Gut Microbiota Pilot Study

Microbiota Clinical Trial

Official title:

Anaylsis of Gut Microbiota in ICU

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03892590
• Other study ID #: Gut Microbiota
• Status: Not yet recruiting
• Start date: April 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2019
• Source: Armed Forces Goyang Hospital
• Contact: M Kim, MD, PhD
• Phone: 82318266246
• Email: maru[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 31, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolism
• Microbiota

Intervention

Biological:
• Gut microbiota
Status of microbiota

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Armed Forces Goyang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal microbiota	Status of microbiota of stable patient in ICU	1day