Microbial Restoration in Inflammatory Bowel Diseases

Crohn Disease Clinical Trial

— MIRO II  

Official title:

The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04970446
• Other study ID #: StvincentsmelbourneMIROII
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 1, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: November 2023
• Source: St Vincent's Hospital Melbourne
• Contact: Amy Wilson O'Brien
• Phone: 0392311352
• Email: amy.wilson-obrien[@]svha.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Active Crohn's disease

Exclusion Criteria:

• Active perianal or fistulising disease

• Pregnant

• Enteropathy or colitis other than Crohn's disease

• Symptomatic stricture likely to require surgical treatment

• Presence of a stoma

• Presence of an ileoanal pouch

• Immunodeficiency (beyond that caused by immune suppressants used with IBD) e.g. HIV or Common variable immune deficiency

• Prednisolone dose >20mg or budesonide dose >6mg

• Active gastrointestinal infection

• Alcohol consumption of a dependent nature

• Primary sclerosing cholangitis

• Recent overseas travel

• Contact with COVID-19 positive or DHHS-defined close contact of COVID-19 positive individual in 8 weeks prior to study entry

Related Conditions & MeSH terms

• Crohn Disease
• Fecal Microbiota Transplantation
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Microbiome

Intervention

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

Country	Name	City	State
Australia	St Vincents Hospital	Melbourne	Victoria

Sponsors (5)

Lead Sponsor	Collaborator
St Vincent's Hospital Melbourne	BiomeBank Adelaide, Monash University, The Queen Elizabeth Hospital, The University of Queensland

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response	CDAI decrease of =100 or CDAI<150	Week 8