Microbial Restoration in Inflammatory Bowel Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Antibiotics, Dietician designed diet, FMT, Placebo.
- Who it may be relevant to
- Registry conditions: Fecal Microbiota Transplantation, Crohn Disease, Inflammatory Bowel Diseases, Microbiome. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases
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.
Detailed 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.
Interventions
- Drug Antibiotics
All patients will receive a one week course of antibiotic therapy. - Dietary supplement Dietician designed diet
All patients will be recommended dietary modification 3 weeks prior to, and during, the study. - Drug FMT
Anaerobically prepared stool. Dosing will vary according to mode of administration. - Other Placebo
Placebo will contain food colourant, 0.9% normal saline and glycerol.
Primary outcome measures
- Clinical response [Time frame: Week 8]
Secondary outcome measures (12)
- Clinical remission [Time frame: Week 8 and week 52 or Week 16 and week 60 (for open FMT group)]
- Endoscopic response [Time frame: Week 8 and 52 or Week 16 and 60]
- Endoscopic remission [Time frame: Week 8 and week 52 Week 16 and 60]
- Histological Remission [Time frame: Week 8 and 52 or Week 16 and 60]
- Radiological remission [Time frame: Week 8 and 52 or Week 16 and 60]
- Biochemical response [Time frame: Week 8 and 52 or Week 16 and 60]
- Time to outcomes [Time frame: Duration of trial]
- Maintenance of clinical remission [Time frame: Weeks 52 or 60]
- Sustained clinical remission [Time frame: Weeks 52 or 60]
- Steroid-free clinical remission [Time frame: Weeks 52 or 60]
- Safety outcomes [Time frame: Duration of trial]
- Scientific outcomes [Time frame: Week 8 and 52 or Week 16 and 60]
Eligibility criteria
Inclusion criteria
Active Crohn's disease
- Confirmed endoscopic active inflammation (unless isolated small bowel disease that is inaccessible by endoscopy in which case sonographic inflammation is sufficient) within 6 months of study entry AND
- CDAI score of 220-450 AND
- One of the following:
- CRP ≥5mg/L
- faecal calprotectin ≥100μg/g
- inflammation on imaging (either intestinal ultrasound or magnetic resonance imaging)
- Willing and able to attend the study sites for regular endoscopic procedures.
Exclusion criteria
Active perianal or fistulising disease; Pregnant or intending to become pregnant within 12 months; Enteropathy or colitis other than Crohn's disease; Symptomatic intestinal stricture likely to require surgical treatment; Presence of a stoma; Presence of an ileoanal pouch; Total white cell count less than 3.0 x 109/L; Albumin less than 20g/L; Immunodeficiency (beyond that caused by immune suppressants used for the treatment of IBD) e.g. HIV or Common variable immune deficiency; Anaphylaxis/severe allergy to food; Thiopurine, methotrexate, biologic agent or small molecule inhibitors or aminosalicylates whose dose has been modified within the past two months, 1 month and two weeks of study entry, respectively; Prebiotic, probiotic or antibiotic therapy, or over-the-counter supplements therapy in the two weeks prior to study entry; Rectal topical Crohn's disease therapy in the 2 weeks prior to study entry; Prednisolone dose >20mg or budesonide dose >6mg; Unwilling or unable to taper corticosteroids to zero within 8 weeks of initial FMT; Active gastrointestinal infection; Alcohol consumption of a dependent nature; Primary sclerosing cholangitis; Any condition that the treating gastroenterologist deems to pose a theoretical risk to the patient undertaking FMT; Any patient that the treating clinicians feel is incapable of participating in the safe use of FMT.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- St Vincents Hospital — Melbourne
Publications
- Fehily SR, Wright EK, Basnayake C, Wilson-O'Brien AL, Stanley A, Marks EP, Russell EE, Hamilton AL, Bryant RV, Costello SP, Kamm MA. Faecal microbiota transplantation in Crohn's disease: an Australian randomised placebo-controlled trial protocol. BMJ Open. 2025 Apr 19;15(4):e094714. doi: 10.1136/bmjopen-2024-094714. PMID 40254304
Identifiers
NCT: NCT04970446 · StvincentsmelbourneMIROII