search
Back to results

The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases (MIRO II)

Primary Purpose

Fecal Microbiota Transplantation, Crohn Disease, Inflammatory Bowel Diseases

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Antibiotics
Dietician designed diet
FMT
Placebo
Sponsored by
St Vincent's Hospital Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Microbiota Transplantation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Active Crohn's disease

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    FMT arm

    Placebo arm

    Arm Description

    Anaerobically prepared, freeze-thawed faecal microbiota transplantation

    Placebo liquid formulation (normal saline, glycerol, food colorant)

    Outcomes

    Primary Outcome Measures

    Clinical response
    CDAI decrease of ≥100 or CDAI<150

    Secondary Outcome Measures

    Full Information

    First Posted
    July 18, 2021
    Last Updated
    July 18, 2021
    Sponsor
    St Vincent's Hospital Melbourne
    Collaborators
    The Queen Elizabeth Hospital, BiomeBank Adelaide, The University of Queensland, Monash University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04970446
    Brief Title
    The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases
    Acronym
    MIRO II
    Official Title
    The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2021 (Anticipated)
    Primary Completion Date
    December 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St Vincent's Hospital Melbourne
    Collaborators
    The Queen Elizabeth Hospital, BiomeBank Adelaide, The University of Queensland, Monash University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fecal Microbiota Transplantation, Crohn Disease, Inflammatory Bowel Diseases, Microbiome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, two clinical center, parallel-arm, randomised, double-blind, placebo-controlled trial
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Randomisation tables will be computer generated by an independent statistician. The indistinguishable aspect of the FMT syringes (colour, packaging) will ensure the blindness of both patients and physicians in charge.
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FMT arm
    Arm Type
    Active Comparator
    Arm Description
    Anaerobically prepared, freeze-thawed faecal microbiota transplantation
    Arm Title
    Placebo arm
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo liquid formulation (normal saline, glycerol, food colorant)
    Intervention Type
    Drug
    Intervention Name(s)
    Antibiotics
    Intervention Description
    All patients will receive a one week course of antibiotic therapy.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Dietician designed diet
    Intervention Description
    All patients will be recommended dietary modification 3 weeks prior to, and during, the study.
    Intervention Type
    Drug
    Intervention Name(s)
    FMT
    Intervention Description
    Anaerobically prepared stool. Dosing will vary according to mode of administration.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo will contain food colourant, 0.9% normal saline and glycerol.
    Primary Outcome Measure Information:
    Title
    Clinical response
    Description
    CDAI decrease of ≥100 or CDAI<150
    Time Frame
    Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • Active Crohn's disease 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amy Wilson O'Brien
    Phone
    +61430461146
    Email
    amy.wilson-obrien@svha.org.au
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sasha Fehily, MD
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael A Kamm, MD
    Organizational Affiliation
    St Vincents Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Time Frame
    When data becomes available
    IPD Sharing Access Criteria
    TBC

    Learn more about this trial

    The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases

    We'll reach out to this number within 24 hrs