- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01140802
Gut Microbiota in the Healthy Population, Inflammatory Bowel Disease Patients, and Their Relatives
A Study of the Gut Microbiota in the Healthy Population, Patients With Inflammatory Bowel Disease and Their Relatives (IBD Microbe Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Hong Kong, Hong Kong
- Prince of Wales Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To identify specific gut microbiota in IBD patients
Time Frame: 2 years
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Dominant species from colonic tissue and stool samples including bacteroides, bifidobacteria, firmucutes (using microarray analysis and pyrosequencing)
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To identify environmental risk factors
Time Frame: 2 years
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A validated Enviromental risk factor questionnaire by International Organisation of Inflammatory Bowel Disease
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2 years
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To identify genetic differences among IBD patients, their relatives and the control subjects
Time Frame: 2 years
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To measure common known genetic variants including NOD2 mutation, IL23R, TNFSF15, etc from blood samples
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2 years
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To identify disease characteristics among IBD patients
Time Frame: 2 years
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Disease characteristics including disease behavior, disease location and progression according to Montreal Classification.
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2 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBD Microbe
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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