Not Yet RecruitingNot Applicable

Accuracy of Modified Milan Ultrasound Criteria in Assessing Disease Activity and Severity in Moderate-to-Severe Ulcerative Colitis: a Pilot Study

25 participantsStarted 2026-02-01

Plain-language summary

Longitudinal prospective monocentric observational study in which patients to start Mirikizumab for normal clinical practice will be followed for 24 weeks. Based on the findings in the comparison between US (IUS and TPUS) and endoscopy, the study aim is to build up a modified MUC (Milan Ultrasound Criteria) scoring system taking each colonic segment and the rectum into account, developing non-invasive quantitative ultrasound-based criteria to identify patients with active UC and assess its severity.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years * Confirmed diagnosis of UC according to ECCO guidelines * Patients with active moderate-to-severe disease defined as MES ≥ 2 * Patients undergoing advanced therapies with mirikizumab according to clinical judgement * Patients who provide written informed consent Exclusion Criteria: * Age \< 18 years * Patients with unclassified colitis or other gastrointestinal conditions * Patients with current infections or other severe comorbidity, including liver, kidney or cardiac failure, which contraindicate the initiation of advanced therapy * Patients unable or unwilling to provide consent

What they're measuring

To prospectively compare the diagnostic accuracy of modified MUC versus endoscopy (reference standard), in assessing disease activity and severity in UC.

Timeframe: IUS, TPUS and endoscopy will be performed at baseline and at week 24 (±2).

Trial details

NCT IDNCT07358923

SponsorIRCCS San Raffaele

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-10-01