Ulcerative Colitis (UC)
Reducing Ulcerative Colitis Treatment During Deep Remission
Researchers are comparing continued maintenance therapy with reduced or discontinued therapy in adults whose ulcerative colitis shows sustained clinical, biochemical, imaging, endoscopic, and histologic remission.
Registry title: STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- de-escalation or discontinuation of therapy or continuation of current therapy
- Design
- Non Randomized
- Central study contact
- Research Coordinator215-596-9715Alex.Mathew@bsd.uchicago.edu
- Sponsor
- University of Chicago
Research question
Can people with ulcerative colitis in deep remission maintain remission after reducing or stopping maintenance therapy compared with continuing their current therapy?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 to 75 with ulcerative colitis diagnosed at least three years ago.
- The study is looking for people in clinical, biochemical, imaging, endoscopic, and histologic remission.
- The study is looking for people whose qualifying colonoscopy and biopsies showed no active inflammation, generally within the past 12 months.
- Participants must be able to follow the study's sample-collection and monitoring protocol.
- The listed recruiting site is the University of Chicago in Chicago, Illinois.
Participation overview
What participation may involve
Participants continue their current therapy or reduce or stop it, receive regular clinical care, undergo monitoring, and provide research samples. Active monitoring lasts 24 months, followed by five years of routine-care data collection for participants who remain in remission. What participation may involve: - Continue current ulcerative colitis maintenance therapy or follow the study's de-escalation or discontinuation strategy. - Receive clinical management according to regular medical care. - Provide blood, stool, and tissue samples for study purposes. - Complete symptom assessment using the two-item Patient-Reported Outcome measure covering stool frequency and rectal bleeding. - Undergo assessments of biochemical, ultrasound, clinical, and endoscopic remission. Participants are monitored for 24 months. Those still in remission afterward have five additional years of longitudinal data collected from routine clinical care.
Study interventions
What participants may receive or do
- de-escalation or discontinuation of therapy: Participants in this group step down from an advanced therapy to an oral aminosalicylate, or stop therapy when aminosalicylates are unsuitable. Those taking an immunomodulator or oral aminosalicylate stop that maintenance therapy.
- continuation of current therapy: Participants in this comparison group continue their current maintenance medical therapy for ulcerative colitis.
Study design
How the comparison works
This open-label, parallel-group study compares therapy de-escalation with continuation. Participants with a strong preference choose a strategy, while those without a clear preference are described as being assigned randomly in equal proportions. The detailed description says participants without a clear preference are randomized 1:1, but the structured allocation field labels the study non-randomized. The study team should clarify how assignment is recorded and performed. The study uses no masking, so participants and researchers know whether therapy is continued or de-escalated. The active comparison group continues its current ulcerative colitis maintenance therapy. No placebo or sham intervention is listed; the two strategies are continued therapy and therapy de-escalation or discontinuation.
Reported activities
Procedures and tests
- Blood collection for study purposes.
- Stool collection for study purposes.
- Tissue collection for study purposes.
- Fecal calprotectin testing to assess biochemical remission.
- C-reactive protein blood testing to assess biochemical remission.
- Intestinal ultrasound to measure bowel-wall thickness and assess sonographic remission.
- The two-item Patient-Reported Outcome questionnaire to record stool frequency and rectal bleeding.
- Endoscopic assessment using the Mayo endoscopic subscore.
- Laboratory analysis may include mass spectrometry, flow cytometry, enzyme-linked immunosorbent assays, and real-time polymerase chain reaction assays.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 to 75 years old, consent to participate, and have had an established ulcerative colitis diagnosis for at least three years.
- Participants must be in deep remission, with all biopsies from a colonoscopy within the last 12 months showing no active endoscopic or histologic inflammation.
- An exception may apply when a colonoscopy within the last three years showed stable normalized or inactive histology: persistently normal calprotectin with no therapy change may be accepted.
- Participants must have remained in clinical, biochemical, imaging, and endoscopic remission since their last colonoscopy, including fecal calprotectin below 100.
Possible reasons someone may not be able to join
- Any active clinical, ultrasound, biochemical, or endoscopic inflammation, including inflammation in any colon segment, excludes participation.
- A therapy change after the colonoscopy that showed histologic normalization or quiescence excludes participation.
- Corticosteroid use after the colonoscopy that showed histologic normalization or quiescence excludes participation.
- People with any history of primary sclerosing cholangitis are excluded.
- Suspected or confirmed invisible or unresected high-grade dysplasia excludes participation.
- People who are pregnant or actively trying to conceive are excluded.
- People unable to follow the proposed sample-collection and monitoring protocol are excluded.
Important unknowns
What the record does not make clear
- The record mentions expected assessments at 6, 12, 18, and 24 months but does not provide a complete visit schedule or distinguish clinic visits from sample collection and routine care.
- The record describes broad de-escalation rules but does not give individualized transition plans or explain which other ulcerative colitis medicines may continue.
- No washout or tapering schedule is reported for therapies being reduced or discontinued.
- The record does not explain what treatment is offered if symptoms or inflammation return.
- Endoscopic remission is measured at baseline and 12 months, but the record does not clearly state which study colonoscopies or endoscopies participants must undergo.
- The record does not state which care, medicines, tests, or research procedures are paid by the study or billed to insurance.
- The record does not report whether participants receive compensation.
- The record lists one Chicago site but does not report reimbursement or other travel support.
- The record does not say whether any monitoring, questionnaires, or sample collection can occur remotely or locally.
- The detailed description calls the trial partially randomized and describes 1:1 randomization for participants without a preference, while the structured design field says non-randomized.
Before contacting the site
Questions for the study team
- What is the complete schedule of visits, tests, sample collections, and remote contacts during the 24-month monitoring period?
- How is treatment assignment determined for someone who has no strong preference, given the conflicting randomization descriptions?
- Exactly how would my current therapy be reduced or stopped, and which medicines would continue?
- What symptoms, laboratory results, ultrasound findings, or endoscopy findings would trigger treatment restart or another rescue plan?
- Which colonoscopies or other endoscopic procedures are required after enrollment?
- Which costs are covered, is compensation available, and is travel assistance offered for the Chicago site?
Before changing care
Questions for your gastroenterologist
- How stable has my ulcerative colitis remission been across symptoms, calprotectin, blood tests, imaging, endoscopy, and biopsies?
- What are the clinical risks and reasonable alternatives to reducing or stopping my current maintenance therapy?
- If my disease activity returns, what treatment plan would you recommend, and how should it be coordinated with the research team?
- Would study-related treatment changes affect my other conditions, medicines, or routine ulcerative colitis monitoring?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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
This is a prospective, partially-randomized, patient-preference clinical trial conducted at a tertiary academic center \[University of Chicago Medicine Inflammatory Bowel Disease (IBD) Center\]. 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. Subjects will be given a choice to either de-escalate their therapy (de-escalation group) or continue their current therapy (control group). This study design is to enhance the feasibility and real-world applicability. By permitting participants with strong preferences to choose their assigned strategy, we anticipate higher enrollment and retention among eligible subjects who might otherwise decline participation. Participants without a clear preference will be randomized 1:1 to de-escalation versus continuation, thereby preserving the integrity of comparative analyses. This approach enhances generalizability, respects patient autonomy, and mirrors clinical decision-making in routine clinical practice while maintaining methodological rigor. After enrollment, participants will be monitored for 24 months. After the 24-month period, participants who remain in remission will continue 5 years of longitudinal data collection from routine clinical care.
Study design and administration
- Organization
- University of Chicago
- Organization class
- Other
- Organization study ID
- IRB24-0008
- Lead sponsor
- University of Chicago
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Non Randomized
- Intervention model
- Parallel
- Primary purpose
- Other
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Active Comparator
Control group
continuation of current therapy
Interventions: Other: continuation of current therapy
Active Comparator
de-escalation group
de-escalation or discontinuation of therapy
Interventions: Other: de-escalation or discontinuation of therapy
Interventions
Other
de-escalation or discontinuation of therapy
De-escalation of therapy, defined as a step-down from maintenance with advanced therapy (biologic or synthetic small molecule) to oral aminosalicylate-based therapy or complete discontinuation of therapy if they are allergic or intolerant to aminosalicylate-based therapy. If patients are receiving immunomodulator or oral aminosalicylate maintenance therapy, they will be de-escalated to complete discontinuation of therapy.
Other
continuation of current therapy
continuation of current maintenance medical therapy for ulcerative colitis
Eligibility
18 Years–75 Years
All
Not accepted
Inclusion criteria (4)
- Consenting patients aged 18 to 75 years with an established diagnosis of ulcerative colitis (UC) for at least 3 years.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Patients in clinical, biochemical (fecal calprotectin \<100), radiologic and endoscopic remission since the last colonoscopy.Registry-derived · unreviewed
Exclusion criteria (6)
- Any noted active inflammation \[clinical, sonographic, biochemical, endoscopic (in any colonic segment)\].Registry-derived · unreviewed
- Patients with any changes in therapy after colonoscopy showing histological normalization or quiescence.Registry-derived · unreviewed
- Corticosteroid use after colonoscopy showing histologic normalization or quiescence.Registry-derived · unreviewed
- Patients with any noted history of primary sclerosing cholangitis or invisible or unresected high-grade dysplasia (suspected or confirmed).Registry-derived · unreviewed
- Pregnancy or actively trying to conceiveRegistry-derived · unreviewed
- Inability to follow the proposed sample collection and monitoring protocol.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Number of individuals with sustained biochemical remission
Time frame: Baseline, 12 months
Biochemical remission defined as fecal calprotectin (FCP) level less than 150 and C-reactive protein (CRP) level less than the predetermined normal range according to the test manufacturer (typically less than 5.0mg/dL).
Primary outcome
Number of individuals with sustained sonographic remission
Time frame: Baseline, 12 months
Sonographic remission defined as bowel wall thickness (BWT) less than 4 millimeters(mm) in rectum and BWT less than 3 mm in the remainder of the bowel; measured by intestinal ultrasound
Primary outcome
Number of individuals with sustained clinical remission
Time frame: Baseline, 12 months
Clinical remission defined as Patient-Reported Outcome (PRO-2) score less than 1. The PRO-2 questionnaire measures patient-reported stool frequency and rectal bleeding in UC; scores range from 0-3, with higher scores indicating more severe symptoms.
Primary outcome
Number of individuals with sustained endoscopic remission
Time frame: Baseline, 12 months
Endoscopic remission defined as Mayo endoscopic subscore equal to 0 or 1. The Mayo endoscopic subscore is a physician-reported measure of mucosal appearance at endoscopy. Scores range from 0-3, with higher scores indicating more disease activity.
Secondary outcome
Proportion of individuals maintaining corticosteroid-free remission
Time frame: 12 months
Calculated by dividing the number of individuals maintaining remission without the need for corticosteroid medications by the total number of individuals in the study
Secondary outcome
Change in host metabolites in states of deep remission
Time frame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
Measured by mass spectrometry, flow cytometry, enzyme-linked immunosorbent assay (ELISA)-based assays and/or real-time polymerase chain reaction (RT-PCR)-based assays
Secondary outcome
Change in microbial metabolites in states of deep remission
Time frame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
Quantitative measurement of host metabolites using mass spectrometry, flow cytometry, enzyme-linked immunosorbent assays (ELISA), and/or real-time polymerase chain reaction (RT-PCR)-based assays to characterize biochemical changes associated with deep remission
Secondary outcome
Change in host metabolites in states of disease relapse
Time frame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
Measured by mass spectrometry, flow cytometry, ELISA-based assays and/or RT-PCR-based assays
Secondary outcome
Change in microbial metabolites in states of disease relapse
Time frame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
Measured by mass spectrometry, flow cytometry, ELISA-based assays and/or RT-PCR-based assays
Secondary outcome
Change in microbial composition in states of deep remission
Time frame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
Measured by mass spectrometry and RT-PCR-based assays
Secondary outcome
Change in microbial abundance in states of deep remission
Time frame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
Measured by RT-PCR-based assays
Secondary outcome
Change in microbial composition in states of disease relapse
Time frame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
Measured by RT-PCR-based assays
Secondary outcome
Change in microbial abundance in states of disease relapse
Time frame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
Measured by RT-PCR-based assays
Secondary outcome
Number of individuals with long-term remission
Time frame: Month 24
Remission defined as an individual with all of the following: 1. Clinical remission: PRO-2 less than 1 2. Biochemical remission: FCP less than 150, CRP less than 1.0 mg/dL 3. Sonographic remission: BWT ultrasound assessment less than 4mm in Rectum; less than 3mm in remainder of Bowel 4. Endoscopic remission: Mayo Endoscopic Subscore equals 0 or 1
Recruiting locations in the United States
University of Chicago
RecruitingChicago, Illinois, 60637, United States
David T Rubin, MD
Central study contacts
Registry dates
- First posted
- Nov 18, 2024
- Primary completion
- Nov 2026
- Overall completion
- Nov 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.