NCT04970446 (MIRO II) is a Phase 1, PHASE2 clinical trial of Antibiotics in Fecal Microbiota Transplantation, sponsored by St Vincent's Hospital Melbourne.

Who is sponsoring NCT04970446?

NCT04970446 is sponsored by St Vincent's Hospital Melbourne.

What drugs are being tested in NCT04970446?

Interventions in NCT04970446: Antibiotics, Dietician designed diet, FMT, Placebo.

What condition does NCT04970446 study?

NCT04970446 studies Fecal Microbiota Transplantation, Crohn Disease, Inflammatory Bowel Diseases, Microbiome.

Is NCT04970446 still recruiting?

NCT04970446 is currently recruiting now. Last updated 26 February 2025.

Last reviewed 2025-02-26 · How we verify

NCT04970446: MIRO II

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Microbial Restoration in Inflammatory Bowel Diseases

Recruiting now Phase 1, PHASE2 Last updated 26 February 2025

What this trial tests

Phase 1, PHASE2 trial testing Antibiotics in Fecal Microbiota Transplantation in 120 participants. Currently enrolling.

Timeline

1 May 2022

Primary endpoint
1 April 2025

1 April 2026

Quick facts

Lead sponsor	St Vincent's Hospital Melbourne
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	1 May 2022
Primary completion	1 April 2025
Estimated completion	1 April 2026
Sites	1 location across Australia

Drugs / interventions tested

Antibiotics — full drug profile →
Dietician designed diet
FMT — full drug profile →
Placebo

Conditions studied

Fecal Microbiota Transplantation — all drugs for Fecal Microbiota Transplantation →
Crohn Disease — all drugs for Crohn Disease →
Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
Microbiome — all drugs for Microbiome →

Sponsor

St Vincent's Hospital Melbourne

Who can join

Adults 18 to 70, any sex, with Fecal Microbiota Transplantation or Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Fecal transplantation for treatment of inflammatory bowel disease.
Imdad A, Pandit NG, Zaman M, Minkoff NZ, et al · · 2023 · cited 51× · PMID 37094824 · DOI 10.1002/14651858.cd012774.pub3
Faecal microbiota transplantation in Crohn's disease: an Australian randomised placebo-controlled trial protocol.
Fehily SR, Wright EK, Basnayake C, Wilson-O'Brien AL, et al · · 2025 · cited 2× · PMID 40254304 · DOI 10.1136/bmjopen-2024-094714

Verify or expand the search:

Other trials of Antibiotics

Trials testing the same drug.

NCT07542314 — Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Participants With Duchenne Muscular Dystrophy Treated in a · Phase 4 · not yet recruiting
NCT06696859 — Patterns of Antibiotics Resistance · not yet recruiting
NCT06377397 — Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates · Phase 3 · not yet recruiting
NCT06483971 — Comparison of Oral Isotretinoin vs Ancomparison of Oral Isotretinoin vs Antibiotics on Corneal Thickness With AV · NA · active not recruiting
NCT05813184 — Prenatal Antibiotics and Breast Milk / Neonatal IgA · recruiting

Other recruiting trials for Fecal Microbiota Transplantation

Currently open trials in the same condition.

NCT06282952 — Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation · NA · recruiting
NCT07149441 — Efficacy and Mechanism of FMT in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study · NA · active not recruiting
NCT06920212 — Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease · NA · active not recruiting
NCT05790356 — Fecal Microbial Transplantation for Rheumatoid Arthritis Trial · NA · recruiting
NCT06782880 — Fecal Microbiota Transplantation for the Prevention of Infectious Complications After Liver Transplantation · NA · recruiting

Other St Vincent's Hospital Melbourne trials

Trials by the same sponsor.

NCT06839248 — Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists · NA · recruiting
NCT05442918 — Expected Normal Ketone Values After Very Low and Bariatric Surgery · completed
NCT03465189 — Validation of a Seizure Monitoring System · completed
NCT03477032 — FMT in Inflammatory Bowel Disease · unknown
NCT03465163 — A Deep Brain Stimulation System in Epilepsy: Tracking Neural Excitability · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04970446 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by St Vincent's Hospital Melbourne
Last refreshed: 26 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04970446.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing