Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Food and Drug Safety, Korea
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01010815
First received: November 8, 2009
Last updated: November 9, 2009
Last verified: November 2009
  Purpose

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 Intervention
Ulcerative Colitis
Procedure: Colonoscopy biopsy
Other: stool collection
Procedure: colonoscopy biopsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • characterize the difference in gut microbiomes through metagenomic analysis between UC patients and normal control subjects [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • characterize the difference in gut microbiomes among colonoscopy biopsy locations (rectum, ascending and descending colon) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • characterize the difference in gut microbiomes between active and inactive UC patients [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Participants will need to give stool samples and colorectal biopsy specimens on 1 or 2 separate occasions


Estimated Enrollment: 15
Study Start Date: November 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 8, 2009
Last Updated: November 9, 2009
Health Authority: South Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 21, 2014