Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis

NCT01010815 | Unknown

• 1 other identifier: Gut Microbiome in UC Patients
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis; gut microbiome; metagenomics

Outcome Measures

Primary Outcomes (1)

• characterize the difference in gut microbiomes through metagenomic analysis between UC patients and normal control subjects

  1 year

Secondary Outcomes (3)

• characterize the difference in gut microbiomes through metagenomic analysis between stool specimens and biopsy specimens in participants with UC and normal subjects

  1 year

• characterize the difference in gut microbiomes among colonoscopy biopsy locations (rectum, ascending and descending colon)

  1 year

• characterize the difference in gut microbiomes between active and inactive UC patients

  1 year

Study Arms (2)

UC group

clinically and microscopically confirmed UC patients between the age of 19 and 75 years

Procedure: colonoscopy biopsy; Other: stool collection

Control group

normal healthy controls

Procedure: Colonoscopy biopsy; Other: stool collection

Interventions

colonoscopy biopsy PROCEDURE

Colonoscopy biopsy will be performed in rectum, ascending and descending colon at study entry

Control group

stool collection OTHER

Stool will be collected from participants at study entry

Control group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

gastroenterology clinic at SNUH(Seoul National University Hospital)

You may qualify if:

• Between the age of 19 and 75 years
• willing to consent/undergo necessary procedures
• clinically active or inactive Ulcerative colitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Food and Drug Safety, Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Joo Sung Kim, M.D., PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo Sung Kim, M.D., PhD

CONTACT

+82-2-740-8112; jooskim@snu.ac.kr

Seong-Joon Koh, M.D.

CONTACT

+82-2-740-8112; jel1206@medimail.co.kr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2009
• First Posted: November 10, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2011
• Last Updated: November 10, 2009

Record last verified: 2009-11

Locations

KR (1)