Actively Recruiting
Microbial Restoration in Inflammatory Bowel Diseases
Led by St Vincent's Hospital Melbourne · Updated on 2025-02-26
120
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
S
St Vincent's Hospital Melbourne
Lead Sponsor
T
The Queen Elizabeth Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Microbial Restoration in Inflammatory Bowel Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active Crohn's disease
- Confirmed endoscopic active inflammation within 6 months or sonographic inflammation if small bowel inaccessible
- Crohn's Disease Activity Index score between 220 and 450
- At least one of the following: CRP 65 mg/L, faecal calprotectin 100 bcg/g, or inflammation on imaging
- Willing and able to attend regular endoscopic procedures at study sites
You will not qualify if you...
- 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 needing surgery
- Presence of a stoma or an ileoanal pouch
- Total white cell count less than 3.0 x 10^9/L
- Albumin less than 20 g/L
- Immunodeficiency beyond immune suppressants for IBD (e.g., HIV, Common variable immune deficiency)
- Severe allergy or anaphylaxis to food
- Recent dose changes of thiopurine, methotrexate, biologics, small molecule inhibitors, or aminosalicylates within specified timeframes
- Prebiotic, probiotic, antibiotic, or supplement therapy in the 2 weeks prior to study entry
- Rectal topical Crohn's therapy in the 2 weeks prior to study entry
- Prednisolone dose over 20 mg or budesonide dose over 6 mg
- Unwilling or unable to taper corticosteroids to zero within 8 weeks of initial FMT
- Active gastrointestinal infection
- Alcohol dependency
- Primary sclerosing cholangitis
- Any condition posing theoretical risk as judged by gastroenterologist
- Inability to safely participate in FMT as judged by clinicians
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
St Vincents Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
A
Amy Wilson O'Brien
CONTACT
S
Sasha Fehily, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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