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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04970446




Registration number
NCT04970446
Ethics application status
Date submitted
18/07/2021
Date registered
21/07/2021
Date last updated
28/11/2023

Titles & IDs
Public title
Microbial Restoration in Inflammatory Bowel Diseases
Scientific title
The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases
Secondary ID [1] 0 0
StvincentsmelbourneMIROII
Universal Trial Number (UTN)
Trial acronym
MIRO II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fecal Microbiota Transplantation 0 0
Crohn Disease 0 0
Inflammatory Bowel Diseases 0 0
Microbiome 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Antibiotics
Other interventions - Dietician designed diet
Treatment: Drugs - FMT
Other interventions - Placebo

Active Comparator: FMT arm - Anaerobically prepared, freeze-thawed faecal microbiota transplantation

Placebo Comparator: Placebo arm - Placebo liquid formulation (normal saline, glycerol, food colorant)


Treatment: Drugs: Antibiotics
All patients will receive a one week course of antibiotic therapy.

Other interventions: Dietician designed diet
All patients will be recommended dietary modification 3 weeks prior to, and during, the study.

Treatment: Drugs: FMT
Anaerobically prepared stool. Dosing will vary according to mode of administration.

Other interventions: Placebo
Placebo will contain food colourant, 0.9% normal saline and glycerol.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical response
Timepoint [1] 0 0
Week 8

Eligibility
Key inclusion criteria
• Active Crohn's disease
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincents Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Queen Elizabeth Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
BiomeBank Adelaide
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The University of Queensland
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Monash University
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04970446
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael A Kamm, MD
Address 0 0
St Vincents Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amy Wilson O'Brien
Address 0 0
Country 0 0
Phone 0 0
0392311352
Fax 0 0
Email 0 0
amy.wilson-obrien@svha.org.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04970446