Crohn's Disease Clinical Trial
Official title:
The Role of Small Bowel Ultrasound After Ileocolic Resection or When Starting Infliximab in Crohn's Disease Patients
Verified date | July 2017 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | May 2018 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 23 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
United States,
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. Review. — View 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. — View Citation
Moscandrew ME, Loftus EV Jr. Diagnostic advances in inflammatory bowel disease (imaging and laboratory). Curr Gastroenterol Rep. 2009 Dec;11(6):488-95. Review. — View 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. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in bowel wall thickness on small bowel ultrasound (SBUS) | 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 |
1 year | |
Secondary | Change in stool calprotectin | 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. |
1 year |
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