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Intestinal Ultrasound Guided Management in Inflammatory Bowel Disease

NCT07775352 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2026-08-20

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases
  • Crohn Disease
  • Colitis, Ulcerative

Interventions

DIAGNOSTIC_TEST

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.

OTHER

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.

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Julajak Limsrivilai, MD · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-25
Primary Completion
2028-02-29
Completion
2028-03-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07775352 on ClinicalTrials.gov