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Intestinal Ultrasound in Pediatric Inflammatory Bowel Disease

NCT03026582 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-11-22

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases

Interventions

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.

Sponsors & Collaborators

  • Schneider Children's Medical Center, Israel

    lead OTHER

Principal Investigators

  • Amit Assa · Schneider Children's Medical Center, Israel

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2021-09-01
Completion
2023-09-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03026582 on ClinicalTrials.gov