Microbial Restoration in Inflammatory Bowel Diseases

Phase 2

Recruiting

• Conditions: Fecal Microbiota Transplantation; Microbiome; Inflammatory Bowel Diseases; Crohn Disease
• Interventions: Drug: Antibiotics; Dietary Supplement: Dietician designed diet; Drug: FMT; Other: Placebo

• Registration Number: NCT04970446
• Lead Sponsor: St Vincent's Hospital Melbourne

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-07-18
• Study First Submitted QC: 2021-07-18
• Study First Posted: 2021-07-21
• Study Start: 2021-12-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Active Crohn's disease

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMT arm	Dietician designed diet	Anaerobically prepared, freeze-thawed faecal microbiota transplantation
FMT arm	FMT	Anaerobically prepared, freeze-thawed faecal microbiota transplantation
Placebo arm	Antibiotics	Placebo liquid formulation (normal saline, glycerol, food colorant)
Placebo arm	Dietician designed diet	Placebo liquid formulation (normal saline, glycerol, food colorant)
Placebo arm	Placebo	Placebo liquid formulation (normal saline, glycerol, food colorant)
FMT arm	Antibiotics	Anaerobically prepared, freeze-thawed faecal microbiota transplantation

Primary Outcome Measures

Name	Time	Method
Clinical response	Week 8	CDAI decrease of ≥100 or CDAI\<150

Trial Locations

Locations (1)

St Vincents Hospital; 🇦🇺 Melbourne, Victoria, Australia