Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2026-02-22 @ 7:25 AM
Study NCT ID:
NCT02330458
Status:
UNKNOWN
Last Update Posted:
2017-07-19
First Post:
2014-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Small Bowel Ultrasound in Initiation of Infliximab in Crohn's Disease Patients
Sponsor:
Cedars-Sinai Medical Center
Organization:
Study Overview
Official Title:
The Role of Small Bowel Ultrasound After Ileocolic Resection or When Starting Infliximab in Crohn's Disease Patients
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Goal is to prospectively determine if stool calprotectin and change in bowel wall thickness and hyperemia, as seen on small bowel ultrasound, at week 0, 14, and 54 can be used to predict response at week 54 to infliximab in pediatric patients with small bowel Crohn's Disease.
Detailed Description:
We will examine whether non-invasive disease monitoring tools such as bowel wall thickness as measured by small bowel ultrasound (SBUS) and mucosal inflammation as measured by fecal calprotectin, are independently associated with infliximab durability.
Study Oversight
Has Oversight DMC:
False
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?: