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NCT Number: NCT06881238

Impact of Hepatitis B Virus on Inflammatory Bowel Disease

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.

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Key information

Conditions

Inflammatory Bowel Disease (IBD) Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B Virus Hepatitis, Viral, Human Infections Inflammatory Bowel Diseases Intestinal Diseases Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

Location status: Recruiting

Location contact

Amal M Dwidar, MD

SUB_INVESTIGATOR

Dina H Ziada, MD

CONTACT

[email protected]

00201117109990

Nabila A Elgazzar, MD

PRINCIPAL_INVESTIGATOR

Rania M Elkafoury, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

History of IBD course and outcome in HBV patients

Other

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)).

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nabila A Elgazzar, MD

CONTACT

[email protected]

00201288585733

Rania M Elkafoury, MD

CONTACT

[email protected]

+201004672358

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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