Fecal Microbiota TransplantationPhase 1/2MIRO IINCT04970446
Microbial Restoration in Inflammatory Bowel Diseases
A Phase 1/2 study testing Antibiotics, Dietician designed diet and FMT in people with Fecal Microbiota Transplantation and Crohn Disease, run by St Vincent's Hospital Melbourne at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fecal Microbiota Transplantation, Crohn Disease, Inflammatory Bowel Diseases
- What is being tested?
- Antibiotics, Dietician designed diet and FMT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteAustralia
- Study dates
- 1 May 2022to 1 Apr 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sasha Fehily, MD contact
Australia1 site, 1 recruiting
- Recruiting
St Vincents Hospital
Melbourne, Victoria, 3004
Sasha Fehily, miro.study@svha.org.au
About this study
Official title: The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases
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.
Read the 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.
- Being tested
- Antibiotics, Dietician designed diet, FMT, Placebo
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
All patients will receive a one week course of antibiotic therapy.
Dietician designed dietDietary supplement
All patients will be recommended dietary modification 3 weeks prior to, and during, the study.
FMTDrug
Anaerobically prepared stool. Dosing will vary according to mode of administration.
PlaceboOther
Placebo will contain food colourant, 0.9% normal saline and glycerol.
| Study group | Role | What they receive |
|---|---|---|
| FMT arm | Active comparator | Anaerobically prepared, freeze-thawed faecal microbiota transplantation Receives: Drug: Antibiotics; Dietary Supplement: Dietician designed diet; Drug: FMT |
| Placebo arm | Placebo comparator | Placebo liquid formulation (normal saline, glycerol, food colorant) Receives: Drug: Antibiotics; Dietary Supplement: Dietician designed diet; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
CDAI decrease of ≥100 or CDAI<150
Measured: Week 8
Secondary outcomes (12)
Clinical remission
CDAI <150
Measured: Week 8 and week 52 or Week 16 and week 60 (for open FMT group)
Endoscopic response
SES-CD reduction by 25% and 50%
Measured: Week 8 and 52 or Week 16 and 60
Endoscopic remission
SES-CD ≤2 or absence of ulcers
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Duration of trial
Maintenance of clinical remission
CDAI <150
Measured: Weeks 52 or 60
Sustained clinical remission
CDAI <150
Measured: Weeks 52 or 60
Steroid-free clinical remission
Steroid-free clinical remission
Measured: Weeks 52 or 60
Safety outcomes
Adverse events
Measured: Duration of trial
Scientific outcomes
Comparison of genetic, microbiological, metabolic and immunologic factors in the responders with the non-responders
Measured: Week 8 and 52 or Week 16 and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 May 2022
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal Microbiota TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, two clinical center, parallel-arm, randomised, double-blind, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- The Queen Elizabeth Hospital, BiomeBank Adelaide, The University of Queensland, Monash University
- Responsible party
- Principal investigator, Michael Kamm, St Vincent's Hospital Melbourne
- Investigators
- Michael A Kamm, MD, Principal investigator, St Vincents Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970446
- Sponsor's protocol ID
- StvincentsmelbourneMIROII
- Acronym
- MIRO II
- Status last verified
- Jan 2025
- First submitted
- 18 Jul 2021
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 40254304
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT04970446
- Acronym / sponsor ID
- MIRO II / StvincentsmelbourneMIROII
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- St Vincent's Hospital MelbourneUniversity, hospital or other
- Collaborators
- The Queen Elizabeth Hospital, BiomeBank Adelaide, The University of Queensland, Monash University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, two clinical center, parallel-arm, randomised, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| FMT arm | Active comparator | Drug: Antibiotics, Dietary Supplement: Dietician designed diet, Drug: FMTAnaerobically prepared, freeze-thawed faecal microbiota transplantation |
| Placebo arm | Placebo comparator | Drug: Antibiotics, Dietary Supplement: Dietician designed diet, Other: PlaceboPlacebo liquid formulation (normal saline, glycerol, food colorant) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Willing and able to attend the study sites for regular endoscopic procedures.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticsAll patients will receive a one week course of antibiotic therapy. | Drug | FMT arm, Placebo arm |
| Dietician designed dietAll patients will be recommended dietary modification 3 weeks prior to, and during, the study. | Dietary supplement | FMT arm, Placebo arm |
| FMTAnaerobically prepared stool. Dosing will vary according to mode of administration. | Drug | FMT arm |
| PlaceboPlacebo will contain food colourant, 0.9% normal saline and glycerol. | Other | Placebo arm |
Primary outcome
Clinical response
Time frame: Week 8
CDAI decrease of ≥100 or CDAI<150
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Derived from this study: PubMed 40254304Fehily 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sasha Fehily, MD contact
Michael A Kamm, MD principal investigator
St Vincents Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Antibiotics, Dietician designed diet and FMT in people with Fecal Microbiota Transplantation and Crohn Disease, run by St Vincent's Hospital Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Wilson O'Brien (0392311352, amy.wilson-obrien@svha.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04970446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.