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Intestinal Ultrasound Guided Management in Inflammatory Bowel Disease
Sponsor: Mahidol University
Summary
This randomized controlled trial evaluates whether adding point-of-care intestinal ultrasound (IUS) to standard of care changes clinical management in patients with inflammatory bowel disease (IBD). Adult patients with Crohn's disease or ulcerative colitis undergoing colonoscopy for disease assessment are randomized 1:1 to standard of care plus IUS at every visit, or standard of care alone, and followed for 48 weeks. The primary outcome is the proportion of patients with a change in treatment.
Official title: A Randomized Controlled Trial Comparing Standard of Care With and Without Intestinal Ultrasound Guidance in Patients With Inflammatory Bowel Diseases
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
137
Start Date
2026-03-25
Completion Date
2028-03
Last Updated
2026-08-20
Healthy Volunteers
No
Interventions
Intestinal ultrasound (IUS)
Point-of-care intestinal ultrasound performed at every study visit by a physician certified by the International Bowel Ultrasound Group (IBUS). The examination takes approximately 15 minutes and requires no fasting or bowel preparation. Bowel wall thickness, color Doppler signal, and mesenteric fat hypertrophy are assessed. The physician performing the examination is blinded to the blood and stool test results obtained on the same day.
Standard of care
Standard of care assessment and management of inflammatory bowel disease, including clinical disease activity scores (partial Mayo/PRO-2 for ulcerative colitis, or Harvey-Bradshaw Index/PRO-2 for Crohn's disease), complete blood count, C-reactive protein, fecal calprotectin, and colonoscopy as clinically indicated.
Locations (1)
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand