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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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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

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Inflammatory Bowel Disease Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No