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Intestinal Ultrasound Guided Management in Inflammatory Bowel Disease

ConditionsInflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMahidol University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of inflammatory bowel disease for more than 2 months

Age 18 years or older

Undergoing endoscopy at enrollment for assessment of disease severity

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

    Other intervention

    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.

Treatment groups

137 Participants
are divided into 2 treatment groups
Group A: Standard of care plus intestinal ultrasoundExperimental treatment 2 interventions
Group B: Standard of care aloneActive comparator 1 intervention

Trial outcomes

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.

Time frame
48 weeks

Secondary outcomes

1

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
2

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
3

Proportion of participants with corticosteroid-free clinical remission

Time frame
48 weeks
4

Proportion of participants with mucosal healing

Assessed only in participants who undergo follow-up colonoscopy.

Time frame
48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mahidol University

Lead sponsor

Source ClinicalTrials.gov
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