Role of Intestinal Ultrasound in Treat to Target Strategy in the Management of Inflammatory Bowel Disease : the IUS-TTT Study (IUS-TTT)

July 14, 2025 updated by: Asian Institute of Gastroenterology, India
This study aims to evaluate the role of bedside Intestinal Ultrasound (IUS) as a cost-effective, non-invasive, and well-tolerated procedure within the Treat-to-Target strategy for managing Inflammatory Bowel Disease (IBD). Despite its growing use, therapeutic targets for IUS-guided treatment remain inadequately defined. The study will investigate the feasibility of IUS in monitoring transmural response and remission, and its potential to predict clinical and biochemical responses at 3 months, as well as mucosal healing at 6 and 12 months. By incorporating IUS into routine clinical care, we aim to enhance disease management and optimize therapeutic outcomes for patients with ulcerative colitis and Crohn's disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective observational pilot study aims to assess the role of Intestinal Ultrasound (IUS) in the management of active Inflammatory Bowel Disease (IBD) over a 6-12 month period at a single tertiary center. The primary objective is to determine the incidence of transmural response at short-term and transmural remission at long-term follow-up. Secondary objectives include evaluating the predictive role of IUS performed at weeks 2-6 for clinical and biochemical response at 3 months, and as a predictor of mucosal healing at 6-12 months. Adult patients with active IBD, defined by endoscopic criteria (Ulcerative Colitis Endoscopic Index of Severity [UCEIS] ≥ 2 for ulcerative colitis and Simple Endoscopic Score for Crohn's Disease [SES-CD] ≥ 3 for Crohn's disease), will be enrolled. Exclusion criteria include age <18 years, Crohn's disease restricted to non-terminal ileum small bowel or gastroduodenal area, normal bowel wall thickness in all segments at week 0, isolated proctitis in ulcerative colitis, body mass index (BMI) >30, and pregnancy. Participants will undergo IUS at baseline, 2-6 weeks, 12 weeks, and 6-12 months, along with measurements of fecal calprotectin, C-reactive protein (CRP), Harvey-Bradshaw Index (HBI), and Simple Clinical Colitis Activity Index (SCCAI), and ileocolonoscopy at baseline and 6-12 months. IUS parameters will include bowel wall thickness, vascularization, wall stratification, mesentery features, and complications. The Milan Ultrasound Criteria (MUC) for ulcerative colitis and the Bowel Ultrasound Score (BUSS) and International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) for Crohn's disease will be used to assess disease activity. Outcomes will measure the incidence of transmural response and remission, and the predictive role of early IUS for clinical, biochemical, and mucosal healing. Ethical clearance is obtained, and informed consent will be taken from all participants. The study aims to enroll 100 patients to gather sufficient data for analysis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Asian Institute of Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study will include adult patients with active Inflammatory Bowel Disease (IBD), specifically those diagnosed with either Crohn's disease or ulcerative colitis. To be eligible for enrollment, patients must be over the age of 18 years and must provide informed consent. Active Crohn's disease will be defined as having a Simple Endoscopic Score for Crohn's Disease (SES-CD) of 3 or higher, while active ulcerative colitis will be defined as having an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) of 2 or higher. Patients will be recruited from the Inflammatory Bowel Disease clinic or from inpatients admitted with active disease. Inclusion in the study will only proceed once informed consent has been obtained. This study aims to evaluate the role of intestinal ultrasound in monitoring and guiding the treatment of active IBD, focusing on its feasibility in assessing transmural response and remission as treatment targets.

Description

Inclusion Criteria:

  • Adults over the age of 18 years.
  • Active Crohn's disease, defined as a Simple Endoscopic Score for Crohn's Disease of 3 or higher.
  • Active ulcerative colitis, defined as an Ulcerative Colitis Endoscopic Index of Severity of 2 or higher.

Exclusion Criteria:

  • Age < 18 years
  • Intestinal ultrasound for assessment of response to therapy
  • Intestinal ultrasound for clinically asymptomatic disease
  • Pregnancy and lactating mothers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Inflammatory bowel disease
Adult patients with active Inflammatory Bowel Disease (IBD) are eligible for enrollment after obtaining informed consent. Active disease will be defined based on endoscopy with a Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of 2 or greater for ulcerative colitis, and a Simple Endoscopic Score for Crohn's Disease (SES-CD) of 3 or greater for Crohn's disease.
Diagnostic test: Intestinal ultrasound
This study employs intestinal ultrasound (IUS) to assess disease activity in Inflammatory Bowel Disease (IBD) patients. Ultrasound parameters include bowel wall thickness measurement, evaluation of vascularization via color Doppler, assessment of wall stratification, and identification of mesentery features and complications (e.g., strictures, fistulas, abscesses). For ulcerative colitis, disease activity is gauged using the Milan Ultrasound Criteria (MUC), where a score >6.3 indicates active disease based on bowel wall thickness and vascularization. In Crohn's disease, the Bowel Ultrasound Score (BUSS) and International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) assess bowel wall thickness, vascularization, stratification, and inflammatory fat, with scores >3.52 (BUSS) and >48.7 (IBUS-SAS) indicating active disease. IUS evaluations occur at baseline, 2-6 weeks, 12 weeks, and 6-12 months to track disease progression and treatment response.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in management
Time Frame: 12 months
Change in management after intestinal ultrasound as compared to standard of care at different time points (3, 6 and 12 months)
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prediction of clinical and biomarker response
Time Frame: 3 months
Prediction of clinical and biomarker response at 3 months by 2-6 weeks intestinal ultrasound
3 months
Prediction of clinical and biomarker remission
Time Frame: 6 months
Prediction of clinical and biomarker remission at 6 months by 2-6 weeks and 3 months intestinal ultrasound
6 months
Prediction of transmural response
Time Frame: 12 months
Prediction of transmural response at 3, 6 and 12 months by 2-6 weeks, 3 months and 6 months intestinal ultrasound
12 months
Prediction of transmural remission
Time Frame: 12 months
Prediction of transmural remission at 12 months by 2-6 weeks, 3 months and 6 months intestinal ultrasound
12 months
Prediction of endoscopic response and remission
Time Frame: 12 months
Prediction of endoscopic response and remission at 6-12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asian Institute of Gastroenterology, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 4, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 4, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Post BH & R 57/03.2024-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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