Clinical trial NCT02330458: The Role of Small Bowel Ultrasound in Initiation of Infliximab in Crohn's Disease Patients
Official title: The Role of Small Bowel Ultrasound After Ileocolic Resection or When Starting Infliximab in Crohn's Disease Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Keywords: Inflammatory Bowel Disease
Crohn's disease
Pediatric IBD
small bowel ultrasound
infliximab
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Crohn's disease involving the small bowel, initiating Infliximab treatment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in bowel wall thickness on small bowel ultrasound (SBUS)
timeFrame: 1 year
Secondary outcomes:
measure: Change in stool calprotectin
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Namita Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moscandrew ME, Loftus EV Jr. Diagnostic advances in inflammatory bowel disease (imaging and laboratory). Curr Gastroenterol Rep. 2009 Dec;11(6):488-95. doi: 10.1007/s11894-009-0074-7.
citation: Strobel D, Goertz RS, Bernatik T. Diagnostics in inflammatory bowel disease: ultrasound. World J Gastroenterol. 2011 Jul 21;17(27):3192-7. doi: 10.3748/wjg.v17.i27.3192.
citation: Allen PB, De Cruz P, Lee WK, Taylor S, Desmond PV, Kamm MA. Noninvasive imaging of the small bowel in Crohn's disease: the final frontier. Inflamm Bowel Dis. 2011 Sep;17(9):1987-99. doi: 10.1002/ibd.21598. Epub 2011 Feb 1.
citation: Fraquelli M, Colli A, Casazza G, Paggi S, Colucci A, Massironi S, Duca P, Conte D. Role of US in detection of Crohn disease: meta-analysis. Radiology. 2005 Jul;236(1):95-101. doi: 10.1148/radiol.2361040799.
citation: Parente F, Molteni M, Marino B, Colli A, Ardizzone S, Greco S, Sampietro G, Foschi D, Gallus S. Are colonoscopy and bowel ultrasound useful for assessing response to short-term therapy and predicting disease outcome of moderate-to-severe forms of ulcerative colitis?: a prospective study. Am J Gastroenterol. 2010 May;105(5):1150-7. doi: 10.1038/ajg.2009.672. Epub 2009 Dec 8.