Microbial Restoration in Inflammatory Bowel Diseases

Study Overview
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Brief Summary
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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
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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.

Official Title
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The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases

Conditions
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Fecal Microbiota Transplantation, Crohn Disease, Inflammatory Bowel Diseases, Microbiome

Intervention / Treatment
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* Drug: Antibiotics
* Dietary Supplement: Dietician designed diet
* Drug: FMT
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, two clinical center, parallel-arm, randomised, double-blind, placebo-controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FMT arm<br>Anaerobically prepared, freeze-thawed faecal microbiota transplantation | Drug: Antibiotics<br>* All patients will receive a one week course of antibiotic therapy.<br>Dietary Supplement: Dietician designed diet<br>* All patients will be recommended dietary modification 3 weeks prior to, and during, the study.<br>Drug: FMT<br>* Anaerobically prepared stool. Dosing will vary according to mode of administration.<br>|
| Placebo Comparator: Placebo arm<br>Placebo liquid formulation (normal saline, glycerol, food colorant) | Drug: Antibiotics<br>* All patients will receive a one week course of antibiotic therapy.<br>Dietary Supplement: Dietician designed diet<br>* All patients will be recommended dietary modification 3 weeks prior to, and during, the study.<br>Other: Placebo<br>* Placebo will contain food colourant, 0.9% normal saline and glycerol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | CDAI decrease of ≥100 or CDAI<150 | Week 8 |