An interventional study of Intestinal ultrasound (IUS) and Standard of care in Inflammatory Bowel Diseases, Crohn Disease and Colitis, Ulcerative, sponsored by Mahidol University. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Mahidol University · Not applicable, Interventional, and Health services research
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.
This is a single-center randomized controlled trial conducted at the IBD Clinic, Faculty of Medicine Siriraj Hospital, Mahidol University.
Adult patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) who are undergoing endoscopy for assessment of disease severity are randomized 1:1, using computer-generated block-of-four randomization, to either standard of care plus intestinal ultrasound (IUS) or standard of care alone. Participants are followed for 48 weeks.
Follow-up visits are scheduled every 2 months for participants with active disease (Mayo endoscopic score of 2 or higher, or SES-CD of 3 or higher) and every 4 months for participants in remission.
In the IUS arm, intestinal ultrasound is performed at every visit by physicians certified by the International Bowel Ultrasound Group (IBUS). The physician performing the ultrasound is blinded to the blood and stool test results obtained on the same day. Measured parameters include bowel wall thickness (BWT), color Doppler signal, and mesenteric fat hypertrophy.
Standard of care in both arms 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.
The primary outcome is the proportion of participants with a change in treatment during the 48-week follow-up period.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
This study's planned enrollment of 137 is above the median of 68 across 870 interventional studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
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Exclusion Criteria:
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
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
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 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.
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.
Time frame: 48 weeks
Correlation between intestinal ultrasound parameters and endoscopic scores
Correlation between intestinal ultrasound parameters (bowel wall thickness, color Doppler signal, IBUS-SAS) and endoscopic scores (Mayo endoscopic score, SES-CD).
Time frame: 48 weeks
Time from first assessment to first treatment change
Time from the first study assessment to the first change in treatment, analyzed using the Kaplan-Meier method.
Time frame: 48 weeks
Proportion of participants with corticosteroid-free clinical remission
Time frame: 48 weeks
Proportion of participants with mucosal healing
Assessed only in participants who undergo follow-up colonoscopy, using Mayo endoscopic score 0-1 for ulcerative colitis or Simple Endoscopic Score for Crohn's Disease (SES-CD) 0-2 for Crohn's disease
Time frame: 48 weeks
Patient satisfaction with intestinal ultrasound
Assessed by a questionnaire administered after every intestinal ultrasound examination, using 5-point rating scales for 12 items.
Time frame: 48 weeks
Quality of life measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time frame: Week 0 and week 42
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Feb 2028, 23 months after the start.
Of 282 non-industry interventional studies with no phase under Inflammatory Bowel Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 50. This study's planned 23 months is below that.
Counting every sponsor, half of 296 studies reached it within 27 months; a quarter within 14 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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