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

NCT07358923 | Not Yet Recruiting

• 1 other identifier: Modified MUC
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

• 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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Biospecimen

Retention: SAMPLES WITH DNA

Colon biopsies

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01