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



Status:Active, not recruiting
Conditions:Irritable Bowel Syndrome (IBS), Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:6 - 23
Updated:7/20/2017
Start Date:July 2014
End Date:May 2018

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.

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.

Inclusion Criteria:

- Age 6-23 years

- Initiating Infliximab therapy

- Crohns disease involving the distal small bowel +/- proximal colon

- Willingness to undergo SBUS and fecal calprotectin collection prior to starting
infliximab and again at week 14 and week 54

- Able to give consent by patient and/or legal guardian

Exclusion Criteria:

- Ulcerative colitis or non-Crohn's Disease patients

- Lack of small bowel disease

- Patients started on alternative therapy

- Unable or unwilling to provide consent
We found this trial at
1
site
Cedars-Sinai Medical Center
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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