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Intestinal Ultrasound in Pediatric Inflammatory Bowel Disease (SPIBDUS)

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ClinicalTrials.gov Identifier: NCT03026582
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Amit Assa, Schneider Children's Medical Center, Israel

Brief Summary:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Change in bowel wall thickness according to therapeutic regimen [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Change in bowel wall thickness in comparison to inflammatory markers [ Time Frame: Two years ]
  2. Change in bowel wall thickness in comparison to fecal calprotectin [ Time Frame: Two years ]
  3. Change in bowel wall thickness in comparison to pediatric Crohn's disease severity index in Crohn's disease [ Time Frame: Two years ]
  4. Change in bowel wall thickness in comparison to pediatric ulcerative colitis activity index in ulcerative colitis [ Time Frame: Two years ]


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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children 2 years to 17 years who have been diagnosed at the Schneider Children's Hospital with either Crohn's disease or ulcerative colitis.
Criteria

Inclusion Criteria:

  1. Diagnosis of IBD
  2. Age: 2- 17 years (inclusive)
  3. Informed consent

Exclusion Criteria:

  1. Pregnancy
  2. Morbid obesity

Information from the National Library of Medicine

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


Contacts
Contact: Amit Assa, MD 972543522211 dr.amit.assa@gmail.com

Locations
Israel
Schenider Children's Medical Center Recruiting
Petaẖ Tiqwa, Israel, 4920235
Contact: Amit Assa, MD    972543522211    dr.amit.assa@gmail.com   
Sponsors and Collaborators
Schneider Children's Medical Center, Israel
Investigators
Principal Investigator: Amit Assa Schneider Children's Medical Center, Israel

Responsible Party: Amit Assa, Head of IBD program, Schneider Children's Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03026582     History of Changes
Other Study ID Numbers: SchneiderCMCIsrael
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis