Clinical trial

The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases

Name

StvincentsmelbourneMIROII

Description

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 arms

Trial start

2021-12-01

Estimated PCD

2024-12-01

Trial end

2025-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Antibiotics

All patients will receive a one week course of antibiotic therapy.

Arms:

FMT arm, Placebo arm

Dietician designed diet

All patients will be recommended dietary modification 3 weeks prior to, and during, the study.

Arms:

FMT arm, Placebo arm

FMT

Anaerobically prepared stool. Dosing will vary according to mode of administration.

Arms:

FMT arm

Placebo

Placebo will contain food colourant, 0.9% normal saline and glycerol.

Arms:

Placebo arm

Size

120

Primary endpoint

Clinical response

Week 8

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, two clinical center, parallel-arm, randomised, double-blind, placebo-controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

Updated at

2023-11-28

1 organization

1 product

1 drug

4 indications

Organization

St Vincent's Hospital Melbourne

Product

Antibiotics

Indication

FMT