Microbial Restoration in Inflammatory Bowel Diseases

Launched by ST VINCENT'S HOSPITAL MELBOURNE · Jul 18, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called fecal microbiota transplantation (FMT) on patients with active Crohn's disease, which is a type of inflammatory bowel disease. The trial is being conducted at two locations and aims to find out if FMT can help improve symptoms in people who are currently experiencing active disease. The study is open to all genders and is currently looking for participants aged between 18 and 80 years who have been diagnosed with active Crohn's disease.

To qualify for the trial, participants must have active Crohn's disease but should not have certain complications, such as severe anal disease or other gastrointestinal conditions. Pregnant individuals and those with specific health issues, like a weakened immune system or recent infections, are not eligible. If you decide to participate, you will receive either the FMT treatment or a placebo (a treatment that looks the same but has no active ingredients) without knowing which one you receive, as this is a double-blind study. This helps ensure the results are fair and unbiased. If you're interested in learning more about joining this trial, consider discussing it with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.