Clinical trial NCT06693310: STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission
Official title: STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ulcerative Colitis (UC)
Keywords: histological remission
de-escalation of therapy
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.
3. Patients in clinical, biochemical (fecal calprotectin \<100), radiologic and endoscopic remission for at least 6 months.

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 dysplasia (suspected or confirmed).
5. Inability to follow the proposed sample collection and monitoring protocol.

Primary outcomes:
measure: Number of individuals with sustained biochemical remission
timeFrame: Baseline, 12 months
measure: Number of individuals with sustained sonographic remission
timeFrame: Baseline, 12 months
measure: Number of individuals with sustained clinical remission
timeFrame: Baseline, 12 months
measure: Number of individuals with sustained endoscopic remission
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Proportion of individuals maintaining corticosteroid-free remission
timeFrame: 12 months
measure: Change in host metabolites in states of deep remission
timeFrame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
measure: Change in microbial metabolites in states of deep remission
timeFrame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
measure: Change in host metabolites in states of disease relapse
timeFrame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
measure: Change in microbial metabolites in states of disease relapse
timeFrame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
measure: Change in microbial composition in states of deep remission
timeFrame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
measure: Change in microbial abundance in states of deep remission
timeFrame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
measure: Change in microbial composition in states of disease relapse
timeFrame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
measure: Change in microbial abundance in states of disease relapse
timeFrame: Baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)
measure: Number of individuals with long-term remission
timeFrame: Month 24
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: David T Rubin, MD
role: PRINCIPAL_INVESTIGATOR
References: