NCT02131168

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

10.2 years

First QC Date

April 29, 2014

Last Update Submit

May 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of new cases of IBD

    Data of new IBD case will be collected

    Up to 5 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Newly diagnosed IBD patients in the local area

You may qualify if:

  • All newly diagnosed IBD patients based on clinical, endoscopic, histologic or radiologic criteria will be included during the study period

You may not qualify if:

  • Any patients with a diagnosis of tuberculosis, infectious enteritis, amebiasis, or GI cancer that may mimic the diagnosis of IBD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

One stool sample will be collected for microbiology tests 10 ml of blood will be stored for genetic analysis

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Siew Chien Ng

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 29, 2014

First Posted

May 6, 2014

Study Start

January 1, 2011

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

May 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations