The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases
Who is this study for? Patients with inflammatory bowel diseases
What treatments are being studied? Antibiotics+Dietician designed diet+FMT
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Drug, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
∙ 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.
Locations
Other Locations
Australia
St Vincents Hospital
RECRUITING
Melbourne
Contact Information
Primary
Amy Wilson O'Brien
amy.wilson-obrien@svha.org.au
0392311352
Backup
Sasha Fehily, MD
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 120
Treatments
Active_comparator: FMT arm
Anaerobically prepared, freeze-thawed faecal microbiota transplantation
Placebo_comparator: Placebo arm
Placebo liquid formulation (normal saline, glycerol, food colorant)
Related Therapeutic Areas
Sponsors
Collaborators: Monash University, The University of Queensland, The Queen Elizabeth Hospital, BiomeBank Adelaide
Leads: St Vincent's Hospital Melbourne