Fecal Microbiota Transplant
Fecal Microbiota Transplant
The study will provide data to show the effectiveness of Fecal Microbiota Transplant in
 patients with recurrent Clostridium difficile infection.

 Fecal Microbiota Transplant (FMT) is a procedure in which healthy colon contents of a
 carefully screened donor is inserted into the colon of a compromised patient. FMT is a
 procedure to replace beneficial bacteria that has been killed or suppressed, most commonly by
 use of antibiotics. Currently it is utilized as an experimental treatment for Clostridium
 difficile infection (CDI). This procedure is predicted to reduce the cost both financially
 and physically for the CDI patient and facility.
Methodist Health System wishes to offer transplant services to our CDI populations which meet
 all criteria for recurrent intractable disease. The objective is to reduce the cost both
 financially and physically to patients and the facility, of living with chronic or recurrent
 CDI disease. This study is to provide treatment and demonstrate documented outcomes and
 success rates in a manner that protects both the patients and the facility. Of note this
 treatment is currently being provided by many facilities in Texas, under the FDA
 Investigational New Drug (IND) enforcement discretion.

 The study will provide data to show the effectiveness of Fecal Microbiota Transplant in
 patients with recurrent Clostridium difficile infection. This study will only examine FMT as
 it is the only available therapy beyond antibiotic treatment. When patients are considered
 for FMT they have already failed traditional therapeutic medications.

 Patients will be required to meet a specified criteria set forth for chronic or severe CDI
 infection. Chronic infection is defined as the third or greater episode of C Difficile
 infection, proven by a positive stool assay with previous documented treatments. Patients
 must be first treated with first line drug therapies which include vancomycin, metronidazole
 or fidaxomicin without cure. They must have been treated with at least one course of drugs
 over a six to eight week period of a vancomycin taper or vancomycin treatment followed by
 rifaximin for two weeks. Severe CDI infection is defined as refractory moderate to severe CDI
 diarrhea, with failing vancomycin drug therapy.

 Patients with contraindicated co-morbidities will be excluded. Comorbidities include severe
 bowel disease which would preclude colonoscopy, severe underlying immune suppression or
 decompensated liver cirrhosis.

 Patients will be under the care of a physician who is an identified investigator
 (sub-investigator) of this study for preparation, procedure and follow up care. Patients will
 be counseled by this physician regarding the risks and side effects of the procedure and
 transplant. Staff will only reinforce details from written materials given to patients.
 Questions outside of the written materials will be directed to the investigators for follow
 up.

 Risks include, but are not limited to the following.

 -  Transplant making no improvement in the course of their CDI.

 -  Common side effects including transient gas, bloating and rectal irritation

 -  Surgical risks which can include blood clots, excessive bleeding, allergic reactions and
 death. More common surgical risks are infection, drug reactions, bleeding, and
 perforation.

 -  Transmission of antibiotic-resistant bacteria: These are resistant to one or more
 antibiotics. These bacteria could be transmitted through FMT and cause a serious
 infection. The FMT that you will receive is provided by a company called OpenBiome,
 where donors who provide stool for the FMT treatments undergo screening for certain
 antibiotic-resistant bacteria and clinical risk factors that would make their exposure
 to antibiotic resistant bacteria more likely. Individuals who test positive for these
 bacteria or have these risk factors are excluded from donating.

 Patients will sign three informed consents. The first consent is to acknowledge the basis of
 the treatment is part of a research study (exhibit 1). The second consent) specifies that FMT
 is experimental in nature, and reviews the potential risks and benefits of the transplant.
 The third is the Methodist Health System "Disclosure and Consent" that is used for
 colonoscopy procedures.
Inclusion Criteria:

 -  Recurring CDI after three episodes of mild to moderate C Diff infections and failure
 to respond to appropriate antimicrobial treatment of six to eight weeks.

 -  Metronidazole

 -  Vancomycin

 -  At least two episodes of severe C diff infection that have required hospitalization
 and significant morbidity within one year

 -  Severe C Diff infection requiring hospitalization and non- responsive to maximal
 medication therapy

 Exclusion Criteria:

 -  advanced Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome
 (AIDS)

 -  cirrhosis of the liver

 -  recent bone marrow transplants

 -  medication suppressed immune systems (allowed per physician discretion if benefit
 outweighs risk)

 -  pregnancy

 -  Toxic megacolon or ileus present