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

Cedars-Sinai Medical Center

Status: Unknown

Conditions: Inflammatory Bowel Disease; Crohn's Disease

Treatments: Procedure: Small bowel ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT02330458

Pro00027597

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 23 years old

Volunteers: No Healthy Volunteers

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