Using bowel ultrasound to predict outcomes in children with severe colitis
Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis (ASC): A Prospective Multicenter Study From the Paediatric IBD Porto Group of ESPGHAN
This study is testing if bowel ultrasound scans can help doctors predict how children with severe colitis will do and when to start more advanced treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 4 sites (Florence, Firenze and 3 other locations) |
| Trial ID | NCT06324500 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prognostic role of bowel ultrasound scans in children diagnosed with acute severe colitis. The study seeks to identify predictors of poor outcomes using this objective tool, which may help in determining the timing for initiating second-line treatments. Given the high mortality rate associated with delayed interventions, the research focuses on validating bowel ultrasound as a reliable method for assessing disease activity and guiding treatment decisions. The study will include children under 18 years old who are hospitalized for acute severe colitis and have a confirmed diagnosis of ulcerative colitis.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years old hospitalized for acute severe colitis with a confirmed diagnosis of ulcerative colitis.
Not a fit: Patients with infectious colitis, those undergoing treatment with anti-TNF alpha agents, or those previously enrolled for a prior acute severe colitis attack may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved individualized treatment strategies for children with acute severe colitis, potentially reducing mortality rates.
How similar studies have performed: Previous studies have shown bowel ultrasound to be a reliable tool in assessing disease activity in children with ulcerative colitis, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged \< 18 years hospitalized for ASC with diagnosis of UC established by the presence of accepted clinical, radiologic, endoscopic, and histologic criteria Exclusion Criteria: * Patients with infectious colitis; * Patients undergoing treatment with anti-TNF alpha agents; * Patients already enrolled during the study period for a previous ASC attack;
Where this trial is running
Florence, Firenze and 3 other locations
- Meyer Children's Hospital IRCCS — Florence, Firenze, Italy (Recruiting)
- Ospedale Maggiore — Bologna, Italy (Recruiting)
- IRCCS Materno Infantile Burlo Garofolo — Trieste, Italy (Recruiting)
- CMED Centro Médico-Quirúrgico de Enfermedades Digestivas — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Paolo Lionetti, MD — Meyer Children's Hospital IRCCS
- Study coordinator: Paolo Lionetti
- Email: paolo.lionetti@meyer.it
- Phone: 3398416059
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.