Restoring gut bacteria in patients with Crohn's disease

The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases

This study is testing whether a treatment using healthy gut bacteria can help people with active Crohn's disease feel better.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: St Vincent's Hospital Melbourne (other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT04970446 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of fecal microbiota transplantation (FMT) on patients with active Crohn's disease through a double-blind, placebo-controlled design. The study consists of an optimization phase followed by randomization into intervention or placebo groups, with a focus on achieving clinical response thresholds. Patients who respond positively at week 8 will enter a maintenance phase lasting an additional 44 weeks. The FMT will be prepared anaerobically and administered after being freeze-thawed.

Who should consider this trial

Good fit: Ideal candidates are adults with active Crohn's disease who meet specific clinical and inflammatory criteria.

Not a fit: Patients with active perianal disease, fistulizing disease, or other forms of colitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the management of Crohn's disease by restoring healthy gut microbiota.

How similar studies have performed: Previous studies have shown promising results with fecal microbiota transplantation in similar conditions, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Active perianal or fistulising disease; Pregnant or intending to become pregnant within 12 months; Enteropathy or colitis other than Crohn's disease; Symptomatic intestinal stricture likely to require surgical treatment; Presence of a stoma; Presence of an ileoanal pouch; Total white cell count less than 3.0 x 109/L; Albumin less than 20g/L; Immunodeficiency (beyond that caused by immune suppressants used for the treatment of IBD) e.g. HIV or Common variable immune deficiency; Anaphylaxis/severe allergy to food; Thiopurine, methotrexate, biologic agent or small molecule inhibitors or aminosalicylates whose dose has been modified within the past two months, 1 month and two weeks of study entry, respectively; Prebiotic, probiotic or antibiotic therapy, or over-the-counter supplements therapy in the two weeks prior to study entry; Rectal topical Crohn's disease therapy in the 2 weeks prior to study entry; Prednisolone dose \>20mg or budesonide dose \>6mg; Unwilling or unable to taper corticosteroids to zero within 8 weeks of initial FMT; Active gastrointestinal infection; Alcohol consumption of a dependent nature; Primary sclerosing cholangitis; Any condition that the treating gastroenterologist deems to pose a theoretical risk to the patient undertaking FMT; Any patient that the treating clinicians feel is incapable of participating in the safe use of FMT.

Where this trial is running

Melbourne, Victoria

• St Vincents Hospital — Melbourne, Victoria, Australia (RECRUITING)

Study contacts

• Principal investigator: Michael A Kamm, MD — St Vincents Hospital
• Study coordinator: Amy Wilson O'Brien

Conditions: Fecal Microbiota Transplantation, Crohn Disease, Inflammatory Bowel Diseases, Microbiome