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RECRUITING Not applicable ClinicalTrials.gov

Intestinal Ultrasound Guided Management in Inflammatory Bowel Disease

Sponsor: Mahidol University • ClinicalTrials.gov ID: NCT07775352

Registry updated: 2026-10-14
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Description

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.

Interventions

  • Intestinal ultrasound (IUS) (Diagnostic test)
    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 (Other)
    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.

Eligibility criteria

Inclusion Criteria: * Diagnosis of inflammatory bowel disease for more than 2 months * Age 18 years or older * Undergoing endoscopy at enrollment for assessment of disease severity Exclusion Criteria: * Pregnancy * Unstable underlying medical conditions * Inflammatory bowel disease limited to the distal rectum (within 10 cm of the anal verge) or perianal disease only * Biologic failure

Conditions

Inflammatory Bowel Diseases Crohn Disease Colitis, Ulcerative

Locations

  • Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok, Thailand
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record