An observational study in Inflammatory Bowel Diseases (IBD), sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria. Recruiting at 1 site in Italy. Open to participants aged 2 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Observational
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.
Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic relapsing conditions that frequently begin during childhood or adolescence. In pediatric patients, IBD often presents with more severe disease phenotypes and may be associated with extraintestinal manifestations involving multiple organ systems.
Renal involvement is among the reported extraintestinal manifestations of IBD and includes a wide spectrum of conditions, such as nephrolithiasis, tubulointerstitial nephritis, glomerulonephritis, and chronic kidney disease (CKD). While these complications are relatively well described in adult populations, epidemiological data in pediatric patients remain limited, particularly in the Italian setting.
Understanding the prevalence of CKD and its potential associations with disease activity and medical therapy is essential to improve early detection and long-term outcomes in pediatric patients with IBD.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
This study's planned enrollment of 600 is above the median of 140 across 626 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria is the lead sponsor of 37 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pediatric patients aged 2 to 17 years recruited from participating centers, including patients with inflammatory bowel disease and a matched control group without IBD.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pediatric patients aged 2 to 17 years with a confirmed diagnosis of inflammatory bowel disease, including Crohn disease, ulcerative colitis, or unclassified IBD. Data are collected from medical records without any intervention.
Pediatric patients aged 2 to 17 years without a diagnosis of inflammatory bowel disease, matched by age, sex, and recruiting center. Data are collected from medical records without any intervention.
Other: Clinical and Laboratory Data Collection
Collection 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.
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.
Time frame: At study enrollment (cross-sectional assessment)
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.
Time frame: At study enrollment (cross-sectional assessment)
Plan to share: No
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Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria