About this trial
This multicenter observational cross-sectional study aims to evaluate the prevalence of chronic kidney disease (CKD) in pediatric patients with inflammatory bowel disease (IBD) and to compare it with a control group without IBD.
Inflammatory bowel diseases, including Crohn's disease and ulcerative colitis, are chronic conditions that can also affect organs outside the intestine. Among these, kidney involvement has been reported, but data in pediatric populations are limited.
The study will collect clinical, laboratory, and demographic data from pediatric patients with IBD and matched controls without IBD. The main objective is to estimate the prevalence of CKD in children with IBD and compare it with that observed in the control group. Secondary objectives include describing patient characteristics and exploring potential associations between CKD, disease activity, and medical therapies.
The results of this study may improve the understanding of kidney complications in pediatric IBD and support earlier diagnosis and better clinical management.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pediatric patients aged between 2 and 17 years
For the case group: confirmed diagnosis of inflammatory bowel disease according to Porto criteria
For the control group: absence of current or previous diagnosis of inflammatory bowel disease
Availability of clinical and laboratory data required for study evaluation
Disqualifiers
History of pre-existing renal disease (congenital or acquired before IBD diagnosis)
Presence of conditions that may affect renal function (e.g., diabetes mellitus, hypertension, chronic use of nephrotoxic drugs)
Lack of informed consent
Trial population
Pediatric patients aged 2 to 17 years recruited from participating centers, including patients with inflammatory bowel disease and a matched control group without IBD.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Clinical and Laboratory Data Collection
Other interventionCollection of anonymized clinical, demographic, laboratory, and therapeutic data from pediatric patients with inflammatory bowel disease (IBD) and matched controls. Data are collected through review of medical records and routine clinical assessments, including renal function evaluation (eGFR, creatinine, albuminuria), disease activity indices, and treatment history. No experimental intervention or modification of standard clinical practice is performed.
Treatment groups
Trial outcomes
Primary outcomes
Prevalence of Chronic Kidney Disease in Pediatric IBD Patients
Prevalence of patient with chronic kidney disease, compared with a matched control group without inflammatory bowel disease. Chronic kidney disease will be defined using estimated glomerular filtration rate (eGFR) calculated with the Schwartz formula and/or presence of albuminuria.
Secondary outcomes
Association Between Disease Activity and Chronic Kidney Disease
Assessment of the association between disease activity indices (e.g., PUCAI, PCDAI), laboratory parameters, and the presence of chronic kidney disease in pediatric patients with inflammatory bowel disease.
Sponsors and contacts
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