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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Microbial Restoration in Inflammatory Bowel Diseases

The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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; weakened immune system (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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Antibiotics

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

DIETARY_SUPPLEMENT

Dietician designed diet

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

DRUG

FMT

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

OTHER

Placebo

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

Locations (1)

St Vincents Hospital
Melbourne, Victoria, Australia