Hemorrhagic Proctocolitis Clinical Trials

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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.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Italy
Pediatric Unit
RECRUITING
Alessandria
Contact Information
Primary
Clinical Trial Center (CTC) Clinical Trial Center (CTC)
clinicaltrialcenter@ospedale.al.it
0131206893
Time Frame
Start Date: 2026-09-01
Estimated Completion Date: 2027-01
Participants
Target number of participants: 600
Treatments
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.
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.
Sponsors
Leads: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

This content was sourced from clinicaltrials.gov