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Faecal microbiota transplantation in Crohn's disease: an Australian randomised placebo-controlled trial protocol
Sasha R Fehily1,2, Emily K Wright1,2, Chamara Basnayake1,2
1Department of Gastroenterology, St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia.
Introduction:
The enteric microbiota drives inflammation in Crohn's disease. Yet, there are no placebo controlled trials evaluating the efficacy and safety of faecal microbiota transplantation (FMT) in inducing and maintaining remission in patients with active Crohn's disease. The Microbial Restoration (MIRO) study aims to establish this evidence.
Methods And Analysis:
At two specialist inflammatory bowel disease centres, 120 enrolled patients will have a 3-week period of diet optimisation (removal of ultra-processed foods) together with a 7-day course of antibiotics (to facilitate subsequent FMT engraftment). Patients will then be stratified to upper gut (for disease proximal to the splenic flexure) or lower gut (distal to the splenic flexure) disease. Patients will then be randomised in a 2:1 ratio to receive anaerobically prepared stool or placebo for 8 weeks either by gastroscopy, or colonoscopy and enemas. Clinical response at 8 weeks (Crohn's Disease Activity Index (CDAI) reduction ≥100 points or to <150 points) is the primary outcome measure. Non-responders to placebo and partial responders to FMT (CDAI decrease <100 but >70) receive FMT for weeks 8-16.Patients achieving clinical response from FMT after 8 or 16 weeks will be randomised in a 1:1 ratio to either a 44-week maintenance phase of FMT or placebo. Patients will receive FMT from one donor throughout the study.The MIRO study will establish whether FMT is an effective and safe therapy to induce and maintain remission in patients with active Crohn's disease.
Ethics And Dissemination:
Ethical approval has been received by the St Vincent's Hospital Melbourne Human Research Ethics Committee (HREC-A 084/21). The results will be disseminated in peer-reviewed journals and presented at international conferences.
Trial Registration Number:
ClinicalTrials.gov: NCT04970446; Registered on 20 July 2021.
Insights
Faecal microbiota transplantation (FMT) is being studied for Crohn's disease. The MIRO study investigates if FMT can effectively induce and maintain remission in patients with active Crohn's disease.
Area of Science:
- Gastroenterology
- Microbiology
- Clinical Trials
Background:
- The enteric microbiota plays a key role in driving inflammation in Crohn's disease.
- Currently, there is a lack of placebo-controlled trials assessing the efficacy and safety of fecal microbiota transplantation (FMT) for inducing and maintaining remission in active Crohn's disease.
Purpose of the Study:
- To evaluate the efficacy and safety of FMT in inducing and maintaining remission in patients with active Crohn's disease.
- To establish evidence for FMT as a therapeutic option in Crohn's disease management.
Main Methods:
- A 3-week diet optimization and 7-day antibiotic course precedes randomization.
- Patients are randomized (2:1) to receive FMT or placebo for 8 weeks via upper or lower gut administration.
- Primary outcome is clinical response at 8 weeks, with subsequent phases for non-responders and maintenance therapy.
Main Results:
- Primary outcome measure is clinical response at 8 weeks, defined by a reduction in the Crohn's Disease Activity Index (CDAI).
- Further treatment phases are designed for non-responders and to assess maintenance of remission.
- The study will provide data on the effectiveness and safety of FMT in Crohn's disease.
Conclusions:
- The Microbial Restoration (MIRO) study aims to determine if FMT is an effective and safe therapy for Crohn's disease.
- Results will inform clinical practice regarding the use of FMT for inducing and maintaining remission.
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