NCT02330458

The Role of Small Bowel Ultrasound in Initiation of Infliximab in Crohn's Disease Patients

The Role of Small Bowel Ultrasound After Ileocolic Resection or When Starting Infliximab in Crohn's Disease Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 6 Years – 23 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Disease
• Crohn's Disease

Interventions

Type	Name	Description
PROCEDURE	Small bowel ultrasound	Small Bowel Ultrasound will be performed by a single radiologist using an Acuson S2000 machine with 6 MHz convex and 9 MHz linear array transducers (Siemens, Germany). Participants will be asked to not eat for at least 8 hours prior to the ultrasound, and to drink 500ml of a fluid of their choice just prior to the SBUS, for bowel distension and better visualization. Bowel wall thickness (BWT), the length of any segment of thickened bowel wall \>3mm, hyperemia using doppler, and the presence of free fluid, stricture, intestinal dilation, or enlarged lymph nodes will be documented

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-05-01
• Completion: 2018-05-01
• First posted: 2015-01-05
• Last updated: 2017-07-19

Locations

1 site across 1 country: United States