Restoring gut bacteria in patients with Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effects of fecal microbiota transplantation (FMT) on patients with active Crohn's disease through a double-blind, placebo-controlled design. The study consists of an optimization phase followed by randomization into intervention or placebo groups, with a focus on achieving clinical response thresholds. Patients who respond positively at week 8 will enter a maintenance phase lasting an additional 44 weeks. The FMT will be prepared anaerobically and administered after being freeze-thawed.

Why it matters

Who can join: the full rules

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.

Where it's running

• St Vincents Hospital
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Principal investigator: Michael A Kamm, MD — St Vincents Hospital
• Study coordinator: Amy Wilson O'Brien
• Email: amy.wilson-obrien@svha.org.au
• Phone: 0392311352

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intestinal ultrasound-guided management for inflammatory bowel disease

  This study tests if adding point-of-care intestinal ultrasound at every visit changes treatment decisions for adults with Crohn’s disease or ulcerative colitis undergoing disease assessment.

  Recruiting Mahidol University · Bangkok · NCT07775352

• Self-management program to improve health in inflammatory bowel disease

  A digital self-management program is being tested to see if it helps people with inflammatory bowel disease feel better and manage their symptoms alongside standard care.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT07456566

• Lower GI imaging with a tethered camera capsule

  This test tries a small camera capsule on a string that takes pictures of the lower gut without sedation for adults who are healthy or who have Lynch syndrome, Crohn's disease, or other inflammatory bowel diseases.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07219537

• COMPARE — Newer IBD treatments in children

  This project compares the safety and effectiveness of newer IBD medicines for children with Crohn's disease or ulcerative colitis who did not respond to anti‑TNF treatment.

  Recruiting at 4 sites University of North Carolina, Chapel Hill · Chapel Hill, North Carolina and 3 other locations · NCT07198113

• Wireless thermal capsule to detect gastrointestinal temperature changes

  This study tests a swallowable wireless thermal capsule to see if it can collect temperature data from the GI tract in healthy adults.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07033208

• Examining the link between polyamine levels and inflammatory bowel disease progression

  This study is trying to see if measuring certain substances in the body can help predict how inflammatory bowel diseases like Ulcerative Colitis and Crohn's Disease will progress in patients.

  Recruiting Xijing Hospital · Xi'an, Shaanxi · NCT06995170

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.