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Impact of Hepatitis B Virus on Inflammatory Bowel Disease

The Impact of Hepatitis B Virus Infection on the Clinical Course of Inflammatory Bowel Disease in Egyptian Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06881238
Enrollment
162
Registered
2025-03-18
Start date
2024-12-01
Completion date
2025-06-10
Last updated
2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Virus, Inflammatory Bowel Disease (IBD)

Keywords

Hepatitis b virus, Inflammatory bowel disease course

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.

Interventions

OTHERHistory of IBD course and outcome in HBV patients

Full history taking including: * Personal history (name, age, sex, occupation, residence, and marital state). * Complaint. * Age at diagnosis of IBD. * Medication history. * History of hospital admissions and disease flares. * Disease extent, location, and behavior. (Montreal classification, Truelove-Witts severity index). * Surgical history (intestinal resection in CD patients and total proctocolectomy in UC patients). * Follow up duration and mortality. * Data of endoscopic examination * Data of laboratory investigations (complete blood picture, HBV serology, liver and kidney function tests, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP)).

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Disease flares rates in IBD patientsthrough study completion, an average of 6 monthscomparing IBD disease flare rate between patients with and without HBV infection.
mortality rates in IBD patientsthrough study completion, an average of 6 monthscomparing IBD mortality rates between patients with and without HBV infection.

Countries

Egypt

Contacts

Primary ContactRania M Elkafoury, MD
rania.elkafoury@med.tanta.edu.eg+201004672358
Backup ContactNabila A Elgazzar, MD
nabilaelgazzar@med.tanta.edu.eg00201288585733

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026