Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis

• Conditions: Ulcerative Colitis
• Interventions: Procedure: colonoscopy biopsy; Other: stool collection

• Registration Number: NCT01010815
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-11
• Study Start: 2009-11
• Study First Submitted: 2009-11-08
• Study First Submitted QC: 2009-11-09
• Last Update Submitted: 2009-11-09
• Study First Posted: 2009-11-10
• Last Update Posted: 2009-11-10
• Primary Completion: 2010-11
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UC group	colonoscopy biopsy	clinically and microscopically confirmed UC patients between the age of 19 and 75 years
Control group	colonoscopy biopsy	normal healthy controls
UC group	stool collection	clinically and microscopically confirmed UC patients between the age of 19 and 75 years
Control group	stool collection	normal healthy controls

Primary Outcome Measures

Name	Time	Method
characterize the difference in gut microbiomes through metagenomic analysis between UC patients and normal control subjects	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of