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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04970446
Ethics application status
Date submitted
18/07/2021
Date registered
21/07/2021

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
Treatment: Other - 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.

Treatment: Other: 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
Treatment: Other
Intervention code [3] 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
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
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?


Supporting document/s available: Statistical analysis plan (SAP)
When will data be available (start and end dates)?
When data becomes available
Available to whom?
TBC
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04970446