Microbial Restoration in Inflammatory Bowel Diseases

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Fecal Microbiota Transplantation, Crohn Disease, Inflammatory Bowel Diseases, Microbiome

In brief

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.

Key facts

Study ID

NCT04970446

Run by

St Vincent's Hospital Melbourne

People needed

120

Starts

2022-05-01

Expected to finish

2026-04-01

Last updated by the study team

2025-02-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• St Vincents Hospital — Melbourne, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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