Impact of Hepatitis B Virus on Inflammatory Bowel Disease

Recruiting

• Conditions: Inflammatory Bowel Disease (IBD); Hepatitis B Virus

• Registration Number: NCT06881238
• Lead Sponsor: Tanta University

Brief Summary

The goal of this observational retrospective study is to assess the impact of hepatitis B virus (HBV) infection on the clinical course and outcomes of inflammatory bowel disease (IBD) in Egyptian patients.

Researchers will compare the IBD extent, location, severity, and behavior between IBD patients with and without HBV infection.

Participants will be subjected to history-taking (history of hospital admission and disease flare, surgical history, medication history, follow-up duration, and mortality), clinical examination, laboratory investigations, abdominal ultrasonography, and endoscopic examination.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• Male or female patients older than 18 years.
• Patients with IBD are diagnosed by clinical, radiological, endoscopic, and histological criteria.

Exclusion Criteria

• Patients aged < 18 years
• Unwilling to participate in our study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with severe IBD measured by Truelove-Witts severity index	through study completion, an average of 6 month	comparing IBD extent, location, and behavior using Montreal classification, Truelove-Witts severity index between patients with and without HBV infection
Hospital admission rates in IBD patients	through study completion, an average of 6 month	comparing IBD hospital admission rates between patients with and without HBV infection
number of IBD patients undergoing surgical treatment	through study completion, an average of 6 month	comparing surgical treatment rates (intestinal resection in CD patients and total proctocolectomy in UC patients) for IBD between patients with and without HBV infection

Secondary Outcome Measures

Name	Time	Method
Disease flares rates in IBD patients	through study completion, an average of 6 months	comparing IBD disease flare rate between patients with and without HBV infection.
mortality rates in IBD patients	through study completion, an average of 6 months	comparing IBD mortality rates between patients with and without HBV infection.

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Gharbyea, Egypt