Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534216
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Role of Intestinal Ultrasound in Treat to Target Strategy in the Management of Inflammatory Bowel Disease the IUS-TTT Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Role of Intestinal Ultrasound in Treat to Target Strategy in the Management of Inflammatory Bowel Disease the IUS-TTT Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IUS-TTT
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 Crohns disease
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 Crohns Disease SES-CD 3 for Crohns disease will be enrolled Exclusion criteria include age 18 years Crohns 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 Crohns 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None