Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis

Study Overview
=================
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.

Official Title
-----------------
Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Procedure: Colonoscopy biopsy
* Other: stool collection
* Procedure: colonoscopy biopsy
* Other: stool collection


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ulcerative colitis, gut microbiome, metagenomics