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

Ulcerative Colitis Clinical Trial

— GIVES-21  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04748627
• Other study ID #: GIVES-21
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: November 2023
• Source: Chinese University of Hong Kong
• Contact: Siew Chien Ng, PhD
• Phone: 852-35053996
• Email: siewchienng[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Diagnosis of any chronic medical illnesses.

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	University of Calgary

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	Geographical effect	To study the geographical effect on: 5-amino-salicylic acid, corticosteroids, immunosuppressive agents, biologics and surgery.	1 year