Impact of Hepatitis B Virus on Inflammatory Bowel Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTanta University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patients older than 18 years.
Patients with IBD are diagnosed by clinical, radiological, endoscopic, and histological criteria.
Disqualifiers
Patients aged < 18 years
Unwilling to participate in our study
Trial population
IBD patients attending the Tanta Tropical Medicine Department, Faculty of Medicine.
Trial design
Design model
Ecologic or community
Time perspective
Retrospective
Treatments tested in this trial
History of IBD course and outcome in HBV patients
Other interventionFull 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)).
Treatment groups
162 Participants
are divided into 2 treatment groupsGroup A: IBD patients with positive HBV infection.1 intervention
Group B: IBD Patients with negative HBV infection1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
through study completion, an average of 6 month2
Hospital admission rates in IBD patients
comparing IBD hospital admission rates between patients with and without HBV infection
Time frame
through study completion, an average of 6 month3
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
Time frame
through study completion, an average of 6 monthSecondary outcomes
1
Disease flares rates in IBD patients
comparing IBD disease flare rate between patients with and without HBV infection.
Time frame
through study completion, an average of 6 months2
mortality rates in IBD patients
comparing IBD mortality rates between patients with and without HBV infection.
Time frame
through study completion, an average of 6 monthsSponsors and contacts
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Source ClinicalTrials.gov