Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis

NCT ID: NCT01010815

Last Updated: 2009-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-11-30

Brief Summary

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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

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Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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UC group

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

colonoscopy biopsy

Intervention Type PROCEDURE

colonoscopy biopsy will be conducted in rectum, ascending and descending colon from participants 2 times during study - at active phase and inactive phase

stool collection

Intervention Type OTHER

stool will be collected from participants 2 times during study - at active phase and inactive phase

Control group

normal healthy controls

Colonoscopy biopsy

Intervention Type PROCEDURE

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

stool collection

Intervention Type OTHER

Stool will be collected from participants at study entry

Interventions

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Colonoscopy biopsy

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

Intervention Type PROCEDURE

stool collection

Stool will be collected from participants at study entry

Intervention Type OTHER

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

Intervention Type PROCEDURE

stool collection

stool will be collected from participants 2 times during study - at active phase and inactive phase

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Food and Drug Safety, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Joo Sung Kim, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Joo Sung Kim, M.D., PhD

Role: CONTACT

+82-2-740-8112

Seong-Joon Koh, M.D.

Role: CONTACT

+82-2-740-8112

Facility Contacts

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Joo Sung Kim, Ph.D

Role: primary

82-2-740-8112

Seong-Joon Koh

Role: backup

82-2-740-8112

Other Identifiers

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Gut Microbiome in UC Patients

Identifier Type: -

Identifier Source: org_study_id

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