Epidemiological Evaluation Of Chronic Kidney Disease In Pediatric Patients With Inflammatory Bowel Disease (KIBD)
A Multicenter, Cross-sectional Observational Study for the Epidemiological Evaluation of Chronic Kidney Disease in Pediatric Patients With Inflammatory Bowel Disease, and Its Relationship With Disease Activity and Medical Therapy.
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Clinical Trial Center (CTC) Clinical Trial Center (CTC)
- Numéro de téléphone: 0131206893
- E-mail: clinicaltrialcenter@ospedale.al.it
Lieux d'étude
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Piedmont
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Alessandria, Piedmont, Italie, 15121
- Recrutement
- Pediatric Unit
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Contact:
- Clinical Trial Center (CTC)
- Numéro de téléphone: 0131206893
- E-mail: clinicaltrialcenter@ospedale.al.it
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- 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
- Written informed consent from parent or legal guardian, and assent from the minor when applicable
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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IBD Patients
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.
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Control Group
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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Prevalence of Chronic Kidney Disease in Pediatric IBD Patients
Délai: At study enrollment (cross-sectional assessment)
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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.
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At study enrollment (cross-sectional assessment)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Association Between Disease Activity and Chronic Kidney Disease
Délai: At study enrollment (cross-sectional assessment)
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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.
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At study enrollment (cross-sectional assessment)
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ASO.Ped.25.06
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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