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STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 months
  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients in clinical, biochemical, and endoscopic remission with biopsies showing histologic quiescence or normalization will be identified and approached after consultation with their IBD care team."
  • "After enrollment, participants will be monitored for 24 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with ulcerative colitis (UC), a disease that causes swelling and sores in the colon, whose disease is not active. It compares staying on treatment with lowering or stopping treatment to see if UC stays inactive. Both choices are part of regular medical care.

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: * either be randomly assigned to continue medical therapy or de-escalate medical therapy -OR- be assigned per the participant's preference * clinically managed according to regular medical care * asked to provide blood, stool (poop), and tissue samples for study purposes

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 75 years old, agree to join, and have had UC for at least 3 years.
  • A colonoscopy in the past 12 months showed no active swelling, and all tissue samples showed no active disease. A colonoscopy uses a camera to look inside the colon.
  • If your last colonoscopy was within 3 years and showed no active disease in tissue samples, repeated normal stool inflammation tests may be accepted instead. Your treatment must not have changed.
  • Since your last colonoscopy, symptoms, scans, stool tests, and colon exams must show no active disease. Your stool calprotectin level, a measure of inflammation, must be below 100.

Who can't join

  • You have any signs of active inflammation, including symptoms or findings on ultrasound, lab tests, or a colon exam.
  • Your treatment changed after the colonoscopy that showed no active disease in tissue samples.
  • You used corticosteroids, medicines that reduce inflammation, after that colonoscopy.
  • You have ever had primary sclerosing cholangitis, a disease that scars the tubes carrying bile from the liver.
  • You have suspected or confirmed high-grade dysplasia—very abnormal cells that may turn into cancer—that cannot be seen during a colon exam or has not been removed.
  • You are pregnant or actively trying to get pregnant.
  • You cannot follow the study's sample collection and health check plan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

IL