Microbial Restoration in Inflammatory Bowel Diseases
Phase 1 / Phase 2 · Testing Antibiotics, Dietician designed diet and FMT · 1 site · St Vincent's Hospital Melbourne
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Antibiotics (a drug), Dietician designed diet (a dietary supplement) and FMT (a drug) as a possible treatment. Condition(s) listed: Fecal Microbiota Transplantation, Crohn Disease and Inflammatory Bowel Diseases.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 5 more requirement(s). There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 120 participants are expected to take part.
- Start date: 2022-05-01.
- Main results expected around 2025-04-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Australia.
Main thing being measured
- Clinical response (Week 8)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional |
| Conditions | Fecal Microbiota Transplantation; Crohn Disease; Inflammatory Bowel Diseases; Microbiome |
| Lead sponsor | St Vincent's Hospital Melbourne |
| Collaborators | The Queen Elizabeth Hospital; BiomeBank Adelaide; The University of Queensland; Monash University |
| Enrollment | 120 (estimated) |
| Start date | 2022-05-01 |
| Primary completion (est.) | 2025-04-01 |
| First posted | 2021-07-21 |
| Last updated | 2025-02-26 |
| Official title | The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases |
| ClinicalTrials.gov ID | NCT04970446 |
Interventions
- Antibiotics (Drug)
All patients will receive a one week course of antibiotic therapy. - Dietician designed diet (Dietary Supplement)
All patients will be recommended dietary modification 3 weeks prior to, and during, the study. - FMT (Drug)
Anaerobically prepared stool. Dosing will vary according to mode of administration. - Placebo (Other)
Placebo will contain food colourant, 0.9% normal saline and glycerol.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| St Vincents Hospital | Melbourne, Victoria | Australia | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.