Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01010815
• Other study ID #: Gut Microbiome in UC Patients
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2009
• Last updated: November 9, 2009
• Start date: November 2009
• Est. completion date: November 2011

Study information

• Verified date: November 2009
• Source: Seoul National University Hospital
• Contact: Joo Sung Kim, M.D., PhD
• Phone: +82-2-740-8112
• Email: jooskim[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Food and Drug Safety, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	characterize the difference in gut microbiomes through metagenomic analysis between UC patients and normal control subjects		1 year	No
Secondary	characterize the difference in gut microbiomes through metagenomic analysis between stool specimens and biopsy specimens in participants with UC and normal subjects		1 year	No
Secondary	characterize the difference in gut microbiomes among colonoscopy biopsy locations (rectum, ascending and descending colon)		1 year	No
Secondary	characterize the difference in gut microbiomes between active and inactive UC patients		1 year	Yes