De-escalating treatment for ulcerative colitis when biopsies show no inflammation

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 is a prospective, partially randomized, patient-preference study at the University of Chicago enrolling adults with long-standing ulcerative colitis in deep clinical, endoscopic, biochemical, and histologic remission. Participants may choose to either continue their current medical therapy or de-escalate (decrease or stop) therapy, and those without a clear preference are randomized 1:1. Subjects are followed with routine clinical management and sampled for blood, stool, and tissue, with active monitoring for 24 months and longer-term data collected up to five years for those who remain in remission. The design is intended to reflect real-world decision making while preserving comparative rigor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Consenting patients aged 18 to 75 years with an established diagnosis of ulcerative colitis (UC) for at least 3 years.
2. Patients in deep remission, defined by the absence of endoscopic and histologic signs of active inflammation (i.e. histological normalization or histological quiescence) in all biopsies obtained during colonoscopy, within the last 12 months.

   * If the most recent colonoscopy is within the last 3 years and demonstrates normalized/quiescent pathology findings (i.e., patient is in stable remission), the patient would not be expected to undergo yearly colonoscopies. Therefore, a persistent normalized calprotectin test will be accepted as sufficient to define deep remission with no change in therapy.
3. Patients in clinical, biochemical (fecal calprotectin \<100), radiologic and endoscopic remission since the last colonoscopy.

Exclusion Criteria:

1. Any noted active inflammation \[clinical, sonographic, biochemical, endoscopic (in any colonic segment)\].
2. Patients with any changes in therapy after colonoscopy showing histological normalization or quiescence.
3. Corticosteroid use after colonoscopy showing histologic normalization or quiescence.
4. Patients with any noted history of primary sclerosing cholangitis or invisible or unresected high-grade dysplasia (suspected or confirmed).
5. Pregnancy or actively trying to conceive
6. Inability to follow the proposed sample collection and monitoring protocol.

Where it's running

• University of Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: David T Rubin, MD — University of Chicago
• Study coordinator: Research Coordinator
• Email: Alex.Mathew@bsd.uchicago.edu
• Phone: 215-596-9715

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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.