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Идёт набор NCT07670988

Epidemiological Evaluation Of Chronic Kidney Disease In Pediatric Patients With Inflammatory Bowel Disease

— Наблюдательное Inflammatory Bowel Diseases (IBD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Clinical and Laboratory Data Collection.
Кому может быть актуально
Состояния в реестре: Inflammatory Bowel Diseases (IBD). Базовые параметры: 2 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Prevalence of Chronic Kidney Disease in Pediatric IBD Patients [Срок оценки: At study enrollment (cross-sectional assessment)]
Вторичные конечные точки (1)
  • Association Between Disease Activity and Chronic Kidney Disease [Срок оценки: At study enrollment (cross-sectional assessment)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Италия · 1 центр
  • Pediatric Unit — Alessandria

Идентификаторы

NCT: NCT07670988 · ASO.Ped.25.06

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗