Crohn's Disease, Inflammatory Bowel Disease
Conditions
Keywords
Inflammatory Bowel Disease, Crohn's disease, Pediatric IBD, small bowel ultrasound, infliximab
Brief 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.
Interventions
PROCEDURESmall 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
Sponsors
Cedars-Sinai Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 23 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in bowel wall thickness on small bowel ultrasound (SBUS) | 1 year | Change in bowel wall thickness as measured on small bowel ultrasound from ultrasound performed on week 0 to ultrasound performed at week 54. 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. Univariate analyses will be performed to determine the association between bowel wall thickness on SBUS, and delta BWT (change in bowel wall thickness week 0 to week 14) and presence of remission at week 54 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in stool calprotectin | 1 year | Change in level of stool calprotectin (lab) between week 0 and week 54. Stool will be collected within 24 hours of infusion and performed at our outpatient lab and analyzed by ELISA. Univariate analyses will be performed to determine the association between calprotectin level, delta calprotectin level (change in calprotectin level week 0 to week 14) and presence of remission at week 54. |
Countries
United States
Outcome results
None listed