Renal Involvement in Adult Patients with Inflammatory Bowel Disease and Its Relation to Duration and Disease Activity

Not yet recruiting

• Conditions: IBD and Renal Involement; IBD Activity and Kidney Affection

• Registration Number: NCT06717516
• Lead Sponsor: Assiut University

Brief Summary

To Assess the pattern of renal injury in patients with inflammatory bowel disease and its relation to the duration and disease activity by Identification and characterization of early renal manifestations (e.g., proteinuria, hematuria, electrolyte imbalances) in IBD patients. and know Correlation between kidney involvement and IBD severity, including flare-ups and complications.

and know Impact of early renal manifestations on long-term renal outcomes, such as progression to CKD or development of AKI.

Detailed Description

Inflammatory bowel disease (IBD), comprising ulcerative colitis (UC) and Crohn's disease (CD), is a chronic immunemediated disorder of the gastro-intestinal tract characterized by recurrent inflammation and epithelial injury of the intestine. Extraintestinal manifestations are seen in 6% to 47% of patients diagnosed with IBD. Renal and urinary tract involvement occurs in 4% to 23% of patients with IBD, with renal calculi being the most common form of renal involvement. IBD is associated with a range of renal manifestations, including nephrolithiasis, glomerulonephritis, tubulointerstitial nephritis, and secondary amyloidosis, which can lead to acute or chronic renal insufficiency. Several potential mechanisms might contribute to the higher risk of incident CKD and AKI in patients with IBD. First, in the context of IBD, acute or chronic loss of circulating volume (salt and water depletion) due to persistent inflammation of the intestine and repeated intestinal resection could lead to electrolyte abnormalities followed by acute and chronic loss of kidney function, which may not be always reversible. Second, dysbiosis in patients with IBD is associated with increased production of microbiota-derived uremic toxins and microinflammation, both of which promote the progression of renal diseases. Third, IBD-related alterations in the innate and adaptive immune systems may lead to elevated proinflammatory cytokines, which are particularly implicated in the progression of renal disease. Understanding these associations is crucial for management and monitoring of IBD patients, particularly for those who may develop renal complications, so mitigating impact on kidney function and overall health.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-30
• Study First Submitted QC: 2024-11-30
• Last Update Submitted: 2024-11-30
• Study Start: 2024-12-01
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adults aged 18 years or older
• Confirmed diagnosis of IBD either crohns disease or ulcerative colities based on clinical ,endoscopic ,histological and radiological findings . - Patients in any stage of IBD, including remission, active disease, and flare-ups. - Willingness to participate and provide informed consent. - Renal Assessment for participants.

Exclusion Criteria

• Pre-existing chronic kidney disease (CKD) at any stage. - Known primary kidney diseases unrelated to IBD. - Current use of nephrotoxic medications not related to IBD treatment. - Pregnancy or breastfeeding. - Patients who are unable to comply with study protocols or follow-up assessment - Presence of other significant comorbidities that impact renal function or overall health

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of renal manifestations in IBD patients and Correlation between kidney involvement and IBD severity, including flare-ups and complications and its Impact on long-term renal outcomes, such as progression to CKD or development of AKI	scheduled follow-ups at 3,6,12 months	Identification and characterization of renal manifestations (e.g., proteinuria, hematuria, electrolyte imbalances) in IBD patients and Correlation between kidney involvement and IBD severity, including flare-ups and complications and Impact of early renal manifestations on long-term renal outcomes, such as progression to CKD or development of AKI