Intestinal Ultrasound Guided Management in Inflammatory Bowel Disease

NCT07775352 | Recruiting

• 1 other identifier: SI 272/2026
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

intestinal ultrasound; IBD; point-of-care ultrasound; treat-to-target; bowel wall thickness; IBUS-SAS

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with a change in treatment

  A change in treatment is defined as starting or stopping a medication, increasing or decreasing the dose of an existing medication, switching to a different drug class, surgery, or hospitalization due to disease flare.

  48 weeks

Secondary Outcomes (6)

• Correlation between intestinal ultrasound parameters and endoscopic scores

  48 weeks

• Time from first assessment to first treatment change

  48 weeks

• Proportion of participants with corticosteroid-free clinical remission

  48 weeks

• Proportion of participants with mucosal healing

  48 weeks

• Patient satisfaction with intestinal ultrasound

  48 weeks

Study Arms (2)

Standard of care plus intestinal ultrasound

EXPERIMENTAL

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.

Diagnostic Test: Intestinal ultrasound (IUS); Other: Standard of care

Standard of care alone

ACTIVE COMPARATOR

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.

Other: Standard of care

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 plus intestinal ultrasound

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.

Standard of care alone; Standard of care plus intestinal ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of inflammatory bowel disease for more than 2 months
• Age 18 years or older
• Undergoing endoscopy at enrollment for assessment of disease severity

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Julajak Limsrivilai, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thanaboon Chaemsupaphan, MD

CONTACT

+66 86 896 4889; ping_tnt@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. Participants and treating physicians are not masked. The physician performing the intestinal ultrasound is blinded to the blood and stool test results obtained on the same day.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are randomly assigned 1:1 to standard of care plus intestinal ultrasound or standard of care alone, using computer-generated block-of-four randomization.

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: August 20, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)