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

NCT06534216 | Active Not Recruiting

• 1 other identifier: Post BH & R 57/03.2024-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Change in management

  Change in management after intestinal ultrasound as compared to standard of care at different time points (3, 6 and 12 months)

  12 months

Secondary Outcomes (5)

• Prediction of clinical and biomarker response

  3 months

• Prediction of clinical and biomarker remission

  6 months

• Prediction of transmural response

  12 months

• Prediction of transmural remission

  12 months

• Prediction of endoscopic response and remission

  12 months

Study Arms (1)

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

Interventions

Intestinal ultrasound DIAGNOSTIC_TEST

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.

Inflammatory bowel disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: April 5, 2024
• Primary Completion: March 4, 2026
• Study Completion: March 4, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)