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

NCT01140802 | Terminated DMC

• 1 other identifier: IBD Microbe
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Keywords

First degree relatives; Crohn's disease; Ulcerative colitis; Healthy control

Outcome Measures

Primary Outcomes (1)

• To identify specific gut microbiota in IBD patients

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

  2 years

Secondary Outcomes (3)

• To identify environmental risk factors

  2 years

• To identify genetic differences among IBD patients, their relatives and the control subjects

  2 years

• To identify disease characteristics among IBD patients

  2 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

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.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Siew C NG, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 10, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)