Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02131168 |
| Other study ID # |
IBD EPI |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2011 |
| Est. completion date |
March 2021 |
Study information
| Verified date |
May 2023 |
| Source |
Chinese University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Crohn's disease and ulcerative colitis are inflammatory disorders of the gut which cause
major life-long disability. They affect males and females, with the commonest age of onset in
childhood, teens and early adult life. Previously restricted almost exclusively to the West,
these conditions are becoming much more common in Asian countries, including Hong Kong - the
cause of this dramatic change is unknown.
The cause of IBD is widely accepted as relating to the mucosal immune response to stimulation
from the gut bacteria, on a background of genetic susceptibility. The bacteria and other
organisms in the gut play a central role in the development of IBD in the West. However it is
unknown if the gut bacteria differ between Chinese patients with IBD and non-IBD (healthy
subjects) in Hong Kong, and whether it is affected by diet or changes in diet. A family
history is the largest risk factor for the disease. More than 50 different genes associated
with IBD have recently been identified in the West and preliminary data showed that Chinese
patients have a different genetic profile to Western populations.
This project aims to explore the true incidence of IBD in Hong Kong and factors that may be
contributing to, or causing, the increase of IBD in Hong Kong. Investigators aim to
investigate the number of new cases of IBD within a five year period and factors that may
account for the cases. Investigators will also study the choice of medical therapy, quality
of life and quality of health care in patients with IBD.
Description:
Investigators will create the first web-based Hong Kong inception cohort database. 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 our 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 (persistent or relapsing diarrhoea,
blood and/or mucus in the stools for more than three weeks, or abdominal pain and weight
loss). 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. New patients will be included during a five-year period,
01.04.2011 - 31.03.2016, followed by a five year follow-up period until 31.03.2021. 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 (see list of additional materials), and the database is located on a
central secured server.
