Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis

Inclusion Criteria:

1. Patients > 18 years of age

2. The patient has been treated with appropriate antimicrobial therapy for CDI.

3. The patient has documented relapse/recurrence of infection as demonstrated by
positive stool culture, or cytotoxin assay, or PCR toxin assay.

4. Since this study does not involve treatments that have potential teratogenicity, and
in general avoidance of antimicrobial treatment during pregnancy is advised
(metronidazole is pregnancy category C), women of child-bearing age may be included
in the study.

Exclusion Criteria:

- Patients will be excluded from study participation if one of the following categories of
exclusion criteria applies:

1. Patient is < 18 years of age

2. Patient has an absolute neutrophil count < 750 cells/mm3.

Stool donors must:

1. be > 18 years of age

2. Complete a screening questionnaire:

a. One-time donors: Table 1 b. Designated, pre-screened donors: Table 2

3. Be tested for communicable blood-borne and enteric pathogens:

1. One-time donors: Table 3

2. Designated, pre-screened donors: Table 4

Table 1: Questionnaire to screen one-time stool donors prior to FMT.

You have been identified as a potential stool donor by __________________ , your (spouse/
son/ daughter/ mother/ father/ life partner), who has been referred for fecal
transplantation. Prior to performing the transplantation procedure, the OSF/Saint Francis
Medical Center Infection Control Committee requires completion of a screening
questionnaire by all potential stool donors:

Your name: ___________________________________________ Date: ___/___/ 2013

Your relationship to the patient: ___________________________ YES / NO

1. Have you ever been diagnosed with Clostridium difficile colitis?

2. Are you currently taking antibiotic medications?

3. Have you been prescribed antibiotics in the past six weeks?

IF the potential stool donor answers YES to questions 1, 2, or 3 - please STOP.

Do you have a history of any of the following: (Please Circle)

Hepatitis A YES / NO Hemophilia YES / NO Hemodialysis treatment YES / NO Rejected or
refused blood donation YES / NO HIV/AIDS YES / NO Hepatitis B YES / NO Hepatitis C YES /
NO Use of intravenous drugs or medications YES / NO Incarceration YES / NO Abnormal blood
tests of liver enzymes YES / NO Accepting money or drugs in exchange for sex YES / NO
Receipt of a blood transfusion between 1977 - 1992 YES / NO Infectious gastroenteritis or
diarrhea YES / NO

Did you answer YES to any of the above? YES / NO

Table 2: Questionnaire to screen designated stool donors prior to each FMT.

You have been identified as a potential stool donor for a patient who has been referred to
Saint Francis Medical Center for fecal transplantation. Prior to performing the
transplantation procedure, the OSF/Saint Francis Medical Center Infection Control
Committee requires completion of a screening questionnaire by all potential stool donors:

Your name: ___________________________________________ Date: ___/___/ 2013

Your relationship to the patient: ___________________________ YES / NO

1. Have you ever been diagnosed with Clostridium difficile colitis?

4. Are you currently taking antibiotic medications?

5. Have you been prescribed antibiotics in the past six weeks?

IF the potential stool donor answers YES to questions 1, 2, or 3 - please STOP.

Do you have a history of any of the following: (Please Circle)

Hepatitis A YES / NO Hemophilia YES / NO Hemodialysis treatment YES / NO Rejected or
refused blood donation YES / NO HIV/AIDS YES / NO Hepatitis B YES / NO Hepatitis C YES /
NO Use of intravenous drugs or medications YES / NO Incarceration YES / NO Abnormal blood
tests of liver enzymes YES / NO Accepting money or drugs in exchange for sex YES / NO
Receipt of a blood transfusion between 1977 - 1992 YES / NO Infectious gastroenteritis or
diarrhea YES / NO

Did you answer YES to any of the above? YES / NO

Table 3: Required stool donor screening laboratory studies prior to FMT

Stool:

Giardia & Cryptosporidium stool antigen testing Stool ova & parasite testing Cultures for
Salmonella, Shigella and E. coli O157:H7 Clostridium difficile toxin B PCR assay

Blood:

HIV 1&2 Ab/Ag HAV IgM Ab HBV core Ab & Ag HCV Ab HTLV-1 Ab

Table 4: Laboratory studies every 120 days for designated stool donors

Stool:

Giardia & Cryptosporidium stool antigen testing Stool ova & parasite testing Cultures for
Salmonella, Shigella and E. coli O157:H7 Clostridium difficile toxin B PCR assay

Blood:

HIV 1&2 Ab/Ag HAV IgM Ab HBV core Ab & Ag HCV Ab HTLV-1 Ab