High-end versus mid-end intestinal ultrasound for finding ileocolonic inflammation in IBD

Comparing Diagnostic Accuracy of High-End Intestinal Ultrasound Versus Mid-End Ultrasound With Tandem Ileo-Colonoscopy in Inflammatory Bowel Disease (The HUMID Study): A Paired, Validating Confirmatory Study

This study tests whether a high-end intestinal ultrasound machine finds inflammation in the ileum and colon of adults with IBD more accurately than a mid-end ultrasound, using colonoscopy as the comparison.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Asian Institute of Gastroenterology, India (Academic / other)
• Locations: 1 site (Hyderabad, Telangana)
• Trial ID: NCT06938295 on ClinicalTrials.gov

What this trial studies

This is a prospective, cross-sectional, paired diagnostic accuracy study comparing a high-end (Samsung RS85) and a mid-end (Siemens ACUSON S2000) intestinal ultrasound system for detecting ileocolonic inflammation in patients with inflammatory bowel disease. Enrolled adults will have two back-to-back ultrasound examinations performed by different blinded operators followed by ileo-colonoscopy as the reference standard on the same day. Ultrasound measures will include bowel wall thickness, mural stratification, vascularity, and disease extent, and diagnostic accuracy metrics (sensitivity, specificity, PPV, NPV) will be calculated for each machine. Secondary analyses will examine how ultrasound findings influence clinical management and potential cost implications for resource-limited settings.

Who should consider this trial

Good fit: Adults aged 18–75 with a confirmed diagnosis of IBD involving the colon and/or terminal ileum who are clinically stable and willing to undergo two ultrasounds and ileo-colonoscopy are ideal candidates.

Not a fit: Patients who are pregnant or breastfeeding, unable to undergo colonoscopy, have conditions that prevent clear ultrasound imaging (for example severe obesity or uncooperative behaviour), or whose disease does not involve the ileum or colon are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could support using more affordable mid-end ultrasound equipment to reliably detect ileocolonic inflammation, expanding access to accurate IBD imaging in resource-limited settings.

How similar studies have performed: Prior work shows intestinal ultrasound can reliably detect ileocolonic inflammation, but direct paired comparisons of high-end versus mid-end machines against colonoscopy are limited, so this head-to-head validation is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Patients aged 18-75 years.
* Confirmed diagnosis of inflammatory bowel disease (IBD), specifically with ileocolonic involvement.
* Clinically stable at the time of assessment.
* Willing and able to undergo both intestinal ultrasound (IUS) assessments (mid-end and high-end) and the reference standard ileo-colonoscopy.
* Provides informed consent to participate in the study.

Exclusion Criteria:

* Pregnant or breastfeeding individuals.
* Patients with contraindications to ileo-colonoscopy (e.g., severe comorbidities, known intolerance).
* Individuals unable to provide informed consent.
* Patients with conditions interfering with ultrasound imaging, such as severe obesity or uncooperative behaviour

Where this trial is running

Hyderabad, Telangana

• Asian Institute of Gastroenterology — Hyderabad, Telangana, India (Recruiting)

Study contacts

• Study coordinator: Partha Pal, MD, DNB, MRCP (UK), FASGE

Conditions Inflammatory Bowel Disease; Ultrasound; Inflammatory bowel disease; Crohn' s disease; Ulcerative colitis