NCT03897023

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

April 15, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

2.2 years

First QC Date

March 28, 2019

Last Update Submit

March 30, 2021

Conditions

MicrobiotaMetabolism

Outcome Measures

Primary Outcomes (1)

  • Stuatus of gut microbiota in stable patient

    Result of next generation sequencing

    1 Month

Study Arms (1)

Stable patient

Stable patients who admitted to ICU for observation.

Biological: Gut Microbiota

Interventions

Gut MicrobiotaBIOLOGICAL

Status of microbiota

Stable patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stable adult patient who are admitted to ICU

You may qualify if:

  • Older than 17 years old
  • Every patients who are admitted to ICU

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uijeongbu St.Mary's hospital

Uijeongbu-si, Gyeonggi-do, 11765, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool

MeSH Terms

Interventions

Gastrointestinal Microbiome

Intervention Hierarchy (Ancestors)

MicrobiotaMicrobiological PhenomenaBiotaBiodiversityEcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Central Study Contacts

Maru Kim, MD., Ph.D.

CONTACT

82318205266maru@catholic.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 28, 2019

First Posted

April 1, 2019

Study Start

April 15, 2019

Primary Completion

June 27, 2021

Study Completion

June 27, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)