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

July 16, 2018 updated by: Siew Chien NG, Chinese University of Hong Kong

A Study of the Gut Microbiota in the Healthy Population, Patients With Inflammatory Bowel Disease and Their Relatives (IBD Microbe Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 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 disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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:

    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 years

Control and Relative group:

  1. previously been diagnosed with IBD
  2. they have a first or second degree relative with IBD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To identify environmental risk factors
Time Frame: 2 years
A validated Enviromental risk factor questionnaire by International Organisation of Inflammatory Bowel Disease
2 years
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
2 years
To identify disease characteristics among IBD patients
Time Frame: 2 years
Disease characteristics including disease behavior, disease location and progression according to Montreal Classification.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IBD Microbe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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