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18 Years
Open (Enrolling)
Inflammatory Bowel Disease

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Trial Information

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

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

Control and Relative group:

1. previously been diagnosed with IBD

2. they have a first or second degree relative with IBD

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

To identify specific gut microbiota in IBD patients

Outcome Description:

Dominant species from colonic tissue and stool samples including bacteroides, bifidobacteria, firmucutes (using microarray analysis and pyrosequencing)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Siew C NG, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese University of Hong Kong


Hong Kong: Department of Health

Study ID:

IBD Microbe



Start Date:

March 2010

Completion Date:

Related Keywords:

  • Inflammatory Bowel Disease
  • First degree relatives
  • Crohn's disease
  • Ulcerative colitis
  • Healthy control
  • Inflammatory Bowel Diseases
  • Intestinal Diseases