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

November 8, 2009
November 9, 2009
November 2009
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01010815 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis
Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

gastroenterology clinic at SNUH(Seoul National University Hospital)

Ulcerative Colitis
  • 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
  • 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
  • UC group
    clinically and microscopically confirmed UC patients between the age of 19 and 75 years
    Interventions:
    • Procedure: colonoscopy biopsy
    • Other: stool collection
  • Control group
    normal healthy controls
    Interventions:
    • Procedure: Colonoscopy biopsy
    • Other: stool collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
November 2011
November 2010   (final data collection date for primary outcome measure)

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
Both
19 Years to 75 Years
Yes
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
Korea, Republic of
 
NCT01010815
Gut Microbiome in UC Patients
No
Joo Sung Kim, Seoul National University Hospital
Seoul National University Hospital
Ministry of Food and Drug Safety, Korea
Principal Investigator: Joo Sung Kim, M.D., PhD Seoul National University Hospital
Seoul National University Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP