Inflammatory Bowel DiseasesNCT05967650
Efficacy of Accelerated Versus Standard Regiment of Hepatitis B Virus Vaccine Among Inflammatory Bowel Disease Patients
A study testing standard hepatitis B vaccine and accelerated HBV Vaccine in people with Inflammatory Bowel Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that includes ulcerative colitis (UC) and Crohn's disease (CD) . They mainly affect young populations, altering their quality of life and increasing morbidity, compared to the general population . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- standard hepatitis B vaccine and accelerated HBV Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of inflammatory bowel disease (IBD).
- Completed Phase 1 serological screening.
- Seronegative for hepatitis B surface antigen (HBsAg).
- Non-immune to HBV, defined as a hepatitis B surface antibody (anti-HBs) concentration of < 10 mIU/mL.
Who cannot join
- Refusal to provide informed consent for the screening phase.
- Phase 2: Vaccination and Randomization
- Evidence of active or past HBV infection (e.g., positive HBsAg or positive total anti-HBc identified during Phase 1).
- History of recent HBV vaccination (note: prior routine childhood HBV vaccination administered during infancy is permitted and is not an exclusion)
- Refusal to participate in the vaccination and randomization phase.
Trial locations and contacts
1 site in 1 country.
About this study
Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that includes ulcerative colitis (UC) and Crohn's disease (CD) . They mainly affect young populations, altering their quality of life and increasing morbidity, compared to the general population . The etiology and pathogenesis of IBD are still poorly understood.
Inflammatory bowel disease (IBD) patients are at an increased risk of contracting and developing complications from hepatitis B virus (HBV) due to their weakened immune systems and frequent use of immunosuppressive medications. The traditional HBV vaccine regimen requires three doses over six months to achieve full immunity, which can be challenging for IBD patients who may have difficulty adhering to the schedule or may not respond well to the vaccine
Read the detailed description
Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that includes ulcerative colitis (UC) and Crohn's disease (CD) . They mainly affect young populations, altering their quality of life and increasing morbidity, compared to the general population . The etiology and pathogenesis of IBD are still poorly understood. The pathogenesis of IBD involves genetic factors and environmental factors . In Egypt, the prevalence of IBD has been increasing in recent years.
Patients with inflammatory bowel illnesses are more susceptible to viral infections. In people with IBD, viral infections have emerged as a significant issue. Viral infections are often difficult to identify and have a high morbidity and fatality rate.
The hepatitis B virus is a widespread infection worldwide. HBV is a DNA virus of the Hepadnaviridae family that is a significant cause of morbidity and mortality . Hepatitis B virus (HBV) infection is a global health problem with a continuously increasing burden in developing countries like Egypt.
The prevalence of HBV in Egypt remains a significant public health concern, with a pooled prevalence of 3.67%. However, the introduction of the HBV vaccination program in 1992 has led to a decrease in prevalence among low-risk populations, with a pooled prevalence estimate of 1.93%. This highlights the importance of continued efforts to promote and expand HBV vaccination programs in Egypt.Notably, children under 20 with a history of HBV vaccination in infancy had the lowest prevalence of 0.69%, indicating the effectiveness of HBV vaccination during infancy in providing adequate protection. This underscores the need for increasing vaccination coverage among infants and young children in Egypt.However, the prevalence of HBV in pregnant females was still high among low-risk groups, with a pooled prevalence of 2.9%. This highlights the importance of targeted interventions to prevent mother-to-child transmission of HBV, such as screening pregnant women for HBV and providing antiviral therapy to those who test positive.Overall, while progress has been made in reducing the prevalence of HBV in Egypt, continued efforts are needed to further decrease the burden of this disease and prevent its transmission.
Inflammatory bowel disease (IBD) patients are at an increased risk of contracting and developing complications from hepatitis B virus (HBV) due to their weakened immune systems and frequent use of immunosuppressive medications. The traditional HBV vaccine regimen requires three doses over six months to achieve full immunity, which can be challenging for IBD patients who may have difficulty adhering to the schedule or may not respond well to the vaccine. An accelerated HBV vaccine regimen has been developed that allows for faster immunity with fewer doses, but its efficacy in IBD patients to be investigated.[5]
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- standard hepatitis B vaccine, accelerated HBV Vaccine
- Keywords
- Hepatitis B vaccines
- 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.
standard hepatitis B vaccineBiological
This study utilized a two-step design. Initially, 100 consecutive patients with inflammatory bowel disease (IBD) underwent baseline serological screening for hepatitis B virus (HBV), including HBsAg, total anti-HBc, and anti-HBs. Protective immunity was defined as an anti-HBs concentration of 10 mIU/mL.
Following the screening phase, patients lacking HBV immunity (non-vaccinated or non-immune) were randomized to receive either an accelerated or a standard HBV vaccination regimen as pilot study
accelerated HBV VaccineBiological
IBD patients with negative HBV will be diveded in to two arms second arm vaccinated with accelerated HBV vaccine regemin( dose 1.2.3)
| Study group | Role | What they receive |
|---|---|---|
| HBV vaccination of Inflammatory bowel disease patients with stander regemin | Active comparator | inflammatory bowel disease patient with negative HBVs AB will be vaccinated with standerd regemin HBV vaccination
1. st dose zero
2. nd dose after 1 months
3. rd dose after 6 months Receives: Biological: standard hepatitis B vaccine |
| HBV vaccination of Inflammatory bowel disease patients with accelearetd regemin | Active comparator | inflammatory bowel disease patient with negative HBVs AB will be vaccinated with standerd regemin HBV vaccination
1. st dose zero
2. nd dose after 1months
3. rd dose after 3 months Receives: Biological: accelerated HBV Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of IBD patients with negative HBs Ab
IBD patients at Alraghy hospital will be tested for HBsAg, HBcAb and HBsAb titre by IU
Measured: 2 months
Secondary outcomes (1)
efficacy of accelerated HBV vaccine regimen versus standard HBV vaccine regiment among IBD patients already receive treatment (as pilot study)
accelearted HBV vaccine will be given at( dose 0 ,1,3) mothns while standard HBV vaccine regemin( dose 0.1.6) efficacy of both regimen assessed by measurement of HBs Ab titre by IU
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jan 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study utilizes a prospective, two-phase design to evaluate hepatitis B virus (HBV) immunity and vaccination efficacy in patients with inflammatory bowel disease (IBD). The trial consists of an initial observational screening phase followed by an interventional randomized controlled phase.Phase 1: Observational Screening PhaseObjective: To determine the baseline seroprevalence of HBV markers and identify patients who lack protective immunity.Methodology: A total of 100 consecutive patients with a confirmed diagnosis of IBD will be enrolled. All participants will undergo baseline HBV serological testing, which includes Hepatitis B surface antigen (HBsAg), total Hepatitis B core antibody (anti-HBc), and Hepatitis B surface antibody (anti-HBs).Classification: Patients will be categorized based on their immune status. Protective immunity is defined as an anti-HBs concentration of 10 mIU/mL. Phase 2: Interventional (Randomization and Vaccination)
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Sabry, Assiut University
- Investigators
- bahaa os taha, Study chair, Assiut Universitylobna ah abdelwahed, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967650
- Sponsor's protocol ID
- HBV vaccines in IBD patients
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abraham C, Cho JH. Inflammatory bowel disease. N Engl J Med. 2009 Nov 19;361(21):2066-78. doi: 10.1056/NEJMra0804647. No abstract available.
PubMed 19923578Fabian O, Kamaradova K. Morphology of inflammatory bowel diseases (IBD). Cesk Patol. 2022 Spring;58(1):27-37.
PubMed 35387455Molodecky NA, Kaplan GG. Environmental risk factors for inflammatory bowel disease. Gastroenterol Hepatol (N Y). 2010 May;6(5):339-46.
PubMed 20567592Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14.
PubMed 22001864Kaplan GG, Ng SC. Understanding and Preventing the Global Increase of Inflammatory Bowel Disease. Gastroenterology. 2017 Feb;152(2):313-321.e2. doi: 10.1053/j.gastro.2016.10.020. Epub 2016 Oct 25.
PubMed 27793607Gholizadeh O, Akbarzadeh S, Moein M, Yasamineh S, Hosseini P, Afkhami H, Amini P, Dadashpour M, Tahavvori A, Eslami M, Hossein Taherian M, Poortahmasebi V. The role of non-coding RNAs in the diagnosis of different stages (HCC, CHB, OBI) of hepatitis B infection. Microb Pathog. 2023 Mar;176:105995. doi: 10.1016/j.micpath.2023.105995. Epub 2023 Jan 18.
PubMed 36681203Azzam A, Khaled H, Elbohy OA, Mohamed SA, Mohamed SMH, Abdelkader AH, Ezzat AA, Elmowafy AOI, El-Emam OA, Awadalla M, Refaey N, Rizk SMA. Seroprevalence of hepatitis B virus surface antigen (HBsAg) in Egypt (2000-2022): a systematic review with meta-analysis. BMC Infect Dis. 2023 Mar 10;23(1):151. doi: 10.1186/s12879-023-08110-5.
PubMed 36899311Fernandez Sanchez-Escalonilla S, Esparcia Rodriguez O, Lopez Canto S, Cantero Escribano JM, Molina Cabrero FJ, Gomez-Juarez Sango A, Garcia Guerrero J. [Vaccination against hepatitis B in patients with inflammatory bowel disease: immune response and associated factors.]. Rev Esp Salud Publica. 2022 Feb 18;96:e202202020. Spanish.
PubMed 35179147Ridola L, Zullo A, Lagana B, Lorenzetti R, Migliore A, Pica R, Picchianti Diamanti A, Gigliucci G, Scolieri P, Bruzzese V. Hepatitis B (HBV) reactivation in patients receiving biologic therapy for chronic inflammatory diseases in clinical practice. Ann Ist Super Sanita. 2021 Jul-Sep;57(3):244-248. doi: 10.4415/ANN_21_03_08.
PubMed 34554119
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Accelerated Versus Standard Regiment of Hepatitis B Virus Vaccine Among Inflammatory Bowel Disease Patients
- ClinicalTrials.gov ID
- NCT05967650
- Acronym / sponsor ID
- HBV vaccines in IBD patients
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Hepatitis B vaccines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 1 Aug 2023 (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.
Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that includes ulcerative colitis (UC) and Crohn's disease (CD) . They mainly affect young populations, altering their quality of life and increasing morbidity, compared to the general population . The etiology and pathogenesis of IBD are still poorly understood.
Inflammatory bowel disease (IBD) patients are at an increased risk of contracting and developing complications from hepatitis B virus (HBV) due to their weakened immune systems and frequent use of immunosuppressive medications. The traditional HBV vaccine regimen requires three doses over six months to achieve full immunity, which can be challenging for IBD patients who may have difficulty adhering to the schedule or may not respond well to the vaccine
Detailed description
Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that includes ulcerative colitis (UC) and Crohn's disease (CD) . They mainly affect young populations, altering their quality of life and increasing morbidity, compared to the general population . The etiology and pathogenesis of IBD are still poorly understood. The pathogenesis of IBD involves genetic factors and environmental factors . In Egypt, the prevalence of IBD has been increasing in recent years.
Patients with inflammatory bowel illnesses are more susceptible to viral infections. In people with IBD, viral infections have emerged as a significant issue. Viral infections are often difficult to identify and have a high morbidity and fatality rate.
The hepatitis B virus is a widespread infection worldwide. HBV is a DNA virus of the Hepadnaviridae family that is a significant cause of morbidity and mortality . Hepatitis B virus (HBV) infection is a global health problem with a continuously increasing burden in developing countries like Egypt.
The prevalence of HBV in Egypt remains a significant public health concern, with a pooled prevalence of 3.67%. However, the introduction of the HBV vaccination program in 1992 has led to a decrease in prevalence among low-risk populations, with a pooled prevalence estimate of 1.93%. This highlights the importance of continued efforts to promote and expand HBV vaccination programs in Egypt.Notably, children under 20 with a history of HBV vaccination in infancy had the lowest prevalence of 0.69%, indicating the effectiveness of HBV vaccination during infancy in providing adequate protection. This underscores the need for increasing vaccination coverage among infants and young children in Egypt.However, the prevalence of HBV in pregnant females was still high among low-risk groups, with a pooled prevalence of 2.9%. This highlights the importance of targeted interventions to prevent mother-to-child transmission of HBV, such as screening pregnant women for HBV and providing antiviral therapy to those who test positive.Overall, while progress has been made in reducing the prevalence of HBV in Egypt, continued efforts are needed to further decrease the burden of this disease and prevent its transmission.
Inflammatory bowel disease (IBD) patients are at an increased risk of contracting and developing complications from hepatitis B virus (HBV) due to their weakened immune systems and frequent use of immunosuppressive medications. The traditional HBV vaccine regimen requires three doses over six months to achieve full immunity, which can be challenging for IBD patients who may have difficulty adhering to the schedule or may not respond well to the vaccine. An accelerated HBV vaccine regimen has been developed that allows for faster immunity with fewer doses, but its efficacy in IBD patients to be investigated.[5]
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study utilizes a prospective, two-phase design to evaluate hepatitis B virus (HBV) immunity and vaccination efficacy in patients with inflammatory bowel disease (IBD). The trial consists of an initial observational screening phase followed by an interventional randomized controlled phase.Phase 1: Observational Screening PhaseObjective: To determine the baseline seroprevalence of HBV markers and identify patients who lack protective immunity.Methodology: A total of 100 consecutive patients with a confirmed diagnosis of IBD will be enrolled. All participants will undergo baseline HBV serological testing, which includes Hepatitis B surface antigen (HBsAg), total Hepatitis B core antibody (anti-HBc), and Hepatitis B surface antibody (anti-HBs).Classification: Patients will be categorized based on their immune status. Protective immunity is defined as an anti-HBs concentration of 10 mIU/mL. Phase 2: Interventional (Randomization and Vaccination)
| Arm | Type | Receives |
|---|---|---|
| HBV vaccination of Inflammatory bowel disease patients with stander regemin | Active comparator | Biological: standard hepatitis B vaccineinflammatory bowel disease patient with negative HBVs AB will be vaccinated with standerd regemin HBV vaccination 1. st dose zero 2. nd dose after 1 months 3. rd dose after 6 months |
| HBV vaccination of Inflammatory bowel disease patients with accelearetd regemin | Active comparator | Biological: accelerated HBV Vaccineinflammatory bowel disease patient with negative HBVs AB will be vaccinated with standerd regemin HBV vaccination 1. st dose zero 2. nd dose after 1months 3. rd dose after 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of inflammatory bowel disease (IBD).
- Completed Phase 1 serological screening.
- Seronegative for hepatitis B surface antigen (HBsAg).
- Non-immune to HBV, defined as a hepatitis B surface antibody (anti-HBs) concentration of < 10 mIU/mL.
Key exclusion criteria (5 listed)
- Refusal to provide informed consent for the screening phase.
- Phase 2: Vaccination and Randomization
- Evidence of active or past HBV infection (e.g., positive HBsAg or positive total anti-HBc identified during Phase 1).
- History of recent HBV vaccination (note: prior routine childhood HBV vaccination administered during infancy is permitted and is not an exclusion)
- Refusal to participate in the vaccination and randomization phase.
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 |
|---|---|---|
| standard hepatitis B vaccineThis study utilized a two-step design. Initially, 100 consecutive patients with inflammatory bowel disease (IBD) underwent baseline serological screening for hepatitis B virus (HBV), including HBsAg, total anti-HBc, and anti-HBs. Protective immunity was defined as an anti-HBs concentration of 10 mIU/mL. Following the screening phase, patients lacking HBV immunity (non-vaccinated or non-immune) were randomized to receive either an accelerated or a standard HBV vaccination regimen as pilot study | Biological | HBV vaccination of Inflammatory bowel disease patients with stander regemin |
| accelerated HBV VaccineIBD patients with negative HBV will be diveded in to two arms second arm vaccinated with accelerated HBV vaccine regemin( dose 1.2.3) | Biological | HBV vaccination of Inflammatory bowel disease patients with accelearetd regemin |
Primary outcome
frequency of IBD patients with negative HBs Ab
Time frame: 2 months
IBD patients at Alraghy hospital will be tested for HBsAg, HBcAb and HBsAb titre by IU
1 secondary outcome
efficacy of accelerated HBV vaccine regimen versus standard HBV vaccine regiment among IBD patients already receive treatment (as pilot study)
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 19923578Abraham C, Cho JH. Inflammatory bowel disease. N Engl J Med. 2009 Nov 19;361(21):2066-78. doi: 10.1056/NEJMra0804647. No abstract available.
- Background: PubMed 35387455Fabian O, Kamaradova K. Morphology of inflammatory bowel diseases (IBD). Cesk Patol. 2022 Spring;58(1):27-37.
- Background: PubMed 20567592Molodecky NA, Kaplan GG. Environmental risk factors for inflammatory bowel disease. Gastroenterol Hepatol (N Y). 2010 May;6(5):339-46.
- Background: PubMed 22001864Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14.
- Background: PubMed 27793607Kaplan GG, Ng SC. Understanding and Preventing the Global Increase of Inflammatory Bowel Disease. Gastroenterology. 2017 Feb;152(2):313-321.e2. doi: 10.1053/j.gastro.2016.10.020. Epub 2016 Oct 25.
- Background: PubMed 36681203Gholizadeh O, Akbarzadeh S, Moein M, Yasamineh S, Hosseini P, Afkhami H, Amini P, Dadashpour M, Tahavvori A, Eslami M, Hossein Taherian M, Poortahmasebi V. The role of non-coding RNAs in the diagnosis of different stages (HCC, CHB, OBI) of hepatitis B infection. Microb Pathog. 2023 Mar;176:105995. doi: 10.1016/j.micpath.2023.105995. Epub 2023 Jan 18.
- Background: PubMed 36899311Azzam A, Khaled H, Elbohy OA, Mohamed SA, Mohamed SMH, Abdelkader AH, Ezzat AA, Elmowafy AOI, El-Emam OA, Awadalla M, Refaey N, Rizk SMA. Seroprevalence of hepatitis B virus surface antigen (HBsAg) in Egypt (2000-2022): a systematic review with meta-analysis. BMC Infect Dis. 2023 Mar 10;23(1):151. doi: 10.1186/s12879-023-08110-5.
- Background: PubMed 35179147Fernandez Sanchez-Escalonilla S, Esparcia Rodriguez O, Lopez Canto S, Cantero Escribano JM, Molina Cabrero FJ, Gomez-Juarez Sango A, Garcia Guerrero J. [Vaccination against hepatitis B in patients with inflammatory bowel disease: immune response and associated factors.]. Rev Esp Salud Publica. 2022 Feb 18;96:e202202020. Spanish.
- Background: PubMed 34554119Ridola L, Zullo A, Lagana B, Lorenzetti R, Migliore A, Pica R, Picchianti Diamanti A, Gigliucci G, Scolieri P, Bruzzese V. Hepatitis B (HBV) reactivation in patients receiving biologic therapy for chronic inflammatory diseases in clinical practice. Ann Ist Super Sanita. 2021 Jul-Sep;57(3):244-248. doi: 10.4415/ANN_21_03_08.
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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. This study is not recruiting at the moment.
bahaa os taha study chair
Assiut University
lobna ah abdelwahed study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard hepatitis B vaccine and accelerated HBV Vaccine in people with Inflammatory Bowel Diseases, run by Assiut 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of IBD patients with negative HBs Ab (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05967650, which also lists 9 linked publications.
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 15 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.