UnknownNot Applicable

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

United States20 participantsStarted 2014-07

Plain-language 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.

Who can participate

Age range6 Years – 23 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in bowel wall thickness on small bowel ultrasound (SBUS)

Timeframe: 1 year

Trial details

NCT IDNCT02330458

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-05

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