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Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT01010815
Recruitment Status : Unknown
Verified November 2009 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : November 10, 2009
Last Update Posted : November 10, 2009
Sponsor:
Collaborator:
Ministry of Food and Drug Safety, Korea
Information provided by:
Seoul National University Hospital

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Ulcerative Colitis Procedure: Colonoscopy biopsy Other: stool collection Procedure: colonoscopy biopsy

Study Design
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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis
Study Start Date : November 2009
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : November 2011

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U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
UC group
clinically and microscopically confirmed UC patients between the age of 19 and 75 years
 Procedure: colonoscopy biopsy
colonoscopy biopsy will be conducted in rectum, ascending and descending colon from participants 2 times during study - at active phase and inactive phase
Other: stool collection
stool will be collected from participants 2 times during study - at active phase and inactive phase
Control group
normal healthy controls
 Procedure: Colonoscopy biopsy
Colonoscopy biopsy will be performed in rectum, ascending and descending colon at study entry
Other: stool collection
Stool will be collected from participants at study entry


Outcome Measures
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Primary Outcome Measures :
  1. characterize the difference in gut microbiomes through metagenomic analysis between UC patients and normal control subjects [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]
  2. characterize the difference in gut microbiomes among colonoscopy biopsy locations (rectum, ascending and descending colon) [ Time Frame: 1 year ]
  3. characterize the difference in gut microbiomes between active and inactive UC patients [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Participants will need to give stool samples and colorectal biopsy specimens on 1 or 2 separate occasions

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
gastroenterology clinic at SNUH(Seoul National University Hospital)
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): NCT01010815


Contacts
Contact: Joo Sung Kim, M.D., PhD +82-2-740-8112 jooskim@snu.ac.kr
Contact: Seong-Joon Koh, M.D. +82-2-740-8112 jel1206@medimail.co.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Joo Sung Kim, Ph.D    82-2-740-8112    jooskim@snu.ac.kr   
Contact: Seong-Joon Koh    82-2-740-8112    jel1206@medimail.co.kr   
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Food and Drug Safety, Korea
Investigators
Principal Investigator: Joo Sung Kim, M.D., PhD Seoul National University Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Joo Sung Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01010815     History of Changes
Other Study ID Numbers: Gut Microbiome in UC Patients
First Posted: November 10, 2009    Key Record Dates
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by Seoul National University Hospital:
ulcerative colitis
gut microbiome
metagenomics

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases