Clinical trial NCT04970446: Microbial Restoration in Inflammatory Bowel Diseases
Official title: The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Fecal Microbiota Transplantation
Crohn Disease
Inflammatory Bowel Diseases
Microbiome
Lead sponsor: St Vincent's Hospital Melbourne
Sponsor class: OTHER
Collaborators: name: The Queen Elizabeth Hospital
name: BiomeBank Adelaide
name: The University of Queensland
name: Monash University
First posted: 2021-07-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, two clinical center, parallel-arm, randomised, double-blind, placebo-controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Clinical response
timeFrame: Week 8
Secondary outcomes:
measure: Clinical remission
timeFrame: Week 8 and week 52 or Week 16 and week 60 (for open FMT group)
measure: Endoscopic response
timeFrame: Week 8 and 52 or Week 16 and 60
measure: Endoscopic remission
timeFrame: Week 8 and week 52 Week 16 and 60
measure: Histological Remission
timeFrame: Week 8 and 52 or Week 16 and 60
measure: Radiological remission
timeFrame: Week 8 and 52 or Week 16 and 60
measure: Biochemical response
timeFrame: Week 8 and 52 or Week 16 and 60
measure: Time to outcomes
timeFrame: Duration of trial
measure: Maintenance of clinical remission
timeFrame: Weeks 52 or 60
measure: Sustained clinical remission
timeFrame: Weeks 52 or 60
measure: Steroid-free clinical remission
timeFrame: Weeks 52 or 60
measure: Safety outcomes
timeFrame: Duration of trial
measure: Scientific outcomes
timeFrame: Week 8 and 52 or Week 16 and 60
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: St Vincents Hospital
state: Victoria
Study officials:
affiliation: St Vincents Hospital
name: Michael A Kamm, MD
role: PRINCIPAL_INVESTIGATOR
References: