Intestinal Ultrasound in Pediatric Inflammatory Bowel Disease (SPIBDUS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03026582|
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : July 5, 2017
Objectives: To assess the predictive value of IUS in children with IBD.
Design: A prospective longitudinal cohort study.
Setting: Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital.
Participants: Children 2 years to 17 years (up to 200 patients) who have been diagnosed with either CD or UC.
Main outcome measures: The changes in bowel wall thickness, assessed by IUS, during 2-year follow-up according to therapeutic regimen.
Secondary outcome measures: Correlation of sonographic measures to clinical disease indices, serum inflammatory and other laboratory markers, fecal calprotectin, endoscopic and other radiologic measures performed as part of routine care.
|Condition or disease||Intervention/treatment|
|Inflammatory Bowel Diseases||Device: Intestinal ultra-sound monitoring|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Intestinal Ultrasound Role in the Management of Pediatric Inflammatory Bowel Disease: A Prospective Longitudinal Cohort Study|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||June 2020|
- Device: Intestinal ultra-sound monitoring
Children diagnosed with either CD or UC will be enrolled at diagnosis or at any time point during follow-up. Patients' characteristics will be retrieved from their medical files including demographic details, disease phenotype, endoscopic and radiologic variables, anthropometric measures, laboratory evaluation, complication and therapeutic regimens. At enrollment and every 3 months for a total period of 2 years all patients will perform intestinal US during regular clinic visits. All other measures including laboratory exams, anthropometric measurements and disease activity indices (either PCDAI for CD or PUCAI for UC) will be performed as part of standard of care.
- Change in bowel wall thickness according to therapeutic regimen [ Time Frame: Two years ]
- Change in bowel wall thickness in comparison to inflammatory markers [ Time Frame: Two years ]
- Change in bowel wall thickness in comparison to fecal calprotectin [ Time Frame: Two years ]
- Change in bowel wall thickness in comparison to pediatric Crohn's disease severity index in Crohn's disease [ Time Frame: Two years ]
- Change in bowel wall thickness in comparison to pediatric ulcerative colitis activity index in ulcerative colitis [ Time Frame: Two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026582
|Contact: Amit Assa, MDemail@example.com|
|Schenider Children's Medical Center||Recruiting|
|Petaẖ Tiqwa, Israel, 4920235|
|Contact: Amit Assa, MD 972543522211 firstname.lastname@example.org|
|Principal Investigator:||Amit Assa||Schneider Children's Medical Center, Israel|