Gut Microbiome Dysfunction in Sepsis Survivors
Study Details
Study Description
Brief Summary
Gastrointestinal microbiome dysfunction has been demonstrated to be a culprit of various systemic dysfunctions in peripheries such as cardiovascular, nervous, endocrine and musculoskeletal systems. The topic of microbiome dysfunction after sepsis is understudied but may be responsible for persistent systemic inflammation clinically observed in sepsis survivors. Therefore, the objective of this project is to investigate the gut microbiome after acute phase of sepsis and compare it with 108 age-matched healthy population controls
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The investigators hypothesize that alterations of the gut microbiota will correlate with persistent systemic inflammation in sepsis survivors compared to existing healthy population controls.
This research group will collect stool samples from 108 sepsis survivors (groups of ages 18-45, 46-64, and >65; male and female; n=18 per age + sex cohort) admitted to the surgical intensive care unit between day 7 and 28 of hospital admission, as well as 3 and 6 months after their sepsis event. The investigators will perform 16S rRNA DNA sequencing on the isolated bacterial DNA from these samples and bioinformatic analysis to determine microbiota alterations between time points and between sepsis and control cohorts. In addition, the investigators will draw 20ml of blood to isolate plasma. The specific aims will be: Aim 1 - define the impact of persistent systemic inflammation on the gastrointestinal microbiota in sepsis survivors and Aim 2 - identify microbial genes associated with persistent systemic inflammation in sepsis survivors compared to normal controls.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sepsis Survivors Feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Blood will be collected at time of first feces collection |
Other: Human feces collection
Human feces collection and blood sampling
Other Names:
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| Healthy Control Population One time collection of feces and blood upon enrollment used for comparison to identify microbial genes associated with persistent systemic inflammation in sepsis survivors. |
Other: Human feces collection
Human feces collection and blood sampling
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Determine the impact of persistent systematic inflammation on gastrointestinal microbiota in sepsis survivors and identify microbial genes associated with persistent systemic inflammation of sepsis survivors compared to normal controls. [through study completion, an average of 6 months]
Identify gut microbiome dysfunction through Microbial Taxonomic Analysis and Meta-transcriptomic Analysis
Eligibility Criteria
Criteria
Sepsis Population
Inclusion Criteria
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Admission to the 46, 77, 87, 4 East, 4 West, or 24-5 ICUs where clinical care can be managed by the critical care organization guided by standard operating procedures.
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Age ≥18 years
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Diagnosis sepsis, severe sepsis, or septic shock
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Has remained in ICU for 14 days (+/- 7 days) following sepsis diagnosis.
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Ability to obtain patient/LAR informed consent.
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Is receiving adequate nutritional intake: oral or enteral nutrition.
Exclusion Criteria
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Expected lifespan of the patient is less than 3 months due to severe pre-existing comorbidities (ex. recurrent, advanced or metastatic cancer).
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Severe traumatic brain injury which requires intracranial pressure monitoring via intraventricular catheter or subdural bolt with sensor wire.
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Refractory shock (i.e., patients who are expected to die within 12 hours).
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Uncontrollable source of sepsis (e.g. irreversible disease state such as unresectable dead bowel).
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Patient or patient's family are not committed to aggressive management of the patient's condition.
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Severe CHF (NY Heart Association Class IV).
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Child-Pugh Class C liver disease or pre-liver transplant.
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Known HIV infection with CD4 count <200 cells/mm3.
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Organ transplant recipient on immunosuppressive agents.
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Known pregnancy.
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Prisoners.
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Institutionalized patients
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Inability to obtain informed consent.
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Chemotherapy or radiotherapy within 30 days prior to sepsis.
Healthy Control
Inclusion criteria will be:
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All adults (age ≥18)
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Ability to obtain Informed Consent prior to blood collection.
Exclusion Criteria will be:
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Current, chronic steroid use
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Pregnancy
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Current or recent (within 7 days) use of antibiotics.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UF Health at Shands Hospital | Gainesville | Florida | United States | 32610 |
Sponsors and Collaborators
- University of Florida
Investigators
- Principal Investigator: Philip Efron, MD, UF COM Department of Surgery
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB202102863