The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St Vincent's Hospital Melbourne
• Collaborators: BiomeBank Adelaide; Monash University; The Queen Elizabeth Hospital; The University of Queensland
• Treatments: Anti-Bacterial Agents

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