Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Seoul National University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Seoul National University Hospital
Collaborator:
Korea Food and Drug Administration
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01010815
First received: November 8, 2009
Last updated: November 9, 2009
Last verified: November 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ulcerative Colitis |
Procedure: Colonoscopy biopsy Other: stool collection Procedure: colonoscopy biopsy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- characterize the difference in gut microbiomes through metagenomic analysis between UC patients and normal control subjects [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- characterize the difference in gut microbiomes among colonoscopy biopsy locations (rectum, ascending and descending colon) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- characterize the difference in gut microbiomes between active and inactive UC patients [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
Participants will need to give stool samples and colorectal biopsy specimens on 1 or 2 separate occasions
| Estimated Enrollment: | 15 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
UC group
clinically and microscopically confirmed UC patients between the age of 19 and 75 years
|
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
|
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
|
Eligibility| Ages Eligible for Study: | 19 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
gastroenterology clinic at SNUH(Seoul National University Hospital)
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010815
Contacts
| Contact: Joo Sung Kim, M.D., PhD | +82-2-740-8112 | jooskim@snu.ac.kr |
| Contact: Seong-Joon Koh, M.D. | +82-2-740-8112 | jel1206@medimail.co.kr |
Locations
| Korea, Republic of | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Joo Sung Kim, Ph.D 82-2-740-8112 jooskim@snu.ac.kr | |
| Contact: Seong-Joon Koh 82-2-740-8112 jel1206@medimail.co.kr | |
Sponsors and Collaborators
Seoul National University Hospital
Korea Food and Drug Administration
Investigators
| Principal Investigator: | Joo Sung Kim, M.D., PhD | Seoul National University Hospital |
More Information
No publications provided
| Responsible Party: | Joo Sung Kim, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01010815 History of Changes |
| Other Study ID Numbers: | Gut Microbiome in UC Patients |
| Study First Received: | November 8, 2009 |
| Last Updated: | November 9, 2009 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Seoul National University Hospital:
|
ulcerative colitis gut microbiome metagenomics |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Inflammatory Bowel Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013