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

Starting soon

Conditions studied: Ulcerative Colitis (UC)

In brief

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.

Key facts

Study ID

NCT07358923

Run by

IRCCS San Raffaele

People needed

25

Starts

2026-02-01

Expected to finish

2027-10-01

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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