- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01010815
Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis
November 9, 2009 updated by: Seoul National University Hospital
The researchers will investigate gut microbiome in Korean patients with ulcerative colitis and normal control subjects using metagenomic analysis to elucidate the significant difference between two groups This study will help to understand the association between gut microbiome and inflammatory bowel disease.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joo Sung Kim, M.D., PhD
- Phone Number: +82-2-740-8112
- Email: jooskim@snu.ac.kr
Study Contact Backup
- Name: Seong-Joon Koh, M.D.
- Phone Number: +82-2-740-8112
- Email: jel1206@medimail.co.kr
Study Locations
-
-
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Seoul, Korea, Republic of, 110-744
- Recruiting
- Seoul National University Hospital
-
Contact:
- Joo Sung Kim, Ph.D
- Phone Number: 82-2-740-8112
- Email: jooskim@snu.ac.kr
-
Contact:
- Seong-Joon Koh
- Phone Number: 82-2-740-8112
- Email: jel1206@medimail.co.kr
-
-
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
Ages Eligible for Study
19 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
gastroenterology clinic at SNUH(Seoul National University Hospital)
Description
Inclusion Criteria:
- Between the age of 19 and 75 years
- willing to consent/undergo necessary procedures
- clinically active or inactive Ulcerative colitis
Exclusion Criteria:
- Inability to provide informed consent or
- Clinically severe or fulminant ulcerative colitis
- Previous abdominal surgery
- Pregnancy
- Clinically or laboratory-confirmed gastroenteritis for at least 3 months before sampling
- the use of antibiotics in the past a month before sampling
- the use of probiotics in the past a month before sampling
- Severe cardiovascular or pulmonary disease
- Severe convulsive disorder and current use of anti-convulsive medication
- Malignancy
- Transplantation
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
UC group
clinically and microscopically confirmed UC patients between the age of 19 and 75 years
|
Stool will be collected from participants at study entry
colonoscopy biopsy will be conducted in rectum, ascending and descending colon from participants 2 times during study - at active phase and inactive phase
stool will be collected from participants 2 times during study - at active phase and inactive phase
|
Control group
normal healthy controls
|
Stool will be collected from participants at study entry
stool will be collected from participants 2 times during study - at active phase and inactive phase
Colonoscopy biopsy will be performed in rectum, ascending and descending colon at study entry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
characterize the difference in gut microbiomes through metagenomic analysis between UC patients and normal control subjects
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
characterize the difference in gut microbiomes through metagenomic analysis between stool specimens and biopsy specimens in participants with UC and normal subjects
Time Frame: 1 year
|
1 year
|
characterize the difference in gut microbiomes among colonoscopy biopsy locations (rectum, ascending and descending colon)
Time Frame: 1 year
|
1 year
|
characterize the difference in gut microbiomes between active and inactive UC patients
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
November 1, 2009
Primary Completion (Anticipated)
November 1, 2010
Study Completion (Anticipated)
November 1, 2011
Study Registration Dates
First Submitted
November 8, 2009
First Submitted That Met QC Criteria
November 9, 2009
First Posted (Estimate)
November 10, 2009
Study Record Updates
Last Update Posted (Estimate)
November 10, 2009
Last Update Submitted That Met QC Criteria
November 9, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gut Microbiome in UC Patients
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.
Clinical Trials on Ulcerative Colitis
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Ferring PharmaceuticalsCompletedActive Ulcerative Colitis | Remission of Ulcerative ColitisCanada
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Palatin Technologies, IncRecruitingUlcerative Colitis | Ulcerative Colitis Flare | Ulcerative Colitis Acute | UlcerativeUnited States
-
Theravance BiopharmaCompletedUlcerative Colitis, Active Severe | Ulcerative Colitis, Active ModerateUnited States, Georgia, Moldova, Republic of, Romania
-
Rise Therapeutics LLCUniversity of Colorado, Denver; Mayo ClinicRecruitingUlcerative Colitis | Ulcerative Colitis Chronic Moderate | Ulcerative Colitis Chronic | Ulcerative Colitis Chronic MildUnited States
-
Assistance Publique - Hôpitaux de ParisMRSU 938 - Research Center of Saint AntoineNot yet recruitingPediatric Ulcerative Colitis in RemissionFrance
-
Protagonist Therapeutics, Inc.CompletedUlcerative Colitis Chronic Moderate | Ulcerative Colitis Chronic SevereUnited States, Austria, Bulgaria, Canada, Georgia, Germany, Hungary, Italy, Korea, Republic of, Poland, Russian Federation, Serbia, Ukraine
-
Theravance BiopharmaCompletedActive Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy SubjectsUnited States
-
Altheus Therapeutics, Inc.UnknownUlcerative Colitis | Left-sided Ulcerative Colitis | Distal Ulcerative ColitisUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...University Medical Center Groningen; UMC UtrechtRecruitingUlcerative Colitis | Ulcerative Colitis Flare | Ulcerative Colitis AcuteNetherlands
-
Immune PharmaceuticalsUnknownUlcerative Colitis, Active Severe | Ulcerative Colitis, Active ModerateIsrael
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-
Mayo ClinicEnrolling by invitation
-
Luxembourg Institute of HealthIntegrated Biobank of Luxembourg; Centre Hospitalier du LuxembourgCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedEnteropathy, Necrotizing EnterocolitisFrance
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The Affiliated Nanjing Drum Tower Hospital of Nanjing...Completed
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