The efficacy and safety of faecal microbiota transplantation for recurrent or relapsing Clostridium difficile in Western Australia

Affected patients will be screen for CDI by stool toxin PCR and if positive will be offered FMT. They can opt for a related donor or use a frozed sample from an unrelated donor. Donors (related or unrelated) will be screen by a gastroenterologist and an infectious disease consultant. They must be aged 18 to 65 years old, not had any antibiotics for 6 months, viral gastroenteritis for 3 months, travel outside of Australia within the last month, or any past history of gastrointestinal diseases including irritible bowel syndrome and colonic polyps, or if there is a significant family history of bowel cancer then they must have had a colonoscopy within 3 years. There must be no evidence of active infection with hepatitis viruses and other selected blood borne virus plus no history of significant autoimmune disease or severe environmental allergy. Their stool will be screen for CDI as well as a braod spectrum of bacterial, viral or parasitic infections. Unrelated donors will be excluded if there is evidence, physical or biochemical, of metabolic syndrome, cardiovascular disease, depression or serological evidence of HTLV1 or 2. Donors will provide a whole fresh stool in a clean container. the stool will be homogenised by a gastroenterologist in a fumigated cabinet. Each stool sample will be divided into 80-100g alliquots, suspended in normal saline, filtered to remove particulate matter and made up to a volume of 250ml with more normal saline. For fresh related donors the sample is then taken to the endoscopy room where it is delivered into the right colon of the recipient via a colonoscope after the recipient has undergone standard bowel preparation for colonoscopy. For Frozen sample the the filtered faecal microbiota suspension will be centrifuged a 5,000g for 15 minutes and then re-suspended in half the volume of normal saline with 10% sterile pharmaceutical grade glycerol added to aid bacterial survival during freezing. Samples are then stored for upto 104 weeks at -80 degrees C. Thawing of samples occurs over 2 hours in an ice bath prior to FMT as described above. A register of samples will be kept for the purpose of clinical governance and a single sample from each unrelated donnor will be kept for the duration of the study incase of need for retesting. Patients who have contraindications for colonoscopy can be given the FMT via a nasogastric tube. The route of FMT administration will be recorded for each patient. The FMT will be a once only treatment. However if patients fail to respond as judged by clinical improvement and positive stool CDI toxin PCR, a second FMT can be offered after 1 week.. If the patient fails to respond to a second FMT, no further FMT will be offered.