Impact of Hepatitis B Virus on Inflammatory Bowel Disease

NCT06881238 | Recruiting

• 1 other identifier: 36264PR979/12/24
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease (IBD); Hepatitis B Virus

Keywords

Hepatitis b virus; Inflammatory bowel disease course

Outcome Measures

Primary Outcomes (3)

• Number of patients with severe IBD measured by Truelove-Witts severity index

  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

  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

  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 Outcomes (2)

• Disease flares rates in IBD patients

  through study completion, an average of 6 months

• mortality rates in IBD patients

  through study completion, an average of 6 months

Study Arms (2)

IBD patients with positive HBV infection.

81 IBD patients with positive HBV infection.

Other: History of IBD course and outcome in HBV patients

IBD Patients with negative HBV infection

81 IBD Patients with negative HBV infection

Other: History of IBD course and outcome in HBV patients

Interventions

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)).

IBD Patients with negative HBV infection; IBD patients with positive HBV infection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Hepatitis B

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases

Study Officials

• Nabila A Elgazzar, MD

  Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

  STUDY DIRECTOR

Central Study Contacts

Rania M Elkafoury, MD

CONTACT

+201004672358; rania.elkafoury@med.tanta.edu.eg

Nabila A Elgazzar, MD

CONTACT

00201288585733; nabilaelgazzar@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Tropical Medicine

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 18, 2025
• Study Start: December 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 10, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

EG (1)