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

History of Changes

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:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Bowel Movement Colonoscopy Ulcerative Colitis

U.S. FDA Resources

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 March 02, 2015

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