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Recruiting NCT07520747

A Database Study of Disease, Treatment Patterns and Healthcare Use in Children With Inflammatory Bowel Diseases in Korea

— Observational Inflammatory Bowel Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Diseases. Basic parameters: up to 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Epidemiology, Treatment Patterns, and Healthcare Resource Utilization in Pediatric Patients Under 18 Years of Age With Inflammatory Bowel Diseases in Korea: A Claims Database Study

Overview

The purpose of this study is: * to find out out the number of children who develop crohn's disease (CD) and ulcerative colitis (UC) each year and are living with the disease and to see how this differs by age groups. * to understand how children of different age groups are treated over time and how their treatment changes as they grow. * to assess how often children use healthcare services and how much this costs for different age groups over several years. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system) and develop ulcers.

Primary outcome measures

  • Crude and Age-Adjusted Annual Incidence in Pediatric Crohn's Disease (CD) [Time frame: During the index period (2012 to 2023; up to 12 years)]
  • Crude and Age-Adjusted Annual Incidence in Pediatric Ulcerative Colitis (UC) [Time frame: During the index period (2012 to 2023; up to 12 years)]
  • Crude and Age-Adjusted Annual Prevalence in Pediatric CD [Time frame: During the index period (2012 to 2023; up to 12 years)]
  • Crude and Age-Adjusted Annual Prevalence in Pediatric UC [Time frame: During the index period (2012 to 2023; up to 12 years)]
  • Incidence of CD by Age-Stratified Groups [Time frame: During the index period (2012 to 2023; up to 12 years)]
  • Incidence of UC by Age-Stratified Groups [Time frame: During the index period (2012 to 2023; up to 12 years)]
  • Prevalence of CD by Age-Stratified Groups [Time frame: During the index period (2012 to 2023; up to 12 years)]
  • Prevalence of UC by Age-Stratified Groups [Time frame: During the index period (2012 to 2023; up to 12 years)]
  • Percentage of Participants Whose Primary Diagnosis Switched Between CD and UC [Time frame: During the index period (2012 to 2023; up to 12 years)]
  • Initial Treatment Types by Age-Stratified Group [Time frame: From index date to follow-up (Up to 13 years)]

Eligibility criteria

Inclusion criteria

  • Participants with at least two outpatient or one inpatient diagnosis codes for the same disease type (either CD or UC) using international classification of diseases, tenth revision (ICD-10) codes (K50. X for CD and K51. X for UC) recorded as primary or the first secondary diagnosis, and the codes for rare and intractable disease registration program (V130 for CD, V131 for UC) during the index period
  • Participants who received at least one prescription for conventional pediatric inflammatory bowel disease (IBD)-related medications (for example, 5-aminosalicylic acids \[5-ASAs\], exclusive enteral nutrition \[EENs\], corticosteroids, immunomodulators, or biologic drugs) during the index period

Exclusion criteria

\- No specific exclusion criteria are defined in this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Sungkyunkwan University Research and Business Foundation — Suwon

Identifiers

NCT: NCT07520747 · CNTO1275IBD4014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗