Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis

November 9, 2009 updated by: Seoul National University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

gastroenterology clinic at SNUH(Seoul National University Hospital)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
UC group
clinically and microscopically confirmed UC patients between the age of 19 and 75 years
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
Control group
normal healthy controls
Other: stool collection
Stool will be collected from participants at study entry
Other: stool collection
stool will be collected from participants 2 times during study - at active phase and inactive phase
Procedure: Colonoscopy biopsy
Colonoscopy biopsy will be performed in rectum, ascending and descending colon at study entry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
characterize the difference in gut microbiomes through metagenomic analysis between UC patients and normal control subjects
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year
characterize the difference in gut microbiomes among colonoscopy biopsy locations (rectum, ascending and descending colon)
Time Frame: 1 year
1 year
characterize the difference in gut microbiomes between active and inactive UC patients
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Food and Drug Safety, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

November 8, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (Estimate)

November 10, 2009

Study Record Updates

Last Update Posted (Estimate)

November 10, 2009

Last Update Submitted That Met QC Criteria

November 9, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gut Microbiome in UC Patients

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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