the past 6 months) will be recorded approximately 4 days before 
transplantation. 
Clinical Laboratory Tests 
Stool samples will be collected for C. difficile toxin tests less than 10 days before FMT 
and approximately 7, 14 and 30 days after FMT (depending on their availability, 
weekends and holidays). 
Patient Diaries 
Each recipient will receive a patient diary card at time of enrolment. Diary card will be 
collected at the approximate time intervals: -4 day, -1 day, day 0, day 1, day 7, day 14 
and day 30 after the procedure with day 0 being the date of transplantation (depending 
on their availability, weekends and holidays).  Recipient will record the following 
parameters daily: 
 
Date, time and consistency of each stool 
 
Presence or absence and severity of signs or symptoms of enteric infection, 
including fever, gas, nausea, abdominal cramp/pain, tenesmus) in each 24 hours 
 
Date, time and description of adverse event 
 
Date, time, name and dose of any other medication administered 
DURATION OF 
FOLLOWUP 
The duration of study participation for each patient is approximately 34 days (4 days 
before and 30 days after transplantation) depending on their availability, weekends and 
holidays. We will attempt to follow up subjects on or about 6 months after FMT in order 
to monitor any health effects for safety. 

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IRB APPROVAL DATE: 03/15/2017 
Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
 
 
 
STUDY 
POPULATION 
Recipient: 
100 adult male or female patients with ≥ 3 RCDAD as outpatients or ≥ 2 RCDAD while in 
the hospital having completed a course of vancomycin or fidaxomicin. 
Donor: 
20 potential donors will be identified to provide stools of ≥ 50 g each (total ≥ 150 g). 
STUDY AGENT, 
DOSE & MODE OF 
ADMINISTRATION 
Filtered feces (250mL, either Fresh or Frozen or Lyophilized sample) from a screened 
healthy donor will be administered by colonoscopy 
EFFICACY 
EVALUATION 
   Primary Endpoint: Safety of fecal transplantation (Fresh or Frozen or Lyophilized) 
   Secondary Endpoint: Failure to have a subsequent bout of CDAD in 30 days post 
FMT 
SAFETY 
EVALUATION 
Safety will be assessed by evaluating any unfavorable or unintended sign, symptom, or 
disease temporally associated with FMT procedure will be recorded as adverse 
experience. We will also collect information about the frequency and/or severity of the 
signs or symptoms of enteric infection (defined as fever, moderate to severe 
gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, or 
defecation urgency). We will attempt to follow subjects on or about 6 months after FMT 
to obtain information about recurrence or any adverse effects. 

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IRB APPROVAL DATE: 03/15/2017 
Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
 
 
 
1.  ETHICS 
The study is reviewed, approved and conducted in accordance with regulations mandated by the 
University of Texas Health Science Center at Houston institutional review board. In addition, the study 
will be conducted with the College of American Pathologists standards that meet regulations relating to 
Good Clinical Practice (GCP). These standards respect the following guidelines: 
 
1.  GCP: Consolidated Guideline (International Conference on Harmonization [ICH] of Technical 
Requirements for the Registration of Pharmaceuticals for Human Use, May 1996). 
2.  United States (US) Code of Federal Regulations (CFR) dealing with clinical studies (21 CFR Parts 
50, 54, 56, 312, 314, and 511) [1]. 
3.  Declaration of Helsinki, concerning medical research in humans (“Recommendations Guiding 
Physicians in Biomedical Research Involving Human Patients,” Helsinki 1964, amended Tokyo 
1975, Venice 1983, Hong Kong 1989 and revised version of Somerset West, Republic of South 
Africa, October, 1996, Note of Clarification added by the WMA [World Medical Association] General 
Assembly, Washington 2002, Note of Clarification added by the WMA General Assembly, Tokyo 
2004. 
 
2.  INTRODUCTION 
 
2.1 Background 
 
In the United States and Canada there has been an alarming increase in the incidence and severity 
of CDAD in the last decade. It is now estimated that between 500,000 and 700,000 cases of CDAD 
occur in U.S hospital annually with an estimated hospital excess cost of care of about 3.2 billion 
dollars [2, 3]. With the increased risk of developing CDAD, high rates of disease recurrence are 
being seen without the availability of adequate treatment [4, 5]. Inflammatory Bowel Disease 
refractory to conventional treatment remains a major clinical problem [6, 7]. 
 
It is now accepted that the disruption of the normal balance of colonic microbiota secondary to 
antibiotic use facilitates the development of CDAD and improvements in the quality and quantity of 
flora is associated with recovery of infection and disease recurrence. Studies have shown that 
patients with recurrent CDAD have decreased anaerobic bacteroidetes and alteration of counts of 
firmicutes in their stool compared to patients recovering from single episodes of CDAD [8]. 
Numerous case reports and retrospective case series have demonstrated the benefit of fecal 
microbiota transplantation (FMT) in patients with severe or recurrent CDAD with cure rates over 
90% [9-13]. FMT involves administration of a suspension of feces obtained from a healthy individual 
into the colon of a patient with recurrent CDAD to promote normalization of flora and inhibition of 
the infecting C. difficile [10]. Probiotics have been used widely for patients with CDAD in efforts to 
repair the disruption of microbiota leading to prevention and control of CDAD [14]; however, the 
available probiotics have been shown to have a limited effect failing to reach the efficacy of fecal 
transplantation from a healthy volunteer. 
 
2.2 Current Treatment of C. difficile Associated Diarrhea (CDAD) and Recurrent CDAD (RCDAD) 
 
The administration of vancomycin, metronidazole or fidaxomycin is the first choice for antibiotic 
therapy for CDAD especially for severe clinical illness defined as the presence of important 
comorbidity, altered sensorium, unstable clinical course, confinement in an intensive care unit, renal 

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University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
 
 
 
failure (creatinine level ≥ 1.5 times the upper limit of normal), reduced serum albumin level (<2.5 
g/dL), hypotension, or leukocytosis with a white blood cell count greater than 15,000/mm3 [19]. 
 
A unique feature of CDAD is the very high recurrence rate seen in 25% of patients treated with 
equivalent frequency with either metronidazole or vancomycin [20, 21], typically beginning 7 to 14 
days after therapy is completed for the first bout. Primary treatment of CDI with fidaxomicin reduces 
the rate of recurrence to 15% for infection caused by non-NAP1 strains [22]. A meta-analysis of 39 
studies, including 11 prospective, 21 retrospective and 7 randomized clinical trials showed that 
there was 22% treatment failure for metronidazole versus 14% for vancomycin. Recurrence rates 
were 27% for metronidazole and 24% for vancomycin [23]. In smaller case reports, tigecycline [24], 
rifaximin [25], and nitazoxanide [26] showed response rates of 86%, 79% and 74% respectively for 
refractory CDAD. Fidaxomixin has been showed to be the same value as vancomycin with regard to 
cure rate but was associated with a significantly lower recurrence rate [22]. 
 
2.3 Summary of Fecal Microbiota Transplantation 
 
Given the unacceptable failure rate of antibiotic treatment and in particular recurrence with standard 
therapy, alternative treatment approaches have been explored for those who have failed standard 
antibiotic therapy. Once the balanced gastrointestinal bacteria are disturbed by antibiotics, C. 
difficile has the opportunity to grow due to the loss of the normal bacterial population. Fecal 
transplantation is a strategy that restores the diversity of the gut microflora, which may confer 
protection against toxigenic C. difficile [8, 10]. FMT recreates the normal fecal microbiota, allowing 
the inhibition of C. difficile [32]. In addition, there is a possibility that the transplantation of healthy 
flora results in an immunological response, facilitating the elimination of C. difficile. Fecal 
transplantation treatment was introduced with the first reported case in 1958 by Eiseman et al. [33]. 
Over the subsequent 55 years, promising reports of FMT have suggested a ~90% clinical cure rate 
for recurrent CDAD [34]. More recent studies in 2012 confirmed these numbers with cure rates of 
86% to 94% [35-38]. These results indicate that fecal transplantation for RCDAD is significantly 
superior to those with conventional antibiotic therapy. However, using fresh donor stool has its 
practical barriers, such as difficulty in stool preparation, and standardization of donor stool. It has 
been proposed to use frozen fecal extracts in the transplantation [36]. FMT needs to be a 
standardized and simplified to optimize the process and make it more efficient. 
 
A description of the Fecal Microbial Transplantation (FMT) is available to physicians and patients 
(Introduction to FMT) 
 
3.  OBJECTIVE 
 
We will generate a frozen, lyophilized or fresh FMT inoculum from well-screened healthy volunteer donors of 
≥150 gram/sample. Delivery of FMT will be performed colonoscopically. This study will evaluate the safety of 
a frozen or lyophilized or fresh inoculum administered by colonoscopy.  Fecal samples from donors and 
recipients will be saved for future studies. 
 
4.  STUDY DESIGN 
 
This is a single center, randomized, parallel assignment, open label safety study conducted in patients 
with RCDAD. Approximately 100 patients will be enrolled in the study and randomized at 1:1 ratio to 
receive fresh or frozen or lyophilized donor stool. 

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IRB APPROVAL DATE: 03/15/2017 
Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
 
 
 
 
4.1 Study Structure 
 
 
Donors will be enrolled and screened at the Center for Infectious Disease laboratory for enteric 
pathogens at University of Texas School of Public Health (EPDL-UT-SPH) which is CAP and CLIA 
certified laboratory.  The donors will come from a variety of places, including the University of Texas 
School of Public Health. 
 
Recipients All patients to be treated must have a physician who is willing to care from them after 
discharge from our facility. Recipients will need to have insurance or be willing to self-pay for this 
therapy. Attending physician of recipients/patients will order the FMT and make clinical decisions 
related to overall health for his/her patients. All patients undergoing therapy will be handled as 
outpatients at either Baylor St. Luke‟s Medical Center in the Texas Medical Center, the Digestive 
Disease Center at Memorial Hermann in the Texas Medical Center, or Kelsey-Seybold Clinic – 
Main Campus on Holcombe Blvd. Once the procedure is completed, the recipient will be transferred 
back to their original medical treatment facility or be released to home care under the care of their 
physician. A gastroenterologist with privileges at Endoscopy procedure site will perform the FMT via 
colonoscopy. The Center for Infectious Disease enteric pathogens laboratory at the University of 
Texas School of Public Health will prepare donor stool for administration via a colonoscopy. 
 
Evaluation of the safety and recurrence clinical symptoms of FMT will be performed by the primary 
physicians and research coordinators from the EPDL-UT-SPH. The primary endpoint is to evaluate 
the safety of the FMT (fresh or frozen or lyophilized health donor feces) for the treatment of patients 
with 3 or more RCDAD. A second efficacy endpoint is to evaluate the recurrence of clinical 
symptoms after initial therapy.  In order to monitor any health effects for safety, participants will be 
contacted on or about 6 months following FMT procedure. 
 
4.2 Study Population 
 
Our recent study demonstrated that a majority of Houston gastroenterologists and infectious 
diseases specialists supported the creation of a fecal microbiota transplantation center in Houston 
[39]. The recipients with RCDAD will be referred generally by gastroenterologists and infectious 
diseases specialists or other physicians. We will screen at least 120 recipients and 70 donors. One 
Hundred recipients with RCDAD will be included in the study using the following entry criteria. 
 
Subject will be referred by his or her attending physician who will provide non-transplant care for the 
subject. 
 
Volunteer donors from the University of Texas School of Public Health will provide stools for use for 
the 100 patients. The donors will not be compensated. Volunteers may provide stools for more than 
one patient. The donors must not be students or lab technicians working at EPDL-UT-SPH. The 
donors will be screened and surveyed for health and medication use, sexual behavior, travel, and 
other risk factors for infectious diseases during a private and confidential interview (Donor – 
Prescreen Form).  All fecal material from donors will be tested/ screened for enteric pathogens 
mentioned in protocol section 4.3.3. Donors will be notified by an email in the event an infection is 
identified. 

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Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
 
 
 
 
4.3 Study Procedures 
 
4.3.1 Informed Consent 
 
Written informed consent must be obtained from each recipient (Patient Consent Form) or donor 
(Donor Consent Form) before he/she undergoes any procedures required by this protocol, 
including screening procedures. Informed consent forms may be emailed to recipients and 
returned by E-mail or fax. 
 
4.3.2 Identification Number 
 
Recipient:  Each patient who signs an informed consent form will be assigned a study number at 
the clinic. The study number will consist of the letter „FMT-R-XXX‟ followed by a 3 digit 
identification number (e.g., FMT-R-001). Recipients need to meet the inclusion and 
exclusion criteria (listed below in table). 
 
Donor: Every donor who signs an informed consent form will be assigned a screening number at 
the EPDL-UT-SPH. Subjects must be screened before they can become a qualified 
donor. The screening number will consist of the letter „FMT-D-‟ followed by a 3 digit 
identification number (e.g., FMT-D-001). This will be the only ID for this donor. Donors 
will provide stool volume within 2 hours to EPDL on the FMT day. The stools will be 
accepted if they are ≥ 150 g. Stools of lower weight (≤ 150g but ≥ 50g) will be used as 
fresh product only, no frozen and lyophilized transplantation product will be saved. We 
will collect an additional stool from the same donor within one month screened for frozen 
and lyophilized transplantation products. 
 
4.3.3 Inclusion and Exclusion Criteria 
 
Inclusion Criteria 
Exclusion Criteria 
Recipients 
1.  Male and female patients ≥ 18 years of age 
2.  Sexually active male and female patients of 
child-bearing potential must agree to use an 
effective method of birth control during the 
treatment and follow-up period 
3.  Female patients of child-bearing potential 
must have a negative pregnancy test in the 72 
hours before the procedure 
4.  Required to sign an informed consent form 
5.  Deemed likely to survive for ≥ 3 months after 
enrolment 
6.  Diagnosis of ≥ 3 recurrent CDAD (RCDAD) 
bouts in outpatients or ≥ 2 bouts of CDAD in 
an inpatient without other explanation for 
diarrhea and with ≥ 2 positive fecal tests for C. 
difficile toxin 
7.  Referred by subjects attending physician who 
will provide non-transplant care for the subject 
8.  Received at least one course of adequate 
1.  Patients with neutropenia with 
absolute neutrophil count <0.5 x 
109/L 
2.  Evidence of toxic megacolon or 
gastrointestinal perforation on 
abdominal x-ray 
3.  Peripheral white blood cell count > 
15.0 x 109/L AND temperature > 
38.0 °C 
4.  Active gastroenteritis due to 
Salmonella, Shigella, E. coli 
0157:H7, Yersinia or 
Campylobacter, and Norovirus 
5.  Presence of colostomy 
6.  Unable to tolerate HBT for any 
reason 
7.  Requiring systemic antibiotic 
therapy for more than 7 days 
8.  Actively taking Saccharomyces 

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Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
 
 
 
 
antibiotic therapy for CDAD (≥ 10 days of 
vancomycin at a dose of ≥125 mg four times 
per day, ≥ 10 days of metronidazole at a dose 
of 500mg three times per day or fidaxomixin 
200mg twice a day for 10 days 
9.  Anti-CDI antibiotic treatment or probiotics 
stopped 2-4 days before the transplantation 
boulardii or other probiotic 
9.  Severe underlying disease such 
that the patient is not expected to 
survive for more than 3 months or 
unstable medical condition 
requiring daily change in 
treatments 
Donors 
1.   Able to provide and sign informed consent 
2.   Able to complete and sign the donor 
questionnaire 
3.   Able to adhere to fecal transplantation stool 
collection requirements 
1.   Test positive for any of variables 
2.   History of any type of active cancer 
or autoimmune disease 
3.   History of risk factors for acquisition 
of HIV, syphilis, Hepatitis B, 
Hepatitis C, prion or any 
neurological disease as determined 
by the donor questionnaire 
4.   History of gastrointestinal disorder, 
e.g., inflammatory bowel disease, 
irritable bowel syndrome, chronic 
constipation or diarrhea 
5.   Antibiotic use or any systemic 
immunosuppressive agents in the 3 
months prior to stool donation 
6.   Receipt of any type of live vaccine 
within 3 months prior to stool 
donation 
7.   Current or previous medical or 
psychosocial condition 
8. 
Body mass index over 30 
 
 
5.  METHODOLOGIES 
 
5.1 Recipient 
 
5.1.1 Pre-screening 
 
Prior to procedure recipient will be screened with a screening log that is compliant with local 
regulations regarding patient confidentiality. The screening log will be designed to document the 
rationale for screening the patient (inclusion criteria) and not enrolling the patient (exclusion 
criteria, patient declined to participate). The information will be obtained from the Pre-screening 
(Recipient Prescreen Form) and then further evaluated if pre-qualified obtaining more detailed 
medical History (Recent Medical History Form). The investigator will record all patients 
screened for the study in the screening log, even if they do not sign an informed consent form. 
However, patients must sign an informed consent form before any study procedures are 
performed on the patient. Following documents will be obtained: 

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University of Texas School of Public Health 
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Clinical Study Protocol: UT-SPH-FMT-0001 
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 
Informed consent 
 
Patient demographics and medical history 
 
Letters to be sent: 
 
 
Patient letter – Aftercare of FMT 
 
Physician letter – Physician Letter - Before FMT 
 
CDAD is defined as ≥ 3 loose or watery stools per day for at least 2 consecutive days or ≥ 8 
loose or watery stools within 48 hours and with positive C. difficile toxin. Recurrent CDAD 
(RCDAD) is defined as the reappearance of either a symptom or a positive toxin assay within 60 
days of the treatment. Antimicrobial agents will be discontinued approximately 2 days before the 
treatment. Recipient will stop any other antibiotics. A fresh stool sample will be collected from a 
recipient, tested for C. difficile toxins and an aliquot (2 mL) saved at -80C for future studies 
before FMT. 
 
If appropriate subjects will visit a study gastroenterologist for evaluation before planned 
colonoscopy or duodenal intubation. 
 
 
 
5.1.2 One day before fecal transplantation 
 
For FMT by colonoscopy bowel Preparation will take place 24 hours before FMT as prescribed 
by gastroenterologist. 
 
A fresh stool sample will be collected from a recipient, tested for C. difficile toxins and an aliquot 
(2 mL) saved at -80C for future studies. 
 
 
 
5.1.3 Day of Fecal transplantation 
 
Recipient cannot consume any solid food, alcohol or any liquids on the day of FMT. Each 
patient should have completed the informed consent (Patient - Consent Form). The 
gastroenterologist will insert 250mL of filtered stool into the colon by colonoscopy. 
 
A fresh stool sample will be collected from a recipient before FMT, and approximately 7, 14, and 
30 days after FMT, tested for C. difficile toxins and an aliquot (2 mL) stored at -80C for future 
studies. (Patient Letter – Aftercare of FMT) A letter will be provided to the recipient indicating 
the need to avoid antibiotics in the next few months, to take a probiotic (Saccharomyces 
boulardii) if an antibiotic is needed and to consume foods that feed the intestinal bacteria such 
as bananas, nuts, oat or bran, root vegetables and flaxseeds and what is recommended if their 
diarrhea recurs. 
 
5.1.4 During the first week after fecal transplantation 
 
 
 
The recipient will be contacted by the investigator approximately 24 hours after the procedure is 
performed. The following procedures will be completed: 

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Review recipient diary with the recipient to ensure that the following information is recorded 
correctly and collect the completed pages: 
 
   Date and time of the procedure completed 
   Date, time and any adverse experience and/or name of dosage of any medication 
   Presence or absence and severity of signs or symptoms of any adverse experience 
 
 
 
5.1.5 Approximately Seven days after fecal transplantation (depending on their availability, 
weekends and holidays) 
 
 
The recipient will be contacted by the investigator approximately 7 days after the procedure is 
performed. The following procedures will be completed: 
 
Review recipient diary with the recipient to ensure that the following information is recorded 
correctly and collect the completed pages: 
   Date and time of the procedure completed 
   Date, time, and any adverse experience and/or name of dosage of any medication 
   Presence or absence and severity of signs or symptoms of any adverse experience 
   A fresh stool sample will be collected from recipient, tested for C. difficile toxins and 
an aliquot (2 mL) stored at -80C for future studies. 
 
 
5.1.6 Approximately Fourteen days after fecal transplantation (depending on their 
availability, weekends and holidays) 
 
 
The recipient will be contacted by the investigator approximately 14 days after the procedure is 
performed. The following procedures will be completed: 
 
Review recipient diary with the recipient to ensure that the following information is recorded 
correctly and collect the completed pages: 
   Date and time of the procedure completed 
   Date, time, and any adverse experience and/or name of dosage of any medication 
   Presence or absence and severity of signs or symptoms of any adverse experience 
   A fresh stool sample will be collected from recipient, tested for C. difficile toxins and an 
aliquot (2 mL) stored at -80C for future studies. 
 
 
5.1.7 Approximately Thirty days after fecal transplantation (depending on their availability, 
weekends and holidays) 
 
 
The recipient will be contacted by the investigator approximately 30 days after the procedure 
is performed. The following procedures will be completed: 
 
Review recipient diary with the recipient to ensure that the following information is recorded 
correctly and collect the completed pages: 
   Date and time of the procedure completed 
   Date, time, and any adverse experience and/or name of dosage of any medication 

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Clinical Study Protocol: UT-SPH-FMT-0001 
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   Presence or absence and severity of signs or symptoms of any adverse experience 
   A fresh stool sample will be collected from recipient, tested for C. difficile toxins and an 
aliquot (2 mL) stored at -80C for future studies. 
   After 30 days a letter will be sent to you indicating that you have successfully completed 
the study and that all future medical issues should be handled by your non-FMT 
physician. 
 
 
5.1.8 Safety data 
 
 
 
We will attempt to contact recipients on or about 6 months following FMT in order to monitor any 
health effects for safety. 
 
5.1.9 Treatment Failure 
 
Treatment failure occurs when a new episode of C Difficille occurs which includes > three plus 
watery diarrhea episodes per day and a positive C. Difficile toxin test.  A letter will be sent to the 
patient‟s physician relaying this information (Physician Letter – Treatment Failure) 
 
5.2 
Donor 
 
 
Project investigator/coordinator from the University of Texas School of Public Health will be 
responsible for donor positive identification. They will walk the donor with a FMT number and date 
of birth to the blood center at CHI St. Luke‟s Medical Center. An employee from blood center will 
draw the donor in the presences of the University of Texas School of Public Health 
investigator/coordinator and label tubes with FMT # and date of birth provided. 
 
5.2.1 Pre-screening 
 
 
Approximately 70 potential donors may need to be pre-screened to allow recruitment of at 
least 20 qualified donors (Donor – Prescreen Form). Identified donors will be found from 
various employees without direct patient contact, except students and lab technicians in 
EPDL-UT-SPH. Before a stool is used for transplantation, the donor will be screened for 
infectious diseases using the following tests. 
 
Stool will be collected in a semi-sterilized container.  Stool needs to be delivered to the 
Laboratory for EPDL-UT-SPH in room 
 within 8 hours after collection. Every fecal 
donation will be tested for enteric pathogens, including Shigella, Salmonella, 
Campylobacter, Shiga-toxin Producing Escherichia coli, Clostridium difficile Toxin A/B. 
 
Blood samples from the donor will be collected with a sterilized needle (25mL blood will be 
collected) at the St. Luke‟s Medical Center Blood Bank and tested for conditions screened 
for blood transfusions including Hepatitis B core Antibody, Hepatitis B Surface Antigen, 
Hepatitis C virus Antibody, HIV-1 and HIV-2 Antibody, Anti-HTLV I/II, Serologic Test for 
Syphilis 

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University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
 
 
5.2.2 One day before transplantation 
 
 
 
Investigator will contact qualified donors to have at least 2 donors who would be able to 
provide ≥ 50 grams of stool on the day of FMT for fresh FMT. 
 
Donor are encouraged to take one stool softener laxative the evening before the procedure 
and drink of plenty water. 
 
We will provide the supplies and instructions for sample collection. 
 
 
5.2.3 Day of Fecal transplantation 
 
 
5.2.3.1 
Donor Stool Preparation, Storage and Shelf Life 
 
 
 
1.  Obtain ≥ 150g of stool per transplant (multiple stools will be required to obtain ≥150 
grams). When the randomization calls for a fresh sample ≥ 50 g of stool will be 
accepted and used in totality not more than 4 hours before procedures 
2.  Stools of lower weight (≤ 150g but ≥ 50g) will be used as fresh FMT only, no frozen 
and lyophilized transplantation product will be saved. We will collect additional stool 
from the same donor during the month screened for frozen and lyophilized 
transplantation products. 
3.  Donor stool is mixed with 1500mL (1:10 dilution) sterilized 0.9% NaCl without 
antibacterial preservative in a large sterilized suction canister 
4.  The solution is mixed in a homogenizer mixer with sterilized bag (Stomacher). Initially, 
use the low setting until the sample breaks up, and then advance the speed gradually 
to the highest setting. Continue for 2 – 4 minutes until sample is smooth. 
5.  The suspension is filtered using a sterile paper coffee filter (or gauze) that has been 
moistened with saline and funnel (both are sterilized). Allow adequate time for slow 
filtration to end. NOTE: To expedite process, multiple funnel/filters can be used to 
combine product. 
6.  Repeat step 4. NOTE: it may take 2 hours to complete steps 4 and 5. 
7.  Place filtered suspension in 15 sterilized 50 mL tubes 
8.  Number the samples as FMT-D-001-FRESH (5 tubes), FMT-D-001-FROZEN  (5 
tubes) and FMT-D-001-LYOPHILIZED (5 tubes) (Form 129-12-03) 
9.  Label the tubes with lot number (mm-dd-yyyy) and date and time processed 
10. Keep the samples - 
 
FMT-D-001-FROZEN (5 tubes) sealed with plastic (polyethylene or similar 
film) at -80C in room 
 for up to 6 months in a test 
tube rack clearly labelled with the media lot # and expiration date (6 months 
after preparation date) 
 
FMT-D-001-LYOPHILIZED (5 tubes) – 
   Start lyophilisation within 30 minutes after completion of stool filtration 
   Keep lyophilized samples at -80C in room 
 for 
up to 6 months in a test tube rack clearly labelled with the media lot # and 
expiration date (6 months after preparation date) 

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EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 

FMT-D-001-FRESH (5 tubes) transferred to SLMC Endoscopy Unit 
 
 
immediately for the same day FMT. The fresh donor stool will be used for 
FMT within 8 hours after collection. 
11. Upon completion of the process, stool samples must be recorded into the Donor 
Specimens Log (Form #131-12-05) 
12. Repeat stool donors will be used for three or more recipients. We consider donors 
having safely provided fecal bacteria to other recipients safer than first time donors. If 
the repeat donor stool is used within 1 month of passing the questionnaire survey, no 
blood and stool will be screened. If the donation is over 1 month of the before mentioned 
process, then the medical history must filled out again and both blood and stool will be 
screened/tested as listed in Screening Of Donor section of protocol. 
 
5.2.3.2 
Prepare for Transplantation 
 
 
1.  Center for Fecal Transplantation will notify EPDL-UT-SPH 10 days before the 
procedure about potential patients by Email (Zhi-Dong.Jiang@uth.tmc.edu). 
2.  Center for Fecal Transplantation will confirm the details about the procedure 24 hours 
before the transplantation with EPDL-UT-SPH Email (Zhi-Dong.Jiang@uth.tmc.edu). 
3.  On the procedure day, ≥250mL of suspension will be delivered to the hospital Micro- 
Laboratory in a cooler with wet ice by an employee from EPDL-UT-SPH Email (Zhi- 
Dong.Jiang@uth.tmc.edu). 
 
 
 
6 
EVALUATION OF SAFETY 
 
 
6.1 
Primary Safety Endpoints 
 
The following safety endpoints will be evaluated in this study. 
 
6.1.1 
Medical conditions 
 
 
Clinical improvement is monitored by telephone and or E-mail during 30 days after FMT. 
Minor clinical management of the subject with over the counter medication (e.g. 
loperamide, acetaminophen and Saccharomyces boulardii [probiotic]) will be performed 
in the case of mild diarrhea and abdominal pain. 
 
All subjects will be followed up by phone the day after FMT to assess health status during 
week one. Study subjects will be monitored on approximately days 7, 14 and 30 after 
FMT, at which time we will review the recipient diary with the recipient to review any 
adverse experience or medication taken since the medical history obtained at FMT.  In 
order to monitor any health effects for safety, participants will be contacted on or about 6 
months following FMT. 
 
Investigators should determine if any adverse experience or medication need to be 
further studied. Donor will be contacted and tested if it is necessary. All actions will be 

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recorded on with medical condition, dates of adverse experience and medication taken, 
indication for new medication taken, and total daily dose (Patient Data Collection Form). 
 
Recipients should be instructed at FMT to contact the Investigator if they have any 
questions regarding adverse experience or the appropriateness of a medication after 
FMT. 
 
6.1.2 
Monitoring for safety 
 
 
The following definitions of terms are guided by the International Conference of 
Harmonization and US Code of Federal Regulations (21 CFR 312.32). 
 
An adverse experience is any unfavorable or unintended sign, symptom, of disease 
temporally associated with FMT procedure, whether or not considered related to the 
procedure, including, but not limited to: 
 
Any symptom not previously reported by the recipients (Recent Medical History) 
 
An exacerbation of a pre-existing illness, increases in the frequency and/or 
severity of the signs or symptoms of CDAD (defined as positive C. difficile toxin 
test and enteric symptoms) 
 
A significant increase in frequency or intensity of a pre-existing episodic event or 
condition 
 
A condition first detected or diagnosed after study drug administration even 
through the condition may have been present before the procedure 
 
Details of all adverse experiences that occur after FMT through approximately day 30 
visit will be collected as indicated above. 
 
Serious adverse experience is any adverse experience that: 
 
Results in death 
 
Is life threatening (at immediate risk of death from the procedure as it occurred) 
 
Requires inpatient hospitalization (overnight stay) or prolongs a current 
hospitalization 
 
Causes a persistent or significant disability/incapacity 
 
Medical important (any event that requires medical or surgical intervention to 
prevent one of the outcomes listed above) 
 
The investigator will exercise medical and scientific judgment when deciding whether 
expeditious reporting is appropriate in other situations not strictly meeting the listed 
criteria above. The investigators will meet/discuss with experts in the field if there is a 
question of whether the adverse experience would be considered serious. 
 
Severity – The adverse experience will be documented on the appropriate page in the 
Patient Diary according to the following descriptors: 
 
Mild: associated with no limitation of usual activities or only slight discomfort 
 
Moderate: associated with limitation of usual activities or significant discomfort 

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 
Severe: associated with inability to carry out usual activities or very marked 
discomfort 
 
Relationship – the relationship of adverse experience to FMT will be assigned by the 
Investigator according to the following definitions: 
 
Probable: a reaction that follows a reasonable temporal sequence from the 
procedure that follows a known or expected response pattern to the suspected 
procedure and that could not be reasonably explained by the known characteristics 
of that patient‟s clinical state 
 
Possible: a reaction that follows a reasonable temporal sequence from the 
procedure that follows a known or expected response pattern to the procedure but 
could readily have been produced by a number of other factors 
 
Unlikely: a reaction that does not follow a reasonable temporal sequence from the 
procedure but for which causality from FMT cannot be ruled out. 
 
Not related: a reaction for which sufficient data exist to indicate that the etiology is 
unrelated to the procedure 
 
 
6.1.4 Pre-existing signs and symptoms and medical conditions 
 
 
Medical conditions that are present at or before the procedure that manifest with the 
same severity or frequency will not be recorded as adverse experience. Similarly, signs 
or symptoms related to a pre-existing disease will not be recorded as adverse 
experience unless there is an increase in the severity or frequency of the signs or 
symptoms. These pre-existing conditions, signs, or symptoms will be recorded on the 
Recent Medical History Form. 
 
6.1.5 Progression of underlying conditions as an adverse experience 
 
 
If the progression of the underlying condition might be reasonably anticipated given the 
nature and severity of the underlying condition, then the progression of the underlying 
condition per se will not constitute an adverse experience. However, if the progression of 
the underlying condition is fatal, then the progression of the underlying condition should 
be reported as an adverse experience. 
 
6.1.6 
Recording and documenting adverse experience 
 
 
The Investigator must completely and promptly record each new adverse experience and 
serious adverse experience, even if the relationship of adverse experience to the 
procedure is assessed by the Investigator to be “unlikely” or “not related”. In addition, the 
investigator must document and follow serious adverse experiences that occur from the 
procedure through 30 days after the FMT. The Investigator should attempt, if possible, to 
establish a diagnosis based on the presenting signs and symptoms. If an adverse 
experience meets the definition of a serious adverse experience then the Investigator 
must also complete the serious adverse experience, and also send any supporting 

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source documents directly to the University of Texas Health Science Center IRB as soon 
as the event is discovered. At each visit, after the patient has had an opportunity to 
mention any problems spontaneously, the Investigator (or designee) will inquire about 
adverse experience by asking the standard questions listed in, such as: 
 
 
Have you had any medical problems since your last visit? 
 
Have any medical problems present at your last visit changed, i.e., stopped, 
worsened, or improved? 
 
Have you taken any new medicines, other than study drug, since your last visit? 
 
Any spontaneous adverse experience information provided by the patient will be 
reported. If an adverse experience has not resolved at the time of the Final Visit (day 30 
Visit), the Investigator should evaluate the status of the adverse experience at the 
Follow-Up telephone/email contact and update to reflect the status of the adverse 
experience (e.g. ongoing or resolved). 
 
6.1.7 
Investigator reporting of serious adverse experience 
 
 
All serious adverse experience must be reported to the University of Texas Health 
Science IRB using the serious adverse experience facsimile or email or by 
telephone/email as soon as the serious adverse experience is discovered, and within 24 
hours after the Investigator recognizes or classifies the event as a serious adverse 
experience. A brief description of the event must be provided at the time of the initial 
serious adverse experience report. The initial serious adverse experience report should 
be followed up by additional information using the serious adverse experience within 48 
hours. The reports should identify the patient by their unique patient number instead of 
names. The completed serious adverse experience Form will be used by the 
investigators in regulatory filings. The investigator is responsible for continuing to report 
to the University of Texas Health Science IRB any new or relevant follow-up information 
obtained concerning the serious adverse experience. The results of any additional 
assessments conducted must be also reported to the University of Texas Health Science 
IRB. 
 
6.1.8 Notification of post-study serious adverse experience 
 
 
Investigators are not obligated to actively seek follow-up information for patients with 
adverse experience after the conclusion of the study (i.e., > 30 days after the FMT 
procedure). However, if the investigator becomes aware of an adverse experience that 
occurs after the patient completes and the adverse experience is considered by the 
Investigator to be at least possibly related to study procedure, the investigator must 
notify the University of Texas Health Science Center IRB. 
 
6.2 Secondary efficacy endpoint 
7 
The secondary endpoint is failure to have a subsequent bout of CDAD in 30 days post FMT. It is 
defined as recipient has had another episode of diarrhea (≤3 unformed stools in 24 hours) with 

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EPDL-UT-SPH-FMT-001 
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positive C. difficile toxin A/B test. An unformed stool is defined as either a soft or watery stool. 
Data will be recorded in the CRFs.  Patients will be asked to seek further medical treatment with 
their primary physicians. No further FMT will be performed. 
 
 
 
8 
DATA COLLECTION AND ANALYSIS 
 
 
7.1 
Recording of data 
 
 
The Investigator must maintain adequate and accurate source documents. The source 
documents will be reviewed and signed at the investigative site by the investigators periodically. 
 
7.2 
Statistical Methods 
 
 
7.2.1 General considerations 
 
 
All analyses will be performed and all tables, figures, and data listings will be prepared 
using SAS (Cary, NC). Summary statistics for continuous variables will include the 
mean, standard deviation, median, minimum, and maximum value; categorical 
variables will be presented as counts and percentages. For all analyses, baseline is 
defined as the date of fecal transplantation. 
 
7.2.2 Power calculations 
 
 
No power calculation was performed since this is a pilot study. We will evaluate the 
program/center after enrollment of 100 recipients with RCDAD. Thirty patients (33 in 
each group, receive either fresh or frozen or lyophilized stools from healthy donors) 
with CDAD will be included in the study using the entry criteria in section 4.3.3. 
 
7.2.3 Analysis Populations 
 
 
All analyses will be conducted using the intent-to-treat population. Intent-to-treat is 
defined as all recipients who have started the procedure. 
 
Listings and summary tables with descriptive statistics will be prepared for 
demographic data (gender, date of birth, race/ethnicity), and medical history data 
(including the date and time of onset of CDAD and signs or symptoms of enteric 
infection, episodes of RCDAD). 
 
7.2.4 Randomization procedures 

Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
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Revised 12/15/2016 
IRB NUMBER: HSC-SPH-13-0119 
IRB APPROVAL DATE: 03/15/2017 
 
 
 
An independent statistician will develop a randomization list using SAS. Randomization 
in permuted blocks will be used to achieve balance across treatment groups. The 
randomization scheme consists of a sequence of blocks such that each block contains 
a pre-specified number of treatment assignments in random order. The purpose of this 
is to balance the randomization scheme at the completion of each block. The target 
sample size is100 recipients (33 receive fresh, 33 receive frozen and 33 receive 
lyophilized stool), blocks of size 3 are natural. Subject study identification assignment 
log will be completed and kept in the study binder. 
 
7.2.5 Analyses of safety 
 
 
All adverse experience and serious adverse experience will be coded using the Medical 
Dictionary for Regulatory Activities Version 12.0 which is a registered trademark of the 
International Federation of Pharmaceutical Manufacturers and Associations. The 
number and percentage of patients reporting at least one occurrence of adverse 
experience and/or serious adverse experience for each system organ class and 
preferred term will be tabulated. Term will also be tabulated by severity and by the 
relationship to the procedure. For multiple occurrences of the same adverse experience 
with different severities, the adverse experience with the highest severity will be 
tabulated. For multiple occurrences of the same adverse experience with different 
relationships to the procedure (related and not related); the adverse experience will be 
tabulated as related. All adverse experience and or serious adverse experience for all 
patients will be presented in data listings. Narratives will also be prepared for each 
serious adverse experience. 
 
Physical examination findings will be presented in data listings. Listings and summary 
tables with descriptive statistics will be prepared for each vital sign parameter (diastolic 
and systolic blood pressure, heart rate, oral temperature, respiratory rate). In addition, 
the percent change from baseline will be calculated for each continuous variable. 
 
7.2.6 Secondary efficacy analyses 
 
The proportion of patients in each group (fresh, frozen and achieving Clinical Cure will 
be compared using the Chi-square test. The proportion of recipients with a subsequent 
bout of CDAD in 60 days post FMT in each treatment group will be compared using the 
Chi-square test. 
 
8 PROTECTING PRIVACY 
 
 
This study protocol, documentation data, and all other information generated, will be held in strict 
confidence by the Investigators. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval by the investigators. 

Enteric Pathogens Diagnostic Laboratory 
University of Texas School of Public Health 
EPDL-UT-SPH-FMT-001 
Clinical Study Protocol: UT-SPH-FMT-0001 
Page 25 
Revised 12/15/2016 
IRB NUMBER: HSC-SPH-13-0119 
IRB APPROVAL DATE: 03/15/2017 
 
 
 
9   CONTACTS 
 
 
 
Dr. Herbert L. DuPont at 832-355-4122. 
 
The University of Texas Health Science Center Committee for the Protection of Human Subjects at 
(713) 500-7942. 
 
The CHI St. Luke‟s Medical Center Institutional Review Board at (832) 355-3347 
 
 
10 
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