SepsisNCT02768324
the Effect of Gut Microbiota on the Prognosis of Sepsis
An observational study of Sepsis, run by Jinan University Guangzhou.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sepsis
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with sepsis were included in this study
Who may be able to join
- Subjects diagnosed with sepsis
- 18 years to 65 years of age
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Li Deng, PhD contact
About this study
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.
- Conditions
- Sepsis
- Keywords
- sepsis, Gastrointestinal Microbiome, Gut microbiota, Gut Flora, Intestinal Flora
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sepsis with diarrhea | Not described | |
| sepsis without diarrhea | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharged from ICU
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start1 May 2017 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinan University Guangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deng Li, Jinan University Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768324
- Sponsor's protocol ID
- 13123412341
- Status last verified
- Mar 2017
- First submitted
- 10 May 2016
- Last updated
- 9 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Gut Microbiota on the Prognosis of Sepsis
- ClinicalTrials.gov ID
- NCT02768324
- Acronym / sponsor ID
- 13123412341
- Conditions
- Sepsis
- Keywords
- sepsis, Gastrointestinal Microbiome, Gut microbiota, Gut Flora, Intestinal Flora
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jinan University GuangzhouUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sepsis with diarrhea | – | – |
| sepsis without diarrhea | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with sepsis were included in this study
Key inclusion criteria (2 listed)
- Subjects diagnosed with sepsis
- 18 years to 65 years of age
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Discharged from ICU
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Deng, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Jinan University Guangzhou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Deng, PhD (0086-18819351723), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discharged from ICU (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.