Impact of Hepatitis B Virus on Inflammatory Bowel Disease

March 11, 2025 updated by: Rania Mamdouh Elkafoury, Tanta University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Gharbyea
      • Tanta, Gharbyea, Egypt, 31516
        • Recruiting
        • Tanta University Hospitals
        • Contact:
        • Contact:
          • Amal M Dwidar, MD
        • Contact:
          • Rania M Elkafoury, MD
        • Contact:
          • Nabila A Elgazzar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

IBD patients attending the Tanta Tropical Medicine Department, Faculty of Medicine.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IBD patients with positive HBV infection.
81 IBD patients with positive HBV infection.
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 of laboratory investigations (complete blood picture, HBV serology, liver and kidney function tests, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP)).
IBD Patients with negative HBV infection
81 IBD Patients with negative HBV infection
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 of laboratory investigations (complete blood picture, HBV serology, liver and kidney function tests, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with severe IBD measured by Truelove-Witts severity index
Time Frame: 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
through study completion, an average of 6 month
Hospital admission rates in IBD patients
Time Frame: through study completion, an average of 6 month
comparing IBD hospital admission rates between patients with and without HBV infection
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
comparing surgical treatment rates (intestinal resection in CD patients and total proctocolectomy in UC patients) for IBD between patients with and without HBV infection
through study completion, an average of 6 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Study Director: Nabila A Elgazzar, MD, Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

June 10, 2025

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR979/12/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammatory Bowel Disease (IBD)

Clinical Trials on History of IBD course and outcome in HBV patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe