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Global IBD Visualization of Epidemiology Studies (GIVES) in the 21st Century

Global IBD Visualization of Epidemiology Studies (GIVES) in the 21st Century (GIVES-21)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04748627
Acronym
GIVES-21
Enrollment
400
Registered
2021-02-10
Start date
2021-10-01
Completion date
2023-12-31
Last updated
2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Inflammatory Bowel Diseases, Ulcerative Colitis

Brief 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. 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.

Interventions

None listed

Sponsors

University of Calgary
CollaboratorOTHER
Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

For IBD patients: Inclusion Criteria: * 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

Exclusion criteria

* Nil For healthy control: Inclusion criteria: * Aged ≥ 18 years old * Asymptomatic * Written informed consent obtained

Design outcomes

Primary

MeasureTime frameDescription
Incidence of IBD1 yearTo determine the incidence of IBD in 19 regions globally, and to investigate if this increase is caused by environmental and dietary factors.

Secondary

MeasureTime frameDescription
Geographical effect1 yearTo study the geographical effect on: 5-amino-salicylic acid, corticosteroids, immunosuppressive agents, biologics and surgery.

Countries

Hong Kong

Contacts

Primary ContactSiew Chien Ng, PhD
siewchienng@cuhk.edu.hk852-35053996
Backup ContactJoyce WY Mak
wingyanmak@cuhk.edu.hk852-35053996

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026