Inflammatory Bowel Disease (IBD)NCT06881238
Impact of Hepatitis B Virus on Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease (IBD) and Hepatitis B Virus, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Hepatitis B Virus
- What is being tested?
- History of IBD course and outcome in HBV patients
- How many people
- 162 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 10 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: IBD patients attending the Tanta Tropical Medicine Department, Faculty of Medicine.
Who may be able to join
- Male or female patients older than 18 years.
- Patients with IBD are diagnosed by clinical, radiological, endoscopic, and histological criteria.
Who cannot join
- Patients aged < 18 years
- Unwilling to participate in our study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Gharbyea, 31516
Dina H Ziada, MD, 00201117109990, dina.ziada@med.tanta.edu.eg
Nabila A Elgazzar, MD
About this study
Official title: 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.
- Being tested
- History of IBD course and outcome in HBV patients
- Keywords
- Hepatitis b virus, Inflammatory bowel disease course
- Medical subject headings
- Inflammatory Bowel Diseases, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
History of IBD course and outcome in HBV patientsOther
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)).
| Study group | Role | What they receive |
|---|---|---|
| IBD patients with positive HBV infection. | 81 IBD patients with positive HBV infection. Receives: Other: History of IBD course and outcome in HBV patients | |
| IBD Patients with negative HBV infection | 81 IBD Patients with negative HBV infection Receives: Other: History of IBD course and outcome in HBV patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: through study completion, an average of 6 month
Secondary outcomes (2)
Disease flares rates in IBD patients
comparing IBD disease flare rate between patients with and without HBV infection.
Measured: through study completion, an average of 6 months
mortality rates in IBD patients
comparing IBD mortality rates between patients with and without HBV infection.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Dec 2024
- Primary completion30 May 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mamdouh Elkafoury, Tanta University
- Investigators
- Nabila A Elgazzar, MD, Study director, Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881238
- Sponsor's protocol ID
- 36264PR979/12/24
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Hepatitis B Virus Infection on the Clinical Course of Inflammatory Bowel Disease in Egyptian Patients
- ClinicalTrials.gov ID
- NCT06881238
- Acronym / sponsor ID
- 36264PR979/12/24
- Keywords
- Hepatitis b virus, Inflammatory bowel disease course
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD patients with positive HBV infection. | – | Other: History of IBD course and outcome in HBV patients81 IBD patients with positive HBV infection. |
| IBD Patients with negative HBV infection | – | Other: History of IBD course and outcome in HBV patients81 IBD Patients with negative HBV infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- IBD patients attending the Tanta Tropical Medicine Department, Faculty of Medicine.
Key inclusion criteria (2 listed)
- Male or female patients older than 18 years.
- Patients with IBD are diagnosed by clinical, radiological, endoscopic, and histological criteria.
Key exclusion criteria (2 listed)
- Patients aged < 18 years
- Unwilling to participate in our study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| History of IBD course and outcome in HBV patientsFull 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)). | Other | IBD Patients with negative HBV infection, IBD patients with positive HBV infection. |
Primary outcome
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
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
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
Related trials for Inflammatory Bowel Disease (IBD)
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nabila A Elgazzar, MD study director
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD) and Hepatitis B Virus, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rania M Elkafoury, MD (+201004672358, rania.elkafoury@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with severe IBD measured by Truelove-Witts severity index (time frame: through study completion, an average of 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.