Ulcerative ColitisNCT01010815
Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Colonoscopy biopsy and stool collection
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2009to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: gastroenterology clinic at SNUH(Seoul National University Hospital)
Who may be able to join
- Between the age of 19 and 75 years
- willing to consent/undergo necessary procedures
- clinically active or inactive Ulcerative colitis
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Joo Sung Kim, Ph.D, 82-2-740-8112, jooskim@snu.ac.kr
Seong-Joon Koh, 82-2-740-8112, jel1206@medimail.co.kr
About this study
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Colonoscopy biopsy, stool collection
- Keywords
- ulcerative colitis, gut microbiome, metagenomics
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy biopsyProcedure or surgery
Colonoscopy biopsy will be performed in rectum, ascending and descending colon at study entry
stool collectionOther
Stool will be collected from participants at study entry
colonoscopy biopsyProcedure or surgery
colonoscopy biopsy will be conducted in rectum, ascending and descending colon from participants 2 times during study - at active phase and inactive phase
stool collectionOther
stool will be collected from participants 2 times during study - at active phase and inactive phase
| Study group | Role | What they receive |
|---|---|---|
| UC group | clinically and microscopically confirmed UC patients between the age of 19 and 75 years Receives: Procedure: colonoscopy biopsy; Other: stool collection | |
| Control group | normal healthy controls Receives: Procedure: Colonoscopy biopsy; Other: stool collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
characterize the difference in gut microbiomes through metagenomic analysis between UC patients and normal control subjects
Measured: 1 year
Secondary outcomes (3)
characterize the difference in gut microbiomes through metagenomic analysis between stool specimens and biopsy specimens in participants with UC and normal subjects
Measured: 1 year
characterize the difference in gut microbiomes among colonoscopy biopsy locations (rectum, ascending and descending colon)
Measured: 1 year
characterize the difference in gut microbiomes between active and inactive UC patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2010 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Investigators
- Joo Sung Kim, M.D., PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010815
- Sponsor's protocol ID
- Gut Microbiome in UC Patients
- Status last verified
- Nov 2009
- First submitted
- 8 Nov 2009
- Last updated
- 10 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01010815
- Acronym / sponsor ID
- Gut Microbiome in UC Patients
- Conditions
- Ulcerative Colitis
- Keywords
- ulcerative colitis, gut microbiome, metagenomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC group | – | Procedure: colonoscopy biopsy, Other: stool collectionclinically and microscopically confirmed UC patients between the age of 19 and 75 years |
| Control group | – | Procedure: Colonoscopy biopsy, Other: stool collectionnormal healthy controls |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- gastroenterology clinic at SNUH(Seoul National University Hospital)
Key inclusion criteria (3 listed)
- Between the age of 19 and 75 years
- willing to consent/undergo necessary procedures
- clinically active or inactive Ulcerative colitis
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonoscopy biopsyColonoscopy biopsy will be performed in rectum, ascending and descending colon at study entry | Procedure or surgery | Control group |
| stool collectionStool will be collected from participants at study entry | Other | Control group |
| colonoscopy biopsycolonoscopy biopsy will be conducted in rectum, ascending and descending colon from participants 2 times during study - at active phase and inactive phase | Procedure or surgery | UC group |
| stool collectionstool will be collected from participants 2 times during study - at active phase and inactive phase | Other | UC group |
Primary outcome
characterize the difference in gut microbiomes through metagenomic analysis between UC patients and normal control subjects
Time frame: 1 year
3 secondary outcomes
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
characterize the difference in gut microbiomes among colonoscopy biopsy locations (rectum, ascending and descending colon)
Time frame: 1 year
characterize the difference in gut microbiomes between active and inactive UC patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo Sung Kim, M.D., PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joo Sung Kim, M.D., PhD (+82-2-740-8112, jooskim@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characterize the difference in gut microbiomes through metagenomic analysis between UC patients and normal control subjects (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2009.