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RECRUITING
NCT04970446
PHASE1/PHASE2

Microbial Restoration in Inflammatory Bowel Diseases

Sponsor: St Vincent's Hospital Melbourne

View on ClinicalTrials.gov

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.

Official title: The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2022-05-01

Completion Date

2026-04-01

Last Updated

2025-02-26

Healthy Volunteers

No

Interventions

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