Observation of Faecal Microbiota Transplantation Use for Restoration of Gut Microbiota in Gastrointestinal Disorders in the Real-World Setting (The REAL-BIOME Study). A Real-World, Prospective, Observational Study.

The study aims to prospectively evaluate the safety and efficacy of faecal microbiota transplantation (FMT) use for restoration of the gut microbiota in gastrointestinal disorders in the real-world setting. Individuals who have been prescribed FMT by their regular specialist physician as part of their clinical care will be eligible to participate in this observational study. This use must have been approved via the TGA-managed Special Access Scheme to be eligible. FMT will not be provided as part of the study. Patients with gastrointestinal disorders including ulcerative colitis, Crohn’s disease, irritable bowel syndrome, immune checkpoint inhibitor-associated enterocolitis, and functional constipation may be followed in this study. Participants will be followed throughout their prescribed treatment with FMT, and will complete surveys that assess FMT safety, efficacy, tolerability/acceptability, and the impact that FMT therapy has on quality of life. Stool samples will be collected from a subset of participants to study microbial factors associated with FMT response and failure in patients with gastrointestinal disorders. Stool will be collected from up to 100 participants enrolled in the ulcerative colitis, Crohn's disease and IBS groups, depending on the number of participants that are enrolled in these groups. Stool may only be collected from participants that live in major cities. Surveys will be completed at baseline (pre-FMT), week 8 post-FMT, and week 52 post-FMT for all participants. Additional surveys may be completed at weeks 28 and/or 40 post-FMT if participants continue on long-term FMT therapy. Participants in the ulcerative colitis, Crohn's disease and immune checkpoint inhibitor-associated enterocolitis groups will be asked to complete adverse event and FMT treatment schedule surveys at week 1 and/or week 4 post-FMT. Surveys will take approximately 5-10 minutes each, to a total of approximately 1 hours in total, however they do not all need to be completed sequentially. All surveys will be electronic and will be completed online. No face-to-face study visits are required. The initial screening, consenting and baseline surveys will be completed via phone or video call.