NCT03892590

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

35
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

Shorter than P25 for all trials

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 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

March 26, 2019

Last Update Submit

March 26, 2019

Conditions

MicrobiotaMetabolism

Outcome Measures

Primary Outcomes (1)

  • Normal microbiota

    Status of microbiota of stable patient in ICU

    1day

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool

MeSH Terms

Interventions

Gastrointestinal Microbiome

Intervention Hierarchy (Ancestors)

MicrobiotaMicrobiological PhenomenaBiotaBiodiversityEcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Officials

  • Maru Kim, MD, PhD

    The Catholic University of Korea

    STUDY CHAIR

Central Study Contacts

M Kim, MD, PhD

CONTACT

82318266246maru@catholic.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 26, 2019

First Posted

March 27, 2019

Study Start

April 1, 2019

Primary Completion

February 28, 2020

Study Completion

March 31, 2020

Last Updated

March 27, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share