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Gut Microbiota in the Healthy Population, Inflammatory Bowel Disease Patients, and Their Relatives

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01140802
First received: June 8, 2010
Last updated: February 2, 2015
Last verified: February 2015
History of Changes
  Purpose

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.


Condition
Inflammatory Bowel Disease

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.
Estimated Enrollment: 72
Study Start Date: March 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
IBD patients
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.

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

  • patients aged ≥18 with a diagnosis of Crohn's disease or ulcerative colitis defined by endoscopy, radiology and histology, patients on stable medication and informed consent obtained

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:

  • Patient group:

    1. current infection with an enteric pathogen,
    2. use of antibiotics within the last month,
    3. consumption of any probiotic or prebiotic within the last month,
    4. imminent need for surgery,
    5. requiring hospitalization,
    6. pregnancy or lactation,
    7. short bowel syndrome
    8. previous proctocolectomy
    9. significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the principal investigator,
    10. if they have a history of cancer with a disease free state of less than two years

Control and Relative group:

  1. previously been diagnosed with IBD
  2. they have a first or second degree relative with IBD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140802

Contacts
Contact: Siew C NG, PhD +85226373509 siewchienng@cuhk.edu.hk
Contact: Kim W AU, MSc +85226322640 kimau@surgery.cuhk.edu.hk

Locations
Hong Kong
Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Contact: Siew C NG, PhD    +85226373509    siewchienng@cuhk.edu.hk   
Contact: Kim W AU, MSc    +85226322640    kimau@surgery.cuhk.edu.hk   
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         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Siew C NG, PhD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Siew Chien NG, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01140802     History of Changes
Other Study ID Numbers: IBD Microbe
Study First Received: June 8, 2010
Last Updated: February 2, 2015
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
First degree relatives
Crohn's disease
Ulcerative colitis
Healthy control

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on March 03, 2015