A Randomized Controlled Trial Comparing Standard of Care With and Without Intestinal Ultrasound Guidance in Patients With Inflammatory Bowel Diseases
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of inflammatory bowel disease for more than 2 months
• Age 18 years or older
• Undergoing endoscopy at enrollment for assessment of disease severity
Locations
Other Locations
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
RECRUITING
Bangkok
Contact Information
Primary
Thanaboon Chaemsupaphan, MD
ping_tnt@hotmail.com
+66 86 896 4889
Time Frame
Start Date: 2026-03-25
Estimated Completion Date: 2028-03
Participants
Target number of participants: 137
Treatments
Experimental: Standard of care plus intestinal ultrasound
Participants receive standard of care plus point-of-care intestinal ultrasound (IUS) at every study visit. Each IUS examination takes approximately 15 minutes and requires no fasting or bowel preparation. Bowel wall thickness, color Doppler signal, and mesenteric fat hypertrophy are assessed, and the findings are used to guide clinical management.
Active_comparator: Standard of care alone
Participants receive standard of care alone, without intestinal ultrasound. Standard of care includes 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.
Related Therapeutic Areas
Sponsors
Leads: Mahidol University