Outpatient pathway for severe ulcerative colitis in the right care setting
Official title: Shifting Acute Severe Ulcerative Colitis Away from the Hospital: A Pilot Randomized Trial of Outpatient ASUC Management
Funded at University of Michigan at Ann Arbor · NIH-11438442 · Data updated 2026-11-12
This study tests a safe, outpatient approach using an oral therapy and remote monitoring for people with acute severe ulcerative colitis to avoid hospitalization.
Quick facts
| Grant type | R03 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Michigan at Ann Arbor NIH-funded |
| Lab location | 1 site (Ann Arbor, United States) |
| Project start | August 13, 2026 |
| Project end | July 31, 2028 |
| Funding year | 2026 |
| Award (this year) | $117,000 |
| NIH project number | 1R03DK149488-01 |
| Project ID | NIH-11438442 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with acute severe ulcerative colitis who meet outpatient criteria and are suitable for an outpatient management plan.
✕Less likely to help
People with severe disease needing urgent in-hospital care or contraindications to oral JAK inhibitors may not benefit from this approach.
What this research studies
Acute severe ulcerative colitis (ASUC) has long required hospital stays for IV steroids, a process that is burdensome for patients. This pilot trial will test an outpatient management plan that includes early intensified oral therapy with a JAK inhibitor and structured remote monitoring, plus clear criteria for when hospitalization or rescue treatment is needed. We will enroll 30 outpatients with ASUC in a randomized, double-blind, placebo-controlled design to gather essential safety and feasibility data. The goal is to establish a pathway that could support a larger, definitive trial and potentially shift care away from the hospital for select patients. The study builds on prior inpatient ASUC work and aims to create a patient-centered, cost-conscious model of care.
Why it matters
Potential benefit: If successful, patients with ASUC may be able to manage episodes at home with close monitoring, reducing hospital stays and healthcare costs.
How similar studies have gone: Previous inpatient ASUC trials support the feasibility of structured management, but outpatient randomized data are not yet established, making this investigation novel for outpatient care.
Where this research is happening
-
University of Michigan at Ann Arbor
Ann Arbor, United States Active
Researchers
- Principal investigator: Berinstein, Jeffrey — University of Michigan at Ann Arbor
- Study coordinator: Berinstein, Jeffrey
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.