Status:
TERMINATED
Gut Microbiota in the Healthy Population, Inflammatory Bowel Disease Patients, and Their Relatives
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Inflammatory Bowel Disease
Eligibility:
All Genders
18+ years
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 ...
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 t...
Eligibility Criteria
Inclusion
- 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
- Patient group:
- current infection with an enteric pathogen,
- use of antibiotics within the last month,
- consumption of any probiotic or prebiotic within the last month,
- imminent need for surgery,
- requiring hospitalization,
- pregnancy or lactation,
- short bowel syndrome
- previous proctocolectomy
- significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the principal investigator,
- if they have a history of cancer with a disease free state of less than two years
- Control and Relative group:
- previously been diagnosed with IBD
- they have a first or second degree relative with IBD
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01140802
Start Date
April 1 2010
End Date
January 1 2015
Last Update
July 18 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Prince of Wales Hospital
Hong Kong, Hong Kong