Renal Manifestations of IBD

To detect whether patients with inflammarory bowel disease (IBD) have some degree of renal involvement and also to determine if associated with disease activity or not.

Study Overview

• Status: Unknown
• Conditions: Kidney Diseases

Detailed Description

Inflammatory bowel diseases (IBD) comprise two types of chronic intestinal disorders: Crohn's disease (CD) and ulcerative colitis (UC). CD involves the ileum and colon, but it can affect any region of the intestine, often discontinuously. UC involves the rectum and may affect part of the colon or the entire colon (pancolitis) in an un interrupted pattern. In Crohn's, the inflammation is often transmural, whereas in Ulcerative colitis the inflammation is typically confined to the mucosa . The extraintestinal manifestations of IBD are common and may occur in 25%-40% of patients. Inflammatory manifestations in the skin, eyes, liver and joints are considered primary manifestations. Development of primary extra intestinal manifestation appears to increase the risk of developing a second extra intestinal manifestation. Most IBD patients with extra intestinal manifestations have colonic inflammation, although some patients develop them prior to the onset of colonic symptoms. Extra intestinal manifestations are usually present at the time of active phase of IBD . In recent years, there have been reports on renal and urologic complications of IBD. They were mostly found to be related to ureteral obstruction by oxalate stones, cystitis, acute tubular necrosis due to volume depletion and AA amyloidosis. Nephrolithiasis and obstructive uropathy are especially seen with small bowel dysfunction. In a great proportion of IBD patients, ureteral obstruction is not caused by stones. This non calculus obstruction can occur in 50%-73% of CD patients and 50% of UC patients, and is usually caused by retroperitoneal local inflammation or by surgical complication (sutures) or colon cancer . There have also been reports of interstitial nephritis, mainly due to applied anti-inflammatory therapy, such as 5-aminosalicylic acid (5-ASA). Serious renal impairment is reported to occur in 1 of 500 patients treated with 5-ASA derivative. On the other hand, there are some reports that renal tubular damage is an extra intestinal manifestation of IBD and not a toxic side effect of anti-inflammatory therapy using 5-ASA or sulfasalazine. Furthermore, renal failure due to glomerulonephritis (GN) caused by the immune complex has been reported in several cases as an extraintestinal manifestation of IBD.

• Study Type: Observational
• Enrollment (Anticipated): 194

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 11117
    • Recruiting
    • Egypt
    • Contact: Fayza Kamel Abdelkalek, Resident; Phone Number: 002 01060564991

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients with IBD without any of exclusion criteria will be enrolled in the study

Description

Inclusion Criteria:

- A ny patients with IBD

Exclusion Criteria:

Pregnant kidney disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal manifestations of IBD	Access renal manifestations of IBD	12 month

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Ambruzs JM, Larsen CP. Renal Manifestations of Inflammatory Bowel Disease. Rheum Dis Clin North Am. 2018 Nov;44(4):699-714. doi: 10.1016/j.rdc.2018.06.007. Epub 2018 Sep 7.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: Renal manifestations of IBD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No