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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
All patients will receive a one week course of antibiotic therapy.
All patients will be recommended dietary modification 3 weeks prior to, and during, the study.
Anaerobically prepared stool. Dosing will vary according to mode of administration.
St Vincents Hospital
Melbourne, Victoria, Australia
RECRUITINGClinical response
CDAI decrease of ≥100 or CDAI\<150
Time frame: Week 8
Clinical remission
CDAI \<150
Time frame: Week 8 and week 52 or Week 16 and week 60 (for open FMT group)
Endoscopic response
SES-CD reduction by 25% and 50%
Time frame: Week 8 and 52 or Week 16 and 60
Endoscopic remission
SES-CD ≤2 or absence of ulcers
Time frame: Week 8 and week 52 Week 16 and 60
Histological Remission
The absence of ulcers; the absence of acute inflammation histologically; one of either Geboes Score or Robarts Histology Index
Time frame: Week 8 and 52 or Week 16 and 60
Radiological remission
IUS (BWT \<3mm and/or Limberg 0 or 1) or MRI (Wall thickness \<4mm and no or minimal wall enhancement)
Time frame: Week 8 and 52 or Week 16 and 60
Biochemical response
Normalisation of CRP and faecal calprotectin (\<50ug/g, \<100ug/g, \<150ug/g, \<200ug/g, \<250ug/g
Time frame: Week 8 and 52 or Week 16 and 60
Time to outcomes
Time taken to achieve clinical response or remission during induction and maintenance phases
Time frame: Duration of trial
Sasha Fehily, MD
CONTACT
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Placebo will contain food colourant, 0.9% normal saline and glycerol.
Maintenance of clinical remission
CDAI \<150
Time frame: Weeks 52 or 60
Sustained clinical remission
CDAI \<150
Time frame: Weeks 52 or 60
Steroid-free clinical remission
Steroid-free clinical remission
Time frame: Weeks 52 or 60
Safety outcomes
Adverse events
Time frame: Duration of trial
Scientific outcomes
Comparison of genetic, microbiological, metabolic and immunologic factors in the responders with the non-responders
Time frame: Week 8 and 52 or Week 16 and 60