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

Plain Language Summary

Simplified for easier understanding

This study is testing whether gut microbiome restoration therapy (a treatment that changes the bacteria living in the gut) can help put active Crohn's disease into remission. **You may be eligible if...** - You have active Crohn's disease confirmed by endoscopy (or bowel ultrasound if the small bowel is hard to reach) within the past 6 months - Your Crohn's disease activity score (CDAI) is between 220 and 450, indicating moderate-to-severe active disease - You also have elevated inflammatory markers (CRP, stool calprotectin, or imaging showing inflammation) - You are willing to attend the study site for regular endoscopic procedures **You may NOT be eligible if...** - You have active fistulas or perianal Crohn's disease - You are pregnant or plan to become pregnant within 12 months - You have a different type of bowel inflammation (not Crohn's) - You have a significant intestinal narrowing (stricture) likely to need surgery - You have a stoma (colostomy or ileostomy) or have had a total colectomy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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