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Clinical Trials in India / NCT06534216
Active, not recruiting Observational

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

NCT06534216 · tracked via the Priya Life Science India tracker
Sponsor
Asian Institute of Gastroenterology, India
Phase
Observational
Started
2024-04-05
Last updated
2025-07-17

Condition(s) studied

Crohn DiseaseUlcerative Colitis

Investigational drug(s) / intervention(s)

Intestinal ultrasound

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Asian Institute of Gastroenterology Hyderabad Telangana

More Asian Institute of Gastroenterology, India trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06534216 on ClinicalTrials.gov ↗ ← All trials in India