Microbial Restoration in Inflammatory Bowel Diseases (MIRO II)

St Vincent's Hospital Melbourne

Status and phase: Enrolling; Phase 2; Phase 1

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

Treatments: Dietary Supplement: Dietician designed diet; Drug: FMT; Other: Placebo; Drug: Antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT04970446

StvincentsmelbourneMIROII

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

FMT arm

Active Comparator group

Description:

Anaerobically prepared, freeze-thawed faecal microbiota transplantation

Treatment:

Drug: Antibiotics

Drug: FMT

Dietary Supplement: Dietician designed diet

Placebo arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Antibiotics

Other: Placebo

Dietary Supplement: Dietician designed diet