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

January 14, 2026 updated by: Mariangela Allocca, IRCCS San Raffaele
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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population is a population of adult patients with confirmed diagnosis of UC according to ECCO guidelines with an active moderate-to-severe disease defined as MES ≥ 2 and who have indication to undergo advanced therapies with mirikizumab according to clinical judgement

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Modified MUC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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