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NCT05673278
Non-Invasive Monitoring Through Bowel Ultrasound in Paediatric Inflammatory Bowel Disease Study
Conditions: Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease, Pediatric Crohns Disease, Pediatric Ulcerative Colitis
Sex: All
Ages: 2 Years – 19 Years
Enrollment: 50
Sponsor: Cardiff and Vale University Health Board
Location: United Kingdom
Summary
Rates of inflammatory bowel disease (IBD) are increasing rapidly in children and young people, and targets for management are becoming more demanding, with better control of disease to prevent complications, cancers and surgeries.
This project "Non-Invasive Monitoring Through Bowel Ultrasound in Paediatric Inflammatory Bowel Disease" or NIMBUS study will aim to explore the possibility of using ultrasound to examine inflammation in this group.Monitoring inflammation in this population currently is done with regular endoscopy (camera tests) and/ or MRI enterography scans which are invasive, can be uncomfortable, expensive and may have long waiting lists.
These studies also require bowel prep, in the form of laxative medicines which can be distressing and cause time off from school.
Direct visualisation through ultrasound could allow better monitoring of disease, and is quick, accurate, non-invasive and relatively low-cost.
This could also allow for more appropriate medication use and a decrease in over/under use of medicines.This study will aim to recruit 50 children and young people with inflammatory bowel disease.
Each child will have an ultrasound scan after enrolment and the investigators will use the information from these scans, as well as routine blood tests (already taken in normal care) and follow up medical information to explore the use of ultrasound in this group.
The investigating team will aim to contribute to the global discussion around this topic and if results are positive will aim to improve monitoring for this population managed at the Noah's Ark Children's Hospital for Wales.
Eligibility Criteria
Inclusion Criteria:50 children visiting hospital for clinical appointments (clinic, infusions, endoscopy etc.) or inpatient in hospital with flare of disease.Children with IBD, aged 2-19 years, diagnosed according to the modified Porto criteriaExclusion Criteria:Children who do not have inflammatory bowel diseasePatients who have previously undergone bowel resection (subtotal colectomy, right hemicolectomy or stricturoplasty)Patients or families unable to give informed consentChildren under 2 years of age or patients older than 19 years
Source: ClinicalTrials.gov (NCT05673278). StuddyBuddy aggregates publicly available trial information.