Gut Microbiota in the Healthy Population, Inflammatory Bowel Disease Patients, and Their Relatives
The aim of this study is to compare the gut microbiota in Chinese patients with Inflammatory Bowel Disease (IBD) in Hong Kong with that of healthy controls, compare the gut microbiota in IBD patients in a developing country (low but increasing IBD incidence, Hong Kong) with those in a developed country (high incidence, Australia), compare the gut microbiota in Chinese patients with IBD in Hong Kong with the microbiota of their non-IBD affected parents and siblings.
Inflammatory Bowel Disease
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Study of the Gut Microbiota in the Healthy Population, Patients With Inflammatory Bowel Disease and Their Relatives (IBD Microbe Study|
- To identify specific gut microbiota in IBD patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]Dominant species from colonic tissue and stool samples including bacteroides, bifidobacteria, firmucutes (using microarray analysis and pyrosequencing)
- To identify environmental risk factors [ Time Frame: 2 years ] [ Designated as safety issue: No ]A validated Enviromental risk factor questionnaire by International Organisation of Inflammatory Bowel Disease
- To identify genetic differences among IBD patients, their relatives and the control subjects [ Time Frame: 2 years ] [ Designated as safety issue: No ]To measure common known genetic variants including NOD2 mutation, IL23R, TNFSF15, etc from blood samples
- To identify disease characteristics among IBD patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]Disease characteristics including disease behavior, disease location and progression according to Montreal Classification.
Biospecimen Retention: Samples With DNA
Serum DNA will be collected and stored only if patients have provided consent separately. All serum DNA blood samples will be anonymised. Genetic results will not be made available to individual patients in a future date as there is no evidence to support genetic testing for risk prediction in routine practice, but these large scale genetic results will be useful to identify relevant future therapeutic targets for treatment of IBD. 10 ml of blood will be collected in EDTA tubes and stored at minus 80 degrees C, These samples will be transported to China for analysis at a later date.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Crohn's disease or ulcerative colitis patients
Healthy controls (non-IBD)
Patients comprise ethnicity - matched patients undergoing colonoscopy for polyp or colorectal cancer screening, or rectal bleeding
Relatives of IBD patients
They will be a first degree relative of a IBD patient.
Crohn's disease and ulcerative colitis are chronic inflammatory disorders of the gut that cause major life-long disability. Afflicting mostly young people at an age when they are most active both in their private and professional life, inflammatory bowel disease (IBD) represents an important public health problem affecting both the patients education, working abilities, social life and quality of life. Previously a disease predominantly of the West, there is now a marked increase in the incidence of IBD in Hong Kong. The cause of this dramatic increase over the last decade is unknown. Genetic factors, environmental factors and the gut bacteria may play a role in disease development. This study aims to explore the factors that may be contributing to, or causing, the rise of IBD in Hong Kong. The investigators propose to study the gut bacteria in Chinese patients with IBD compared with non-IBD patients, and healthy relatives of IBD patients. IBD patients will be prospectively recruited, blood samples will be obtained for serology and genotyping, stool samples and biopsies will be collected during routine colonoscopy for microbiota analysis. Bloods, stool and tissue gut microbiota from non-IBD patients will be collected for comparison. Studying gut microbiota, genetics and environmental factors in populations with changing incidence of IBD offers the greatest hope of identifying potentially important causative factors for disease.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140802
|Contact: Siew C NG, PhDfirstname.lastname@example.org|
|Contact: Kim W AU, MScemail@example.com|
|Prince of Wales Hospital||Recruiting|
|Shatin, Hong Kong|
|Contact: Siew C NG, PhD +85226373509 firstname.lastname@example.org|
|Contact: Kim W AU, MSc +85226322640 email@example.com|
|Sub-Investigator: Joseph J SUNG, MD|
|Sub-Investigator: Dorothy K CHOW|
|Sub-Investigator: Francis K CHAN, MD|
|Sub-Investigator: Justin C WU, MD|
|Sub-Investigator: James Y LAU, MD|
|Principal Investigator:||Siew C NG, PhD||Chinese University of Hong Kong|