Gut Microbiota in the Healthy Population, Inflammatory Bowel Disease Patients, and Their Relatives
Recruitment status was Recruiting
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| First Received Date ICMJE | June 8, 2010 | ||||||||
| Last Updated Date | June 11, 2010 | ||||||||
| Start Date ICMJE | March 2010 | ||||||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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) |
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| Original Primary Outcome Measures ICMJE |
To identify specific gut microbiota in IBD patients [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT01140802 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Gut Microbiota in the Healthy Population, Inflammatory Bowel Disease Patients, and Their Relatives | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: 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. |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Crohn's disease or ulcerative colitis patients as the case groups, Patients attend clinics or endoscopy for functional upper gastrointestinal diseases or screening colonoscopy as the control group, and the first degree relatives of IBD patients as the relative group |
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| Condition ICMJE | Inflammatory Bowel Disease | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 72 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Control group: Healthy controls (non-IBD patients) will comprise ethnicity - matched patients undergoing colonoscopy for polyp or colorectal cancer screening, or rectal bleeding. Controls will be excluded if they have previously been diagnosed with IBD or if they have a first or second degree relative with IBD. Relatives group: Relatives of patients will be aged between 16 and 35 years. They will be a first degree relative of a patient. Relatives older than 35 will not be recruited to maximise the chance of including some individuals who will develop IBD in the future. Relatives will be contacted either via the patient or directly by telephone by the investigators. They will be invited to attend for a screening meeting to assess eligibility and to receive the information sheets. They will undergo a flexible sigmoidoscopy/colonoscopy for biopsies once fully consented. Exclusion Criteria:
Control and Relative group:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Hong Kong | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01140802 | ||||||||
| Other Study ID Numbers ICMJE | IBD Microbe | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Siew Chien NG, Chinese University of Hong Kong | ||||||||
| Study Sponsor ICMJE | Chinese University of Hong Kong | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Chinese University of Hong Kong | ||||||||
| Verification Date | June 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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