Trials / Recruiting
RecruitingNCT04970446
Microbial Restoration in Inflammatory Bowel Diseases
The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- St Vincent's Hospital Melbourne · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The study will be conducted in two parts. The first part will involve all patients undergoing an optimisation phase, followed by randomisation into either intervention or placebo arms of the induction phase of the study. For patients achieving a pre-determined clinical response threshold at week 8 they will be re-randomised into the maintenance phase of the trial for a further 44 weeks. FMT will be anaerobically prepared, freeze-thawed for administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-05-01
- Primary completion
- 2025-04-01
- Completion
- 2026-04-01
- First posted
- 2021-07-21
- Last updated
- 2025-02-26
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT04970446. Inclusion in this directory is not an endorsement.