- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03897023
Gut Microbiota Pilot Study
March 30, 2021 updated by: Maru Kim, The Catholic University of Korea
Anaylsis of Gut Microbiota in ICU
Microbiota is known to effect metabolism.
This is pilot study to get status of microbiota from normal control.
It will be compared to data from specific patients in ICU via further study.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Microbiota is known to effect metabolism.
This is pilot study to get status of microbiota from normal control.
It will be compared to data from specific patients in ICU via further study.
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maru Kim, MD., Ph.D.
- Phone Number: 82318205266
- Email: maru@catholic.ac.kr
Study Locations
-
-
Gyeonggi-do
-
Uijeongbu-si, Gyeonggi-do, Korea, Republic of, 11765
- Recruiting
- Uijeongbu St.Mary's Hospital
-
Contact:
- Maru Kim
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Stable adult patient who are admitted to ICU
Description
Inclusion Criteria:
- Older than 17 years old
- Every patients who are admitted to ICU
Exclusion Criteria:
- With history of disease such as cancer, Crohn's disease, ulcerative colitis, irritable bowel syndrome
- With history of immunosuppressive agents.
- Initial systolic blood pressure <100
- Initial pulse rate > 100
- Need emergent operation at brain or torso
- Need vasopressor, transfusion
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Stable patient
Stable patients who admitted to ICU for observation.
|
Status of microbiota
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stuatus of gut microbiota in stable patient
Time Frame: 1 Month
|
Result of next generation sequencing
|
1 Month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
April 15, 2019
Primary Completion (Anticipated)
June 27, 2021
Study Completion (Anticipated)
June 27, 2021
Study Registration Dates
First Submitted
March 28, 2019
First Submitted That Met QC Criteria
March 28, 2019
First Posted (Actual)
April 1, 2019
Study Record Updates
Last Update Posted (Actual)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 30, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- GMPS1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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