Gut Microbiota Pilot Study | NCT03892590

Studies
Gut Microbiota Pilot Study

NCT03892590

Sponsor

Armed Forces Goyang Hospital

Status

Unknown status

Last Update Posted

Mar 27, 2019Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Microbiota
Metabolism

Interventions

Gut microbiota

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Estimated

Primary Completion Date

Feb 28, 2020Estimated

Completion Date

Mar 31, 2020Estimated

First Submitted Date

Mar 26, 2019

First Submission Date that Met QC Criteria

Mar 26, 2019

First Posted Date

Mar 27, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2019

Last Update Posted Date

Mar 27, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stable patient		Stable patients who admitted to ICU for observation.	Biological: Gut microbiota

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gut microbiota	Biological	Status of microbiota	Stable patient

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Stable adult patient who are admitted to ICU

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
M Kim, MD, PhD	Contact	82318266246		maru@catholic.ac.kr

Overall Officials

Name	Affiliation	Role
Maru Kim, MD, PhD	The Catholic University of Korea	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069196	Gastrointestinal Microbiome

Ancestor Terms

ID	Term
D064307	Microbiota
D008827	Microbiological Phenomena
D058448	Biota
D044822	Biodiversity

Browse Leaves

Not provided

Browse Branches

Not provided