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Gut Microbiota Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897023
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Maru Kim, The Catholic University of Korea

Brief Summary:
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.

Condition or disease Intervention/treatment
Microbiota Metabolism Biological: Gut Microbiota

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anaylsis of Gut Microbiota in ICU
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 31, 2020

Group/Cohort Intervention/treatment
Stable patient
Stable patients who admitted to ICU for observation.
Biological: Gut Microbiota
Status of microbiota




Primary Outcome Measures :
  1. Stuatus of gut microbiota in stable patient [ Time Frame: 1 Month ]
    Result of next generation sequencing


Biospecimen Retention:   Samples Without DNA
Stool


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Stable adult patient who are admitted to ICU
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897023


Contacts
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Contact: Maru Kim, MD., Ph.D. 82318205266 maru@catholic.ac.kr

Locations
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Korea, Republic of
Uijeongbu St.Mary's hospital Recruiting
Uijeongbu-si, Gyeonggi-do, Korea, Republic of, 11765
Contact: Maru Kim         
Sponsors and Collaborators
The Catholic University of Korea

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Responsible Party: Maru Kim, Assistant Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03897023    
Other Study ID Numbers: GMPS1
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No