Gut Microbiota in the Healthy Population, Inflammatory Bowel Disease Patients, and Their Relatives
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ClinicalTrials.gov Identifier: NCT01140802 |
Recruitment Status
:
Active, not recruiting
First Posted
: June 10, 2010
Last Update Posted
: April 25, 2017
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Condition or disease |
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Inflammatory Bowel Disease |
Study Type : | Observational |
Estimated Enrollment : | 72 participants |
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 |
Actual Study Start Date : | March 2010 |
Estimated Primary Completion Date : | May 2017 |
Estimated Study Completion Date : | May 2017 |
Group/Cohort |
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IBD patients
Crohn's disease or ulcerative colitis patients
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Healthy controls (non-IBD)
Patients comprise ethnicity - matched patients undergoing colonoscopy for polyp or colorectal cancer screening, or rectal bleeding
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Relatives of IBD patients
They will be a first degree relative of a IBD patient.
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- To identify specific gut microbiota in IBD patients [ Time Frame: 2 years ]Dominant species from colonic tissue and stool samples including bacteroides, bifidobacteria, firmucutes (using microarray analysis and pyrosequencing)
- To identify environmental risk factors [ Time Frame: 2 years ]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 ]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 ]Disease characteristics including disease behavior, disease location and progression according to Montreal Classification.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140802
Hong Kong | |
Prince of Wales Hospital | |
Hong Kong, Hong Kong |
Principal Investigator: | Siew C NG, PhD | Chinese University of Hong Kong |
Responsible Party: | Siew Chien NG, Professor, Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT01140802 History of Changes |
Other Study ID Numbers: |
IBD Microbe |
First Posted: | June 10, 2010 Key Record Dates |
Last Update Posted: | April 25, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Siew Chien NG, Chinese University of Hong Kong:
First degree relatives Crohn's disease Ulcerative colitis Healthy control |
Additional relevant MeSH terms:
Intestinal Diseases Inflammatory Bowel Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |