Clinical Trial

Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis

Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
The goal of this trial is to create personalized treatments for each patient admitted to the hospital with acute severe ulcerative colitis (ASUC). The study will test the feasibility and acceptability of these treatment strategies among patients and physicians so that the study team can later do a larger trial to test whether the medication treatment pathways help patients avoid colectomy while ensuring patient's are safe.
Protocol Amendment History 4 changes
critical Primary endpoint(s) modified 2026-08-12
notable Enrollment increased: 162 -> 700 participants 2026-08-12
notable Primary completion pushed: 2026-05 -> 2027-11 2026-08-12
minor Completion pushed: 2026-05 -> 2027-11 2026-08-12
Trial Details
NCT Number NCT05867329
Lead Sponsor Berinstein, Jeffrey
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Ulcerative Colitis Acute
Enrollment 700 participants
Start Date 2023-09-30
Primary Completion 2027-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-11