Biobank - Investigating the Gut Microbiota, Genetics, Epigenetics and Metabolites
Investigating the Intestinal Microbiota, Epigenetic Markers and Body Fluid Metabolites to Identify Biomarkers for Inflammatory Bowel Diseases
1 other identifier
observational
6,000
1 country
1
Brief Summary
Inflammatory bowel disease (IBD) affects 1 in 500 to 1,000 people in the West. Previously a disease predominantly of the West, there is now a marked increase in the incidence of ulcerative colitis (UC) and Crohn's disease (CD) in Asia, with an estimated prevalence of 1 in 3,000 and 1 in 10,000 respectively\[1\]. The rapid increase of IBD in Asian raising concern of investigators. Therefore setting up a large scale biobank with comprehensive clinical data is require.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 27, 2018
CompletedFirst Posted
Study publicly available on registry
February 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2034
February 8, 2023
February 1, 2023
19.9 years
June 27, 2018
February 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Setup a large scale biobank
Set up a large scale biobank to collect data such as comprehensive clinical data, such as patient's demographic and clinical information (e.g. age, weight, gender, family history of IBD, appendectomy history, drug usage etc.)
20 years
Secondary Outcomes (7)
Intestinal microbiota of IBD patient
20 years
Genetics and epigenetic markers in IBD
20 years
Therapeutic drug monitoring
20 years
Biomarker of IBD
20 years
Pathobionts of IBD
20 years
- +2 more secondary outcomes
Study Arms (3)
Inflammatory Bowel Disease Patient
Patient with confirmed diagnosis of Inflammatory Bowel Disease
Healthy control
Controls (non-IBD) will comprise individuals undergoing colonoscopy for polyp or colorectal cancer screening, or investigations of gastrointestinal symptoms, and friends and spouses or partners of patients at Prince of Wales Hospital or Alice Ho Miu Ling Nethersole Hospital, or any individuals who are interested to participate in this study.
Healthy relatives of Inflammatory Bowel Disease patient
Relatives or household members of both patients with IBD or other diseases and controls will be recruited.
Eligibility Criteria
Patients with a diagnosis of Crohn's disease or ulcerative colitis defined by endoscopy, radiology and histology Control will comprise individuals undergoing colonoscopy for polyp or colorectal cancer screening, or investigations of gastrointestinal symptoms, and friends and spouses or partners of patients at Prince of Wales Hospital or Alice Ho Miu Ling Nethersole Hospital, or any individuals who are interested to participate in this study. Relatives or household members of both patients with IBD or other diseases and controls will be recruited.
You may qualify if:
- Patient ≥18 with a diagnosis of Crohn's disease or ulcerative colitis
- Informed Consent obtained
You may not qualify if:
- Known current infection with an enteric pathogen
- Previously been diagnosed with IBD (Control)
- Have a first of second degree relative with IBD (Control)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital
Hong Kong, Hong Kong
Biospecimen
Blood, Urine, Stool, Saliva and biopsies from gastrointestinal tract
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siew Chien Ng, PhD
Chinese University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 27, 2018
First Posted
February 27, 2019
Study Start
March 1, 2014
Primary Completion (Estimated)
February 1, 2034
Study Completion (Estimated)
July 1, 2034
Last Updated
February 8, 2023
Record last verified: 2023-02