The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04970446
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	St Vincent's Hospital Melbourne
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Michael A Kamm, MD
Principal Investigator Affiliation	St Vincents Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fecal Microbiota Transplantation, Crohn Disease, Inflammatory Bowel Diseases, Microbiome

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: FMT arm

Anaerobically prepared, freeze-thawed faecal microbiota transplantation

Placebo Comparator: Placebo arm

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

Interventions

Drug: - Antibiotics

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

Dietary Supplement: - Dietician designed diet

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

Drug: - FMT

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

Other: - Placebo

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Amy Wilson O'Brien

amy.wilson-obrien@svha.org.au

+61430461146

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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