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Recruiting NCT06881238

Impact of Hepatitis B Virus on Inflammatory Bowel Disease

— Observational Inflammatory Bowel Disease (IBD) Hepatitis B Virus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: History of IBD course and outcome in HBV patients.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Disease (IBD), Hepatitis B Virus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other History 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

Primary outcome measures

  • Number of patients with severe IBD measured by Truelove-Witts severity index [Time frame: through study completion, an average of 6 month]
  • Hospital admission rates in IBD patients [Time frame: through study completion, an average of 6 month]
  • number of IBD patients undergoing surgical treatment [Time frame: through study completion, an average of 6 month]
Secondary outcome measures (2)
  • Disease flares rates in IBD patients [Time frame: through study completion, an average of 6 months]
  • mortality rates in IBD patients [Time frame: through study completion, an average of 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Ecologic or community

Study locations

Egypt · 1 center
  • Tanta University Hospitals — Tanta

Identifiers

NCT: NCT06881238 · 36264PR979/12/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗