Register a trial

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

Please note that the ANZCTR will be unattended from Friday 18th April until Tuesday 22nd April due to the Easter long weekend. Submissions and updates will not be processed during that time.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Secondary outcome [1] 0 0
Clinical remission
Timepoint [1] 0 0
Week 8 and week 52 or Week 16 and week 60 (for open FMT group)
Secondary outcome [2] 0 0
Endoscopic response
Timepoint [2] 0 0
Week 8 and 52 or Week 16 and 60
Secondary outcome [3] 0 0
Endoscopic remission
Timepoint [3] 0 0
Week 8 and week 52 Week 16 and 60
Secondary outcome [4] 0 0
Histological Remission
Timepoint [4] 0 0
Week 8 and 52 or Week 16 and 60
Secondary outcome [5] 0 0
Radiological remission
Timepoint [5] 0 0
Week 8 and 52 or Week 16 and 60
Secondary outcome [6] 0 0
Biochemical response
Timepoint [6] 0 0
Week 8 and 52 or Week 16 and 60
Secondary outcome [7] 0 0
Time to outcomes
Timepoint [7] 0 0
Duration of trial
Secondary outcome [8] 0 0
Maintenance of clinical remission
Timepoint [8] 0 0
Weeks 52 or 60
Secondary outcome [9] 0 0
Sustained clinical remission
Timepoint [9] 0 0
Weeks 52 or 60
Secondary outcome [10] 0 0
Steroid-free clinical remission
Timepoint [10] 0 0
Weeks 52 or 60
Secondary outcome [11] 0 0
Safety outcomes
Timepoint [11] 0 0
Duration of trial
Secondary outcome [12] 0 0
Scientific outcomes
Timepoint [12] 0 0
Week 8 and 52 or Week 16 and 60

Eligibility
Key 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.
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 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.

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 1
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
1/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
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


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