Intestinal Ultrasound Guided Management in Inflammatory Bowel Disease

Conditions

• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Aug 20, 2026

Start date

Mar 25, 2026

Status verified

Aug 2026

Primary completion

Feb 29, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

137 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• 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.

Primary Outcome Measure

Proportion of participants with a change in treatment [ Time Frame: 48 weeks ]

Central Contacts

• Thanaboon Chaemsupaphan, MD
  +66 86 896 4889
  [email protected]

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