Overview
This is a prospective, two-centre, double-blind, parallel-arm, randomised, placebo-controlled trial evaluating the impact of FMT on patients with active Crohn's disease.
Description
The study will be conducted in two parts. The first part will involve all patients undergoing an optimisation phase, followed by randomisation into either intervention or placebo arms of the induction phase of the study. For patients achieving a pre-determined clinical response threshold at week 8 they will be re-randomised into the maintenance phase of the trial for a further 44 weeks.
FMT will be anaerobically prepared, freeze-thawed for administration.
Eligibility
Inclusion Criteria:
• Active Crohn's disease
Exclusion Criteria:
- Active perianal or fistulising disease
- Pregnant
- Enteropathy or colitis other than Crohn's disease
- Symptomatic stricture likely to require surgical treatment
- Presence of a stoma
- Presence of an ileoanal pouch
- Immunodeficiency (beyond that caused by immune suppressants used with IBD) e.g. HIV or Common variable immune deficiency
- Prednisolone dose >20mg or budesonide dose >6mg
- Active gastrointestinal infection
- Alcohol consumption of a dependent nature
- Primary sclerosing cholangitis
- Recent overseas travel
- Contact with COVID-19 positive or DHHS-defined close contact of COVID-19 positive individual in 8 weeks prior to study entry