Intestinal Ultrasound in Pediatric Inflammatory Bowel Disease

NCT03026582 | Completed DMC

• 1 other identifier: SchneiderCMCIsrael
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Change in bowel wall thickness according to therapeutic regimen

  Two years

Secondary Outcomes (4)

• Change in bowel wall thickness in comparison to inflammatory markers

  Two years

• Change in bowel wall thickness in comparison to fecal calprotectin

  Two years

• Change in bowel wall thickness in comparison to pediatric Crohn's disease severity index in Crohn's disease

  Two years

• Change in bowel wall thickness in comparison to pediatric ulcerative colitis activity index in ulcerative colitis

  Two years

Interventions

Intestinal ultra-sound monitoring DEVICE

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.

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Diagnosis of IBD
• Age: 2- 17 years (inclusive)
• Informed consent

You may not qualify if:

• Pregnancy
• Morbid obesity

Sponsors & Collaborators

• Schneider Children's Medical Center, Israel: lead

Study Sites (1)

Schenider Children's Medical Center

Petah Tikva, 4920235, Israel

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Amit Assa

  Schneider Children's Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of IBD program

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 20, 2017
• Study Start: July 1, 2017
• Primary Completion: September 1, 2021
• Study Completion: September 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)