Microbial Restoration in Inflammatory Bowel Diseases

NCT04970446 | Recruiting Phase 1 DMC

• 1 other identifier: StvincentsmelbourneMIROII
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fecal Microbiota Transplantation; Crohn Disease; Inflammatory Bowel Diseases; Microbiome

Outcome Measures

Primary Outcomes (1)

• Clinical response

  CDAI decrease of ≥100 or CDAI\<150

  Week 8

Secondary Outcomes (12)

• Clinical remission

  Week 8 and week 52 or Week 16 and week 60 (for open FMT group)

• Endoscopic response

  Week 8 and 52 or Week 16 and 60

• Endoscopic remission

  Week 8 and week 52 Week 16 and 60

• Histological Remission

  Week 8 and 52 or Week 16 and 60

• Radiological remission

  Week 8 and 52 or Week 16 and 60

Study Arms (2)

FMT arm

ACTIVE COMPARATOR

Anaerobically prepared, freeze-thawed faecal microbiota transplantation

Drug: Antibiotics; Dietary Supplement: Dietician designed diet; Drug: FMT

Placebo arm

PLACEBO COMPARATOR

Placebo liquid formulation (normal saline, glycerol, food colorant)

Drug: Antibiotics; Dietary Supplement: Dietician designed diet; Other: Placebo

Interventions

Antibiotics DRUG

All patients will receive a one week course of antibiotic therapy.

FMT arm; Placebo arm

Dietician designed diet DIETARY_SUPPLEMENT

All patients will be recommended dietary modification 3 weeks prior to, and during, the study.

FMT arm; Placebo arm

FMT DRUG

Anaerobically prepared stool. Dosing will vary according to mode of administration.

FMT arm

Placebo OTHER

Placebo will contain food colourant, 0.9% normal saline and glycerol.

Placebo arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active Crohn's disease
• Confirmed endoscopic active inflammation (unless isolated small bowel disease that is inaccessible by endoscopy in which case sonographic inflammation is sufficient) within 6 months of study entry AND
• CDAI score of 220-450 AND
• One of the following:
• CRP ≥5mg/L
• faecal calprotectin ≥100μg/g
• inflammation on imaging (either intestinal ultrasound or magnetic resonance imaging)
• Willing and able to attend the study sites for regular endoscopic procedures.

You may not qualify if:

• Active perianal or fistulising disease; Pregnant or intending to become pregnant within 12 months; Enteropathy or colitis other than Crohn's disease; Symptomatic intestinal stricture likely to require surgical treatment; Presence of a stoma; Presence of an ileoanal pouch; Total white cell count less than 3.0 x 109/L; Albumin less than 20g/L; Immunodeficiency (beyond that caused by immune suppressants used for the treatment of IBD) e.g. HIV or Common variable immune deficiency; Anaphylaxis/severe allergy to food; Thiopurine, methotrexate, biologic agent or small molecule inhibitors or aminosalicylates whose dose has been modified within the past two months, 1 month and two weeks of study entry, respectively; Prebiotic, probiotic or antibiotic therapy, or over-the-counter supplements therapy in the two weeks prior to study entry; Rectal topical Crohn's disease therapy in the 2 weeks prior to study entry; Prednisolone dose \>20mg or budesonide dose \>6mg; Unwilling or unable to taper corticosteroids to zero within 8 weeks of initial FMT; Active gastrointestinal infection; Alcohol consumption of a dependent nature; Primary sclerosing cholangitis; Any condition that the treating gastroenterologist deems to pose a theoretical risk to the patient undertaking FMT; Any patient that the treating clinicians feel is incapable of participating in the safe use of FMT.

Sponsors & Collaborators

• St Vincent's Hospital Melbourne: lead
• The Queen Elizabeth Hospital: collaborator
• BiomeBank Adelaide: collaborator
• The University of Queensland: collaborator
• Monash University: collaborator

Study Sites (1)

St Vincents Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Related Publications (1)

• Fehily SR, Wright EK, Basnayake C, Wilson-O'Brien AL, Stanley A, Marks EP, Russell EE, Hamilton AL, Bryant RV, Costello SP, Kamm MA. Faecal microbiota transplantation in Crohn's disease: an Australian randomised placebo-controlled trial protocol. BMJ Open. 2025 Apr 19;15(4):e094714. doi: 10.1136/bmjopen-2024-094714.

  PMID: 40254304 DERIVED

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Michael A Kamm, MD

  St Vincents Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Wilson O'Brien

CONTACT

0392311352; amy.wilson-obrien@svha.org.au

Sasha Fehily, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomisation tables will be computer generated by an independent statistician. The indistinguishable aspect of the FMT syringes (colour, packaging) will ensure the blindness of both patients and physicians in charge.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases

Model Details: Prospective, two clinical center, parallel-arm, randomised, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: July 21, 2021
• Study Start: May 1, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: When data becomes available
• Access Criteria: TBC

Locations

AU (1)