Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection
Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection
Interventional, single arm, single-centre trial to evaluate the effectiveness and safety of
 fecal microbiota therapy (FMT) in the investigators population.
This is a study of the effects of FMT for the treatment of patients with recurrent
 Clostridium difficile infection (CDI). The investigators plan to enrol approximately 5-10
 patients per year over the next 5 years to a maximum of 50 patients. Patients with recurrent
 CDI referred to the designated Gastrointestinal (GI) or Infectious Diseases (ID) services
 will be screened for inclusion and exclusion by the primary investigator (PI), sub
 investigators and/or designated study personnel.

 Those patients meeting the criteria will be offered FMT and will be the recipient. An
 informed consent will be obtained from both the recipient and the donor prior to proceeding
 with the study protocol. Demographic information as well as details of the medical history
 and results of standard laboratory tests will be collected on the recipients and donors.

 The donor preferably should be < 60 years old to maximize the fecal microbiota. As this does
 involve biological samples there is a theoretical risk of transmission of an infectious
 agent. To minimize this risk, the donors will be selected preferentially from a spouse or
 sexual partner. If this is not possible, then another relative or acquaintance would serve as
 the donor as identified by the recipient. In either case, the donor will be screened for
 potentially transmissible infections. This will include a health screening questionnaire
 adapted from Canadian Blood Services, a clinical examination and laboratory investigations to
 rule out known transmissible infectious diseases. The donor will complete a satisfaction
 survey.

 The submitted stool will be processed in the lab as per the "Stool Prep Protocol". The route
 of administration will be by retention enema via a rectal tube. As the treatment is not an
 emergency the investigators will have the option, if necessary, to store the stool for future
 treatment. If the sample is not used it will be discarded at 90 days and another sample will
 be obtained if still required.

 Prior to the treatment the recipient will also submit a sample of stool. Along with this a
 portion of the donor sample will be stored in at -80 degrees C for future molecular tests to
 determine the diversity of the microbiota. This may be performed at a later date dependent on
 obtaining the necessary funding.

 Recipients will be followed for 6 months post FMT to monitor for success of treatment,
 adverse reactions, recipient satisfaction and a quality of life assessment.

 note: if laboratory testing for Clostridium difficile (CD) changes the new test will replace
 the cytotoxicity test.
Inclusion Criteria:

 1. Adults aged ≥ 18 yrs of age.

 2. Recurrent CDI despite two courses of standard treatment (ie. 10 days of oral
 vancomycin or metronidazole) and a 6 week taper of oral vancomycin.

 3. Laboratory confirmation of CDI by enzyme immunoassay (EIA), cytotoxicity assay and/or
 polymerase chain reaction (PCR).

 4. Presence of persistent diarrhea defined as ≥ 3 loose or watery bowel movements in 24hr
 continuing for >2 days and diarrhea ongoing at the time of inclusion.

 Exclusion Criteria:

 1. Severely immunosuppressed patients will not be enrolled. This is defined as >20 mg
 prednisone/d for >1 month, recent transplant patients (haematological <2yrs and solid
 organ < 6 months), transplant with active graft versus host disease, HIV (with
 CD4<200), immunosuppressive antibody treatment (eg. tumour necrosis factor inhibitor,
 rituximab), other high dose long term systemic immunosuppression) and severe
 congenital immunodeficiency.

 2. Age <18 years old.

 3. Pregnancy.

 4. Patient expected to expire in < 30d.

 5. Current hospital admission for an indication other than CDI or need for vasopressor
 medication.