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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07358923

Enrollment

Registered

2026-01-22

Start date

2026-02-01

Completion date

2027-10-01

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis (UC)

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To prospectively compare the diagnostic accuracy of modified MUC versus endoscopy (reference standard), in assessing disease activity and severity in UC.	IUS, TPUS and endoscopy will be performed at baseline and at week 24 (±2).

Outcome results