Inflammatory Bowel DiseasesGIVES-21NCT04748627
Global IBD Visualization of Epidemiology Studies (GIVES) in the 21st Century
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Crohn's disease (CD) and Ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) of unknown etiology. The pathophysiology of IBD relates to the mucosal immune response to antigenic stimulation from the gut microbiota secondary to environmental influence, on a background of genetic susceptibility. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- How many people
- 400 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2021to Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: For IBD patients: Newly diagnosed IBD patients in the local area For heathy control: Asymptomatic adults who have no IBD or any other chronic medical illnesses.
Who may be able to join
- Aged ≥ 18 years old
- Confirmed diagnosis of Crohn's disease or Ulcerative Colitis according to established clinical, endoscopic and histological criteria
- Written informed consent obtained
- Aged ≥ 18 years old
- Asymptomatic
- Written informed consent obtained
Who cannot join
- Nil
- For healthy control:
- Diagnosis of any chronic medical illnesses.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Siew Chien Ng, PhD, 35053996, siewchienng@cuhk.edu.hk
About this study
Official title: Global IBD Visualization of Epidemiology Studies (GIVES) in the 21st Century (GIVES-21)
Crohn's disease (CD) and Ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) of unknown etiology. The pathophysiology of IBD relates to the mucosal immune response to antigenic stimulation from the gut microbiota secondary to environmental influence, on a background of genetic susceptibility. IBD represents an important public health problem because it affects mostly young people at an age when they are most active in their private and professional life, and a management challenge because of its unpredictable relapsing nature. During the last few decades the incidence of IBD has changed in many ways. Incidence rates of traditionally high incidence areas such as the United States and Europe is remaining relatively stable or even decreasing, while the diseases have become more prevalent in previously low incidence areas, including Asia. Our latest systematic review has demonstrated that the highest reported prevalence of IBD was still in Europe and North America, however, the incidence of IBD has been rising in newly industrialized countries since 1990.
Read the detailed description
Investigators aim to study the incidence, demographic factors, and disease outcomes of IBD patients, environmental and dietary factors associated with IBD in 19 regions globally. Via the web registration, investigators intend to form a new prospective, uniformly diagnosed, population-based inception cohort of patients with IBD. Physicians, gastroenterologists, family doctors, surgeons and pathologists in the study area will be notified repeatedly about the study by letter, telephone, internet, personal visit of the investigators, and encouraged to inform investigators of every possible new case of IBD. Endoscopic, pathology and radiology records will be canvassed repeatedly for likely cases, both electronically and manually. By these methods, investigators intend to capture over 90% of possible cases. All patients are required to meet the diagnostic criteria for IBD on the basis of clinical symptoms, endoscopic or radiological evidence or mucosal biopsies. Infectious gastroenteritis, tuberculosis, entamoeba and cancer have to be ruled out. The web-based database application will be used for online registration of the various registration forms and questionnaires and the database is located on a central secured server. With the data collected, an online interactive atlas will be created which allows the community to visualize the most up-to-date epidemiology of IBD with the aims to promotes knowledge translation and research endeavours of stakeholders and provide infrastructure, resources, and expertise to define Crohn's disease burden in regions of the world where the disease is emerging.
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of IBD
To determine the incidence of IBD in 19 regions globally, and to investigate if this increase is caused by environmental and dietary factors.
Measured: 1 year
Secondary outcomes (1)
Geographical effect
To study the geographical effect on: 5-amino-salicylic acid, corticosteroids, immunosuppressive agents, biologics and surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Oct 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Principal investigator, Siew Chien NG, Chinese University of Hong Kong
- Investigators
- Siew Chien Ng, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748627
- Sponsor's protocol ID
- GIVES-21
- Acronym
- GIVES-21
- Status last verified
- Nov 2023
- First submitted
- 9 Feb 2021
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global IBD Visualization of Epidemiology Studies (GIVES) in the 21st Century (GIVES-21)
- ClinicalTrials.gov ID
- NCT04748627
- Acronym / sponsor ID
- GIVES-21 / GIVES-21
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Feb 2021 (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.
Crohn's disease (CD) and Ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) of unknown etiology. The pathophysiology of IBD relates to the mucosal immune response to antigenic stimulation from the gut microbiota secondary to environmental influence, on a background of genetic susceptibility. IBD represents an important public health problem because it affects mostly young people at an age when they are most active in their private and professional life, and a management challenge because of its unpredictable relapsing nature. During the last few decades the incidence of IBD has changed in many ways. Incidence rates of traditionally high incidence areas such as the United States and Europe is remaining relatively stable or even decreasing, while the diseases have become more prevalent in previously low incidence areas, including Asia. Our latest systematic review has demonstrated that the highest reported prevalence of IBD was still in Europe and North America, however, the incidence of IBD has been rising in newly industrialized countries since 1990.
Detailed description
Investigators aim to study the incidence, demographic factors, and disease outcomes of IBD patients, environmental and dietary factors associated with IBD in 19 regions globally. Via the web registration, investigators intend to form a new prospective, uniformly diagnosed, population-based inception cohort of patients with IBD. Physicians, gastroenterologists, family doctors, surgeons and pathologists in the study area will be notified repeatedly about the study by letter, telephone, internet, personal visit of the investigators, and encouraged to inform investigators of every possible new case of IBD. Endoscopic, pathology and radiology records will be canvassed repeatedly for likely cases, both electronically and manually. By these methods, investigators intend to capture over 90% of possible cases. All patients are required to meet the diagnostic criteria for IBD on the basis of clinical symptoms, endoscopic or radiological evidence or mucosal biopsies. Infectious gastroenteritis, tuberculosis, entamoeba and cancer have to be ruled out. The web-based database application will be used for online registration of the various registration forms and questionnaires and the database is located on a central secured server. With the data collected, an online interactive atlas will be created which allows the community to visualize the most up-to-date epidemiology of IBD with the aims to promotes knowledge translation and research endeavours of stakeholders and provide infrastructure, resources, and expertise to define Crohn's disease burden in regions of the world where the disease is emerging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For IBD patients: Newly diagnosed IBD patients in the local area For heathy control: Asymptomatic adults who have no IBD or any other chronic medical illnesses.
Key inclusion criteria (6 listed)
- Aged ≥ 18 years old
- Confirmed diagnosis of Crohn's disease or Ulcerative Colitis according to established clinical, endoscopic and histological criteria
- Written informed consent obtained
- Aged ≥ 18 years old
- Asymptomatic
Key exclusion criteria (3 listed)
- Nil
- Diagnosis of any chronic medical illnesses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of IBD
Time frame: 1 year
To determine the incidence of IBD in 19 regions globally, and to investigate if this increase is caused by environmental and dietary factors.
1 secondary outcome
Geographical effect
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
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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.
Siew Chien Ng, PhD principal investigator
Chinese University of Hong Kong
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 Diseases and Ulcerative Colitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Dec 2023. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siew Chien Ng, PhD (852-35053996, siewchienng@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of IBD (time frame: 1 year). 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 5 Dec 2023.