RecruitingPhase 1Phase 2NCT04970446

Microbial Restoration in Inflammatory Bowel Diseases

The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases


Sponsor

St Vincent's Hospital Melbourne

Enrollment

120 participants

Start Date

May 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria8

  • 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 Criteria1

  • 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.

Interventions

DRUGAntibiotics

All patients will receive a one week course of antibiotic therapy.

DIETARY_SUPPLEMENTDietician designed diet

All patients will be recommended dietary modification 3 weeks prior to, and during, the study.

DRUGFMT

Anaerobically prepared stool. Dosing will vary according to mode of administration.

OTHERPlacebo

Placebo will contain food colourant, 0.9% normal saline and glycerol.


Locations(1)

St Vincents Hospital

Melbourne, Victoria, Australia

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NCT04970446


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