Accuracy of Modified Milan Ultrasound Criteria in Assessing Disease Activity and Severity in Moderate-to-Severe Ulcerative Colitis: a Pilot Study
Observational · No treatment assigned · Sites not listed yet · IRCCS San Raffaele
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis (UC). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Age ≥ 18 years
- Confirmed diagnosis of UC according to ECCO guidelines
- Patients with active moderate-to-severe disease defined as MES
Plus 3 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 25 participants are expected to take part.
- Start date: 2026-02-01 (planned).
- Main results expected around 2026-10-01 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- 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).)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | IRCCS San Raffaele |
| Enrollment | 25 (estimated) |
| Start date | 2026-02-01 |
| Primary completion (est.) | 2026-10-01 |
| First posted | 2026-01-22 |
| Last updated | 2026-01-22 |
| Official title | Accuracy of Modified Milan Ultrasound Criteria in Assessing Disease Activity and Severity in Moderate-to-Severe Ulcerative Colitis: a Pilot Study |
| ClinicalTrials.gov ID | NCT07358923 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.