Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT05327790 Sponsor: University of Alberta Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT05327790
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 74 years old
  • You are able to give your own consent to participate in the study
  • A doctor has confirmed you have ulcerative colitis (UC) based on standard tests including a camera examination of your bowel and tissue samples
  • Your UC is currently active and moderately-to-severely symptomatic, with inflammation reaching at least 15 cm inside your bowel (confirm with trial site for exact scoring details)
  • Your doctor has chosen to start you on one of two specific biologic medications: vedolizumab or ustekinumab — and you have either never had a biologic treatment before, OR previous biologic or similar treatments have not worked for you
  • If you are a woman who could become pregnant, you are using reliable contraception for at least 4 weeks before and throughout the study
  • You are willing and able to follow all study requirements

Who may not be able to join:

  • Your UC is severe enough that you need to be treated in hospital
  • Your diagnosis is uncertain and not clearly confirmed as ulcerative colitis
  • You have had a bowel infection (such as C. difficile or CMV) or been treated for one in the past 4 weeks
  • Imaging has shown serious bowel complications such as a dangerously enlarged colon or a hole in the bowel wall
  • You have had abdominal surgery in the past 60 days
  • You have a very low white blood cell count, or a very high white blood cell count combined with a fever (confirm with trial site for exact values)
  • You are currently taking or planning to take another experimental treatment
  • You have uncontrolled health conditions such as serious mental health disorders or substance misuse problems
  • You have a serious illness that means you are not expected to live for at least 30 more days
  • You are pregnant or breastfeeding
  • You are unwilling to stop taking non-dietary probiotic supplements
  • You have used antibiotics in the past 30 days, or are likely to need antibiotic treatment during the study
  • You have had a fecal microbiota transplant (a procedure involving stool from a donor) within the past 3 months
  • You have recently used certain medications, including rectal or topical bowel treatments, immunosuppressants, or specific biologic drugs within certain time periods before the study (confirm exact medications and timeframes with trial site)
  • The study doctor does not feel that joining this trial is in your best interest

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
3 June 2022
Est. completion
31 March 2027

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Proportion of participants with serious adverse events (SAEs) of interest up to week 8 in each group (ie vedolizumab with or without LFMT, ustekinumab with or without LFMT).

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov