STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission
- Conditions
- Ulcerative Colitis (UC)
- Registration Number
- NCT06693310
- Lead Sponsor
- University of Chicago
- Brief Summary
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
- Detailed Description
This is a prospective, randomized 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. After enrollment, participants will be randomized to either de-escalation of therapy (de-escalation group) or continuation of current therapy (control group) and monitored for 24 months, both consistent with current clinical practice. After the 24-month period, participants who remain in remission will continue 5 years of longitudinal data collection from routine clinical care.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Consenting patients aged 18 to 75 years with an established diagnosis of ulcerative colitis (UC) for at least 3 years.
- 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.
- Patients in clinical, biochemical (fecal calprotectin <100), radiologic and endoscopic remission for at least 6 months.
- Any noted active inflammation [clinical, sonographic, biochemical, endoscopic (in any colonic segment)].
- Patients with any changes in therapy after colonoscopy showing histological normalization or quiescence.
- Corticosteroid use after colonoscopy showing histologic normalization or quiescence.
- Patients with any noted history of primary sclerosing cholangitis or dysplasia (suspected or confirmed).
- Inability to follow the proposed sample collection and monitoring protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of individuals with sustained biochemical remission 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).
Number of individuals with sustained sonographic remission 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
Number of individuals with sustained clinical remission 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.
Number of individuals with sustained endoscopic remission 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 Measures
Name Time Method Proportion of individuals maintaining corticosteroid-free remission 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
Change in host metabolites in states of deep remission 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
Change in microbial metabolites in states of deep remission 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
Change in host metabolites in states of disease relapse 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
Change in microbial metabolites in states of disease relapse 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
Change in microbial composition in states of deep remission 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
Change in microbial abundance in states of deep remission 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
Change in microbial composition in states of disease relapse 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
Change in microbial abundance in states of disease relapse 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
Number of individuals with long-term remission 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
Trial Locations
- Locations (1)
University of Chicago
🇺🇸Chicago, Illinois, United States