Lyophilized fecal microbiota transplant for adults with active ulcerative colitis

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 randomized, double-blind, placebo-controlled Phase 1 feasibility trial will enroll 85 outpatients across three Canadian centres to compare lyophilized fecal microbiota transplantation (LFMT) with placebo in people with active ulcerative colitis. Participants will be randomized to receive LFMT or placebo either as an adjunct to their existing therapy or when initiating or switching to a new advanced agent. The study uses an oral, lyophilized FMT product and focuses on safety, tolerability, and early signals of clinical benefit to determine whether a full-scale randomized controlled trial is feasible. Standard clinical and laboratory monitoring will be performed and patients with severe or complicated disease are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years of age or older
2. Able to provide informed consent
3. Established UC diagnosis through standard endoscopic and histologic criteria
4. Active UC
5. Use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the duration of the trial
6. Willing and able to comply with all required study procedures

Exclusion Criteria:

1. Severe UC requiring hospitalization
2. Crohn's disease or indeterminate colitis
3. Irritable bowel syndrome
4. Intestinal infection within 4 weeks of enrollment
5. Evidence of toxic megacolon or gastrointestinal perforation on imaging
6. Planned colectomy
7. Abdominal surgery within 60 days of enrollment
8. Neutropenia with absolute neutrophil count \<0.5 x 109/L
9. Peripheral white blood cell count \> 35.0 x 109/L and fever (\>38C)
10. Planned or actively taking another investigational product
11. Uncontrolled medical conditions such as psychiatric disorders or substance abuse
12. Severe underlying disease such that the patient is not expected to survive for at least 30 days
13. Pregnancy or breastfeeding
14. Unwilling to discontinue non-dietary probiotic
15. Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study
16. FMT for any reason within 6 months of enrollment
17. Investigator's judgement that enrolment is not in the best interest of the patient

Where it's running

• University of Alberta
  Edmonton, Alberta, Canada Recruiting
• University of Calgary
  Calgary, Alberta, Canada Not yet recruiting

Study contacts

• Study coordinator: Dina Kao, MD,FRCPC
• Email: dkao@ualberta.ca
• Phone: 780-492-5257

Similar studies

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

• Ath-063: Testing a new treatment for moderately to severely active ulcerative colitis in patients who have tried other biologics

  This study tests ATH-063 to see if it helps people with moderate to severe ulcerative colitis who did not respond to or relapsed after prior biologic therapy.

  Recruiting at 4 sites Phase 2 Athos Therapeutics Inc · Miami, Florida and 3 other locations · NCT07513181

• 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

• Long-acting antibody treatments alone and in combinations for moderate to severe ulcerative colitis

  This tests long-acting antibody medicines, given after an IV induction and then as under-the-skin maintenance, to see if they help adults with moderate to severe ulcerative colitis.

  Recruiting at 276 sites Phase 2 Spyre Therapeutics, Inc. · Canoga Park, California and 275 other locations · NCT07012395

• Observational study comparing inflammatory markers in IBD and non-IBD participants

  This study is trying to see how inflammation levels in people with Crohn's Disease and Ulcerative Colitis compare to those without these conditions when they start new treatments.

  Recruiting University of Nottingham · Nottingham, Nottinghamshire · NCT06956703

• Evaluating robotic surgery for inflammatory bowel disease

  This study is testing if robotic surgery can be a good option for adults with inflammatory bowel disease, like Crohn's or ulcerative colitis, compared to traditional surgery methods.

  Recruiting at 6 sites University Hospitals Coventry and Warwickshire NHS Trust · Coventry, West Midlands and 5 other locations · NCT06579443

• BOOM-IBD2 Pivotal Neuromodulation for Ulcerative Colitis

  This study tries a small device placed under the skin that sends mild signals to a nerve near the tailbone to reduce bowel urgency in adults with ulcerative colitis.

  Recruiting at 16 sites Boomerang Medical · Folsom, California and 18 other locations · NCT06571669

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.