Gut Microbiota Pilot Study

March 26, 2019 updated by: Maru Kim, Armed Forces Goyang Hospital

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

Unknown

Conditions

Intervention / Treatment

Detailed Description

Microbiota is known to effect metabolism. Patients in specific conditions like hypovolemic shock, sepsis might have changes in status of microbiota. This is pilot study to get status of microbiota from normal control. Stable patient who are admitted to ICU for observation will be gathered. Samples will be collected via rectal swab at time of admission and analyzed via Next generation sequencing.

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.

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.
Biological: Gut microbiota
Status of microbiota

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normal microbiota
Time Frame: 1day
Status of microbiota of stable patient in ICU
1day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Forces Goyang Hospital

Investigators

  • Study Chair: Maru Kim, MD, PhD, The Catholic University of Korea

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 (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

February 28, 2020

Study Completion (Anticipated)

March 31, 2020

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

March 27, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Gut Microbiota

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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