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.

Not Applicable

Conditions: Gastrointestinal disorders
Ulcerative colitis
Crohn's disease
Irritable bowel syndrome
Immune checkpoint inhibitor-induced enterocolitis
Oral and Gastrointestinal - Crohn's disease
Oral and Gastrointestinal - Inflammatory bowel disease
Functional constipation
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Registration Number: ACTRN12623000492651

Lead Sponsor: BiomeBank

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

1) Aged 18 years or older.
2) Confirmed diagnosis of ulcerative colitis, Crohn's disease, irritable bowel syndrome, immune checkpoint inhibitor-induced enterocolitis, or functional constipation.
3) Prescribed BiomeBank FMT by treating specialist physician for their gastrointestinal disorder. The prescribing physician must have received approval from the TGA to treat the patient with FMT off-label via the Special Access Scheme. This must occur before patient is eligible for the study, but is not a part of the study process.
4) Has not received FMT in 8 weeks prior to study entry.

Exclusion Criteria

1) Anaphylactic food allergy.
2) Pregnancy.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of FMT therapy for gastrointestinal disorders in the real-world setting. <br><br>Assessed using a formal adverse event / safety questionnaire developed for this study, and aligned with the Common Terminology Criteria for Adverse Events (CTCAE). Symptoms will be defined by the Medical Dictionary for Regulatory Activities (MedDRA) code. <br><br>Participants will continue to be followed by their FMT prescribing physician who will manage adverse events in line with standard of care. Expected adverse events to FMT use are generally gastrointestinal and transient in nature (for e.g. diarrhoea, stomach ache, bloating).[ 8 weeks post commencement of FMT treatment]

Secondary Outcome Measures