Therapy De-escalation for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

Overseen byDavid T Rubin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this study is to better understand treatment strategies for people with ulcerative colitis (UC). Researchers will compare patients with UC in histologic remission (no evidence of inflammation or active disease on endoscopy and biopsies) who continue to take medical therapy to patients with UC who de-escalate (decrease or discontinue) medical therapy. Both treatment strategies are considered within regular medical practice. Researchers want to find out whether remission can be maintained after de-escalation of therapy. Participants will be: * randomly assigned to continue medical therapy or de-escalate medical therapy * clinically managed according to regular medical care * asked to provide blood, stool (poop), and tissue samples for study purposes

Research Team

David T Rubin, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for people with ulcerative colitis who show no signs of inflammation or active disease. They must be in histological remission, meaning their endoscopy and biopsies are clear. The study excludes details not provided.

Inclusion Criteria

I am between 18 and 75 years old and have been diagnosed with ulcerative colitis for at least 3 years.

My inflammatory bowel disease has been in remission for at least 6 months.

My recent tests show no signs of active inflammation in my colon.

Exclusion Criteria

My treatment changed after a colonoscopy showed my colon is now normal or inactive.

I am using corticosteroids after my colonoscopy showed normal or inactive disease.

I have a history of primary sclerosing cholangitis or dysplasia.

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Treatment Details

Interventions

De-escalation of Therapy (Behavioural Intervention)

Trial OverviewThe STOP-UC trial compares two approaches: continuing current medical therapy versus decreasing or stopping it altogether for those in remission from ulcerative colitis. Participants will be randomly placed into one of these groups.

Participant Groups

2Treatment groups

Active Control

Group I: de-escalation groupActive Control1 Intervention

de-escalation or discontinuation of therapy

Group II: Control groupActive Control1 Intervention

continuation of current therapy