Inflammatory Bowel DiseasesNCT07775352
Intestinal Ultrasound Guided Management in Inflammatory Bowel Disease
A study testing Intestinal ultrasound (IUS) in people with Inflammatory Bowel Diseases and Crohn Disease, run by Mahidol University at 1 site in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
- What is being tested?
- Intestinal ultrasound (IUS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteThailand
- Study dates
- 25 Mar 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of inflammatory bowel disease for more than 2 months
- Age 18 years or older
- Undergoing endoscopy at enrollment for assessment of disease severity
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Thanaboon Chaemsupaphan, MD, +66 86 896 4889, ping_tnt@hotmail.com
About this study
Official title: A Randomized Controlled Trial Comparing Standard of Care With and Without Intestinal Ultrasound Guidance in Patients With Inflammatory Bowel Diseases
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.
Read the 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.
- Being tested
- Intestinal ultrasound (IUS), Standard of care
- Keywords
- intestinal ultrasound, IBD, point-of-care ultrasound, treat-to-target, bowel wall thickness, IBUS-SAS
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (6)
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).
Measured: 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.
Measured: 48 weeks
Proportion of participants with corticosteroid-free clinical remission
Measured: 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
Measured: 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.
Measured: 48 weeks
Quality of life measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Measured: Week 0 and week 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start25 Mar 2026
- Primary completionFeb 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julajak Limsrivilai, Mahidol University
- Investigators
- Julajak Limsrivilai, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775352
- Sponsor's protocol ID
- SI 272/2026
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Standard of Care With and Without Intestinal Ultrasound Guidance in Patients With Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT07775352
- Acronym / sponsor ID
- SI 272/2026
- Keywords
- intestinal ultrasound, IBD, point-of-care ultrasound, treat-to-target, bowel wall thickness, IBUS-SAS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of care plus intestinal ultrasound | Experimental | Diagnostic Test: Intestinal ultrasound (IUS), Other: Standard of careParticipants 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. |
| Standard of care alone | Active comparator | Other: Standard of careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of inflammatory bowel disease for more than 2 months
- Age 18 years or older
- Undergoing endoscopy at enrollment for assessment of disease severity
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal 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. | Diagnostic test | Standard of care plus intestinal ultrasound |
| Standard of careStandard 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. | Other | Standard of care alone, Standard of care plus intestinal ultrasound |
Primary outcome
Proportion of participants with a change in treatment
Time frame: 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.
6 secondary outcomes
Correlation between intestinal ultrasound parameters and endoscopic scores
Time frame: 48 weeks
Time from first assessment to first treatment change
Time frame: 48 weeks
Proportion of participants with corticosteroid-free clinical remission
Time frame: 48 weeks
Proportion of participants with mucosal healing
Time frame: 48 weeks
Patient satisfaction with intestinal ultrasound
Time frame: 48 weeks
Quality of life measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time frame: Week 0 and week 42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julajak Limsrivilai, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intestinal ultrasound (IUS) in people with Inflammatory Bowel Diseases and Crohn Disease, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thanaboon Chaemsupaphan, MD (+66 86 896 4889, ping_tnt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a change in treatment (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.