Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
Conditions
Keywords
intestinal ultrasound, IBD, point-of-care ultrasound, treat-to-target, bowel wall thickness, IBUS-SAS
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTIntestinal 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.
OTHERStandard 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
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of inflammatory bowel disease for more than 2 months * Age 18 years or older * Undergoing endoscopy at enrollment for assessment of disease severity
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with a change in treatment | 48 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between intestinal ultrasound parameters and endoscopic scores | 48 weeks | Correlation between intestinal ultrasound parameters (bowel wall thickness, color Doppler signal, IBUS-SAS) and endoscopic scores (Mayo endoscopic score, SES-CD). |
| Time from first assessment to first treatment change | 48 weeks | Time from the first study assessment to the first change in treatment, analyzed using the Kaplan-Meier method. |
| Proportion of participants with corticosteroid-free clinical remission | 48 weeks | — |
| Proportion of participants with mucosal healing | 48 weeks | Assessed only in participants who undergo follow-up colonoscopy. |
| Patient satisfaction with intestinal ultrasound | 48 weeks | Assessed by a questionnaire administered after every intestinal ultrasound examination. |
| Quality of life measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | Week 0 and week 42 | — |
Countries
Thailand
Contacts
CONTACTThanaboon Chaemsupaphan, MD
PRINCIPAL_INVESTIGATORJulajak Limsrivilai, MD
Mahidol University
Outcome results
None listed