Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT for Recurrent CDI

Patient inclusion criteria

• Age 18 years or older.
• Able to provide informed consent.
• Laboratory or pathology: confirmed diagnosis of recurrent CDI with symptoms (defined below) within the previous 180 days.
• ≥ 2 episodes of CDI within 6 months and/or ongoing symptoms consistent with CDI despite treatment with oral vancomycin at a dose of at least 125 mg 4 times daily for at least 5 days.

Symptoms of CDI, diarrhea defined as: 3 or more unformed bowel movements in 24 hours for a minimum of 2 days with no other causes for diarrhea. Subjects will be required to have laboratory or pathology-confirmed diagnosis of recurrent C. difficile infection where recurrence is defined as return of diarrhea and positive stool test after a period of symptom resolution within 8 weeks of the first episode and has received at least a 10-day course of standard antibiotic therapy.

Patient exclusion criteria

• Planned or actively participating in another clinical trial.
• Patients with neutropenia with absolute neutrophil count <0.5 x 109/L
• Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
• Peripheral white blood cell count > 30.0 x 10E9/L AND temperature > 38.0 oC
• Active gastroenteritis due to Salmonella, Shigella, E. coli 0157H7, Yersinia or Campylobacter.
• Presence of colostomy
• Unable to tolerate HBT or enema for any reason.
• Requiring systemic antibiotic therapy for more than 7 days.
• Actively taking Saccharomyces boulardii
• Severe underlying disease such that the patient is not expected to survive for at least 30 days.
• Any condition that, in the opinion of the investigator, that the treatment may pose a health risk to the subject.

Donor inclusion

• Able to provide and sign informed consent.
• Able to complete and sign the donor questionnaire
• Able to adhere to fecal transplantation stool collection standard operating procedure.

Donor exclusion

• Tested positive for any of the following: Human Immunodeficiency virus (HIV) 1/2, hepatitis IgM, hepatitis B (HBsAg), hepatitis C antibody, syphilis, human T- lymphotrophic virus (HTLV) 1/II and vancomycin resistant Enterococcus (VRE), methicillin resistant S. aureus (MRSA), Salmonella, Shigella, E.coli O157 H7, Yersinia and Campylobacter.
• Detection of ova, parasites, C. difficile toxin, norovirus, adenovirus, rotavirus on stool examination
• History of any type of active cancer or autoimmune disease
• History of risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, prion or any neurological disease as determined by the donor questionnaire, appendix B.
• History of gastrointestinal comorbidities, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation or diarrhea
• Receipt of blood transfusion from a country other than Canada in preceding 6 months
• Antibiotic use or any systemic immunosuppressive agents in the 3 months prior to stool donation
• Receipt of any type of live vaccine within 3 months prior to stool donation
• Ingestion of nut or shell fish 3 days preceding donation if the recipient has known allergies to these food.
• Any current or previous medical or psychosocial condition or behaviours which in the opinion of the investigator may pose risk to the recipients or the donor