ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000492651p

Ethics application status

Submitted, not yet approved

Date submitted

26/04/2023

Date registered

12/05/2023

Date last updated

8/09/2024

Date data sharing statement initially provided

12/05/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

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.

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

The REAL-BIOME Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Gastrointestinal disorders

Ulcerative colitis

Crohn's disease

Irritable bowel syndrome

Immune checkpoint inhibitor-induced enterocolitis

Functional constipation

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Oral and Gastrointestinal

Crohn's disease

Oral and Gastrointestinal

Inflammatory bowel disease

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

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.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Safety of FMT therapy for gastrointestinal disorders in the real-world setting.

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.

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).

Timepoint [1]

8 weeks post commencement of FMT treatment

Secondary outcome [1]

Clinical response and/or remission following FMT therapy in gastrointestinal disorders based on disorder-specific parameters.
Ulcerative colitis group: Proportion with reduction in Simple Clinical Colitis Activity Index (SCCAI) greater than or equal to 2 points from baseline (clinical response) or SCCAI less than 2 (clinical remission)

Timepoint [1]