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Microbial Restoration in Inflammatory Bowel Diseases

Study acronym: MIRO II
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 26, 2025 (before its estimated April 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Phase: Phase 2/3 to Phase 1/2v3 Show 5 more changesShow less
    • Start date: Dec 1, 2021 to May 1, 2022
    • Primary completion date: Dec 1, 2024 to Apr 1, 2025
    • Study completion date: Dec 1, 2025 to Apr 1, 2026
    • Eligibility criteria expanded, about 177 words
    • Secondary endpoints expanded, about 29 words
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Dec 1, 2022 to Dec 1, 2024
    • Start date changed from estimate of Aug 1, 2021 to Dec 1, 2021
    • Study sites: 0 to 1
    • Study completion date: Dec 1, 2023 to Dec 1, 2025
    • Study title shortened, about 4 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04970446
Lead Sponsor St Vincent's Hospital Melbourne
Collaborators: The Queen Elizabeth Hospital, BiomeBank Adelaide, The University of Queensland, Monash University
Conditions
(from sponsor)		 Fecal Microbiota Transplantation, Crohn Disease, Inflammatory Bowel Diseases, Microbiome
Related terms Crohn Disease, Inflammatory Bowel Diseases
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov