Gut Microbiota Pilot Study

• Sponsor: Armed Forces Goyang Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03892590
• Collaborator: (none)
• Enrollment: 40
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Microbiota; Metabolism	Biological: Gut microbiota

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Anaylsis of Gut Microbiota in ICU
• Anticipated Study Start Date: Apr 1, 2019
• Anticipated Primary Completion Date: Feb 28, 2020
• Anticipated Study Completion Date: Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Stable patient Stable patients who admitted to ICU for observation.	Biological: Gut microbiota; Status of microbiota

Outcome Measures

Primary Outcome Measures

1. Normal microbiota [1day]

   Status of microbiota of stable patient in ICU

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Armed Forces Goyang Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maru Kim, Dr., The Catholic University of Korea
• ClinicalTrials.gov Identifier: NCT03892590
• Other Study ID Numbers: Gut Microbiota
• First Posted: Mar 27, 2019
• Last Update Posted: Mar 27, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 27, 2019