NCT02768324

Brief Summary

Sepsis is a life-threatening condition that arises when the body's response to infection injures its own tissues and organs. Common signs and symptoms include fever, increased heart rate, increased breathing rate, and confusion. Clinically, sepsis patients with diarrhea often result in a bad prognosis. Gut microbiota consists of a complex community of microorganisms that live in the digestive tracts of animals. The gut microbiota comprises the largest and most diverse reservoir of mutualistic microorganisms associated with animals. The aims of this study is to determin the effect of gut microbiota on the prognosis of Sepsis, by using 16s pyrosequencing, comparing the blood culture result.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1.6 years

First QC Date

May 10, 2016

Last Update Submit

March 7, 2017

Conditions

Sepsis

Keywords

sepsisGastrointestinal MicrobiomeGut microbiotaGut FloraIntestinal Flora

Outcome Measures

Primary Outcomes (1)

  • Discharged from ICU

    7 days

Study Arms (2)

sepsis with diarrhea

sepsis without diarrhea

Eligibility Criteria

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

patients with sepsis were included in this study

You may qualify if:

  • Subjects diagnosed with sepsis
  • years to 65 years of age

You may not qualify if:

  • patients had complications such as acute cerebral infarction or acute myocardial infarction
  • The use of antibiotics, pro-prebiotics within 3 months
  • \<18 years or \>65 years
  • History of intestinal surgery
  • patients withdraw from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Li Deng, PhD

CONTACT

0086-18819351723

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. student

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 11, 2016

Study Start

May 1, 2017

Primary Completion

December 1, 2018

Study Completion

September 1, 2019

Last Updated

March 9, 2017

Record last verified: 2017-03