Sepsis, Trauma InjuryNCT05357170
Microbiome Dysfunction in Surgical Intensive Care Unit Survivors
An observational study of Sepsis, Trauma Injury, run by University of Florida at 1 site in United States.
Trial summary
Oral and gastrointestinal microbiome dysfunction has been demonstrated to be a culprit of various systemic dysfunctions in peripheries such as cardiovascular, nervous, endocrine and musculoskeletal systems. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Trauma Injury
- What is being tested?
- Human feces collection
- Type of treatment
- Pill or oral medicine
- How many people
- 468 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2022to 31 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted to surgical intensive care units who screen positive for sepsis, have severe trauma injury, undergo cardiopulmonary bypass or major vascular surger and are being treated by our standard-of care ICU protocols are candidates for the study. Healthy adult volunteers will provide reference control samples.
Who may be able to join
- 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.
- Age ≥18 years
- Meets Sepsis 3 criteria at time of sepsis diagnosis
- Has remained in ICU for 14 days (+/- 7 days) following sepsis diagnosis.
- Ability to obtain patient/LAR informed consent.
- Is receiving adequate nutritional intake: oral or enteral nutrition.
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- 1. All adults (age ≥18 to 54) require both:
- Blunt and/or penetrating trauma patient with i. Hemorrhagic shock defined by:
- 1. Systolic BP (SBP) ≤ 90 mmHg or 2. Mean arterial pressure ≤ 65 mmHg or 3. Base deficit (BD) ≥5 meq or 4. Lactate ≥ 2 or 5. Active red blood cell or whole blood transfusion within 6 hours of arrival
- Injury Severity Score (ISS) greater than or equal to 15
- 2. All adults (age 55 and older) require:
- Either hemorrhagic shock defined by: i. Systolic BP (SBP) ≤ 90 mmHg or ii. Mean arterial pressure ≤ 65 mmHg or iii. Base deficit (BD) ≥5 meq or iv. Lactate ≥ 2 or v. Active red blood cell or whole blood transfusion within 6 hours of arrival
- OR
- Injury Severity Score (ISS) greater than or equal to 15. 3. Ability to obtain Informed Consent
- 1. Any adult age 18 or older with any traumatic bleed (intracerebral hemorrhage, subarachnoid hemorrhage, intraparenchymal hemorrhage, subdural hematoma, cerebral epidural hematoma) and any GCS (Glasgow Coma Score).
- Adult (>18 years age) patients undergoing open cardiac surgery
- Ability to obtain patient informed consent
- was placed on cardiopulmonary bypass at their initial operation at UF Health
- Adult (>18 years age) patients undergoing open abdominal vascular surgery
- Ability to obtain patient informed consent,
- All adults (age ≥18)
- Ability to obtain Informed Consent prior to blood collection.
Who cannot join
- Severe traumatic brain injury with unencumbered assessment of GCS equaling 3 on admission to intensive care unit
- Refractory shock (i.e., patients who are expected to die within 12 hours).
- Uncontrollable source of sepsis (e.g. irreversible disease state such as unresectable dead bowel).
- Patient or patient's family are not committed to aggressive management of the patient's condition.
- Known HIV infection with CD4 count <200 cells/mm3.
- Organ transplant recipient on immunosuppressive agents.
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- Known pregnancy.
- Prisoners.
- Institutionalized patients j Inability to obtain informed consent.
- Burn injury greater than 20% TBSA (total body surface area)
- Trauma Population
- Patients not expected to survive greater than 48 hours.
- Prisoners.
- Pregnancy.
- Previous bone marrow transplantation.
- Patients with End Stage Renal Disease.
- Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers)
- Burn injury greater than 20% TBSA
- Severe traumatic brain injury with unencumbered assessment of GCS equaling 3 on admission to intensive care unit.
- Trauma TBI subgroup (15 participants)
- Cardiac-Surgery operation:
- Inability to obtain informed consent,
- Pregnancy
- Evidence of multi-organ failure on presentation
- Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers
- Prisoners
- Previous bone marrow transplantation
- Burn injury greater than 20% TBSA
- Open abdominal vascular operation:
- Inability to obtain informed consent,
- Pregnancy
- Evidence of multi-organ failure on presentation
- Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers
- Prisoners
- Previous bone marrow transplantation.
- Burn injury greater than 20% TBSA
- Healthy Control
- Current, chronic steroid use
- Pregnancy
- Current or recent (within 7 days) use of antibiotics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UF Health at Shands Hospital
Gainesville, Florida, 32610
Ruth Davis, BSN, 352-273-8759, ruth.davis@surgery.ufl.edu
Jennifer Lanz, MSN, 352-273-5497
About this study
Official title: Microbiome Dysfunction in Surgical Intensive Care Unit Survivors Subtitle: The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma Pathological Myeloid Activation After Sepsis and Trauma
Oral and 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 surgical intensive care admission is understudied but may be responsible for persistent systemic inflammation clinically observed in surgical intensive care patients. Therefore, the objective of this project is to investigate the oral and gut microbiome after the acute phase of sepsis, severe trauma injury, cardiopulmonary bypass, and major vascular surgery to compare with 108 age-matched healthy population controls
Read the detailed description
The investigators hypothesize that alterations of the oral and gut microbiota will correlate with persistent systemic inflammation in surgical intensive care unit survivors compared to existing healthy population controls. This research group will collect oral and stool samples from 108 sepsis survivors, 108 trauma survivors, 108 cardiopulmonary bypass survivors, and major vascular surgery 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 intensive care unit hospitalization. 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 surgical ICU survivor cohorts and a control cohort. In addition, the investigators will draw 20ml of blood to isolate plasma.
Trauma Subgroup for traumatic brain injury (TBI) pilot study: Our team will enroll 15 additional trauma injury patients with traumatic brain injury. This subgroup will have an added stool (if available) and blood sample collection after initial injury (+ 5 days). The additional sample will be compared to the sample collected at 14-21 days and follow up samples at 3 and 6 months. The results will be associated with Glasgow Outcome Scale Extended at 3 and 12 month time points and the recorded discharge Rancho Los Amigos scale score from the medical record. The specific aims will be: Aim 1 - define the impact of persistent systemic inflammation on the gastrointestinal microbiota in sepsis and trauma survivors and Aim 2 - identify microbial genes associated with persistent systemic inflammation in sepsis and trauma survivors compared to normal controls. Trauma Subgroup Aim: Pilot study to test the hypothesis that changes in the microbiome towards pathogenic microbe is associated with worsened outcomes in trauma injury patients with TBI (traumatic brain injury).
- Conditions
- Sepsis, Trauma Injury
- Being tested
- Human feces collection
- Keywords
- Sepsis; Trauma; Microbiome
- Medical subject headings
- Sepsis, Accidental Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human feces collectionOther
Also called Blood sampling, Oral swab and saliva
Oral swab and saliva, human feces collection and blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Sepsis Survivors | Oral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months.
Blood will be collected at time of first feces collection Receives: Other: Human feces collection | |
| Healthy Control Population | One time collection of oral swab and saliva, feces, and blood upon enrollment used for comparison to identify microbial genes associated with persistent systemic inflammation in sepsis survivors. Receives: Other: Human feces collection | |
| Trauma Survivor | Oral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months.
Blood will be collected at time of first feces collection Receives: Other: Human feces collection | |
| Traumatic Brain Injury (TBI) | Oral swab, saliva, and feces collected at admission (day 1(+5)) and between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months.
Blood will be collected at time of first and second feces collection. Receives: Other: Human feces collection | |
| Cardiopulmonary Bypass | Oral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months.
Blood will be collected at time of first feces collection Receives: Other: Human feces collection | |
| Major Vascular Surgery | Oral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months.
Blood will be collected at time of first feces collection Receives: Other: Human feces collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the impact of persistent systemic inflammation on oral and gastrointestinal microbiota in surgical ICU survivors & identify microbial genes associated with persistent systemic inflammation of surgical ICU survivors compared to normal controls.
Identify oral and gut microbiome dysfunction through Microbial Taxonomic Analysis and Meta-transcriptomic Analysis
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start21 Jun 2022
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis, Trauma InjuryStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Philip Efron, MD, Principal investigator, UF COM Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357170
- Sponsor's protocol ID
- IRB202102863
- Other IDs
- R35GM140806
- Status last verified
- Jul 2026
- First submitted
- 12 Apr 2022
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Dysfunction in Surgical Intensive Care Unit Survivors Subtitle: The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma Pathological Myeloid Activation After Sepsis and Trauma
- ClinicalTrials.gov ID
- NCT05357170
- Acronym / sponsor ID
- IRB202102863
- Conditions
- Sepsis, Trauma Injury
- Keywords
- Sepsis; Trauma; Microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 2 May 2022 (actual)
- 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.
Oral and 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 surgical intensive care admission is understudied but may be responsible for persistent systemic inflammation clinically observed in surgical intensive care patients. Therefore, the objective of this project is to investigate the oral and gut microbiome after the acute phase of sepsis, severe trauma injury, cardiopulmonary bypass, and major vascular surgery to compare with 108 age-matched healthy population controls
Detailed description
The investigators hypothesize that alterations of the oral and gut microbiota will correlate with persistent systemic inflammation in surgical intensive care unit survivors compared to existing healthy population controls. This research group will collect oral and stool samples from 108 sepsis survivors, 108 trauma survivors, 108 cardiopulmonary bypass survivors, and major vascular surgery 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 intensive care unit hospitalization. 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 surgical ICU survivor cohorts and a control cohort. In addition, the investigators will draw 20ml of blood to isolate plasma.
Trauma Subgroup for traumatic brain injury (TBI) pilot study: Our team will enroll 15 additional trauma injury patients with traumatic brain injury. This subgroup will have an added stool (if available) and blood sample collection after initial injury (+ 5 days). The additional sample will be compared to the sample collected at 14-21 days and follow up samples at 3 and 6 months. The results will be associated with Glasgow Outcome Scale Extended at 3 and 12 month time points and the recorded discharge Rancho Los Amigos scale score from the medical record. The specific aims will be: Aim 1 - define the impact of persistent systemic inflammation on the gastrointestinal microbiota in sepsis and trauma survivors and Aim 2 - identify microbial genes associated with persistent systemic inflammation in sepsis and trauma survivors compared to normal controls. Trauma Subgroup Aim: Pilot study to test the hypothesis that changes in the microbiome towards pathogenic microbe is associated with worsened outcomes in trauma injury patients with TBI (traumatic brain injury).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sepsis Survivors | – | Other: Human feces collectionOral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first feces collection |
| Healthy Control Population | – | Other: Human feces collectionOne time collection of oral swab and saliva, feces, and blood upon enrollment used for comparison to identify microbial genes associated with persistent systemic inflammation in sepsis survivors. |
| Trauma Survivor | – | Other: Human feces collectionOral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first feces collection |
| Traumatic Brain Injury (TBI) | – | Other: Human feces collectionOral swab, saliva, and feces collected at admission (day 1(+5)) and between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first and second feces collection. |
| Cardiopulmonary Bypass | – | Other: Human feces collectionOral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first feces collection |
| Major Vascular Surgery | – | Other: Human feces collectionOral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first feces collection |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to surgical intensive care units who screen positive for sepsis, have severe trauma injury, undergo cardiopulmonary bypass or major vascular surger and are being treated by our standard-of care ICU protocols are candidates for the study. Healthy adult volunteers will provide reference control samples.
Key inclusion criteria (22 listed)
- 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.
- Age ≥18 years
- Meets Sepsis 3 criteria at time of sepsis diagnosis
- Has remained in ICU for 14 days (+/- 7 days) following sepsis diagnosis.
- Ability to obtain patient/LAR informed consent.
Key exclusion criteria (40 listed)
- Severe traumatic brain injury with unencumbered assessment of GCS equaling 3 on admission to intensive care unit
- Refractory shock (i.e., patients who are expected to die within 12 hours).
- Uncontrollable source of sepsis (e.g. irreversible disease state such as unresectable dead bowel).
- Patient or patient's family are not committed to aggressive management of the patient's condition.
- Known HIV infection with CD4 count <200 cells/mm3.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human feces collectionAlso: Blood sampling, Oral swab and salivaOral swab and saliva, human feces collection and blood sampling | Other | Cardiopulmonary Bypass, Healthy Control Population, Major Vascular Surgery, Sepsis Survivors, Trauma Survivor, Traumatic Brain Injury (TBI) |
Primary outcome
Determine the impact of persistent systemic inflammation on oral and gastrointestinal microbiota in surgical ICU survivors & identify microbial genes associated with persistent systemic inflammation of surgical ICU survivors compared to normal controls.
Time frame: through study completion, an average of 6 months
Identify oral and gut microbiome dysfunction through Microbial Taxonomic Analysis and Meta-transcriptomic Analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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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.
Philip Efron, MD principal investigator
UF COM Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, Trauma Injury, run by University of Florida at 1 site in United States.
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 22 inclusion and 40 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruth Davis, BSN (352-273-8759, ruth.davis@surgery.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the impact of persistent systemic inflammation on oral and gastrointestinal microbiota in surgical ICU survivors & identify microbial genes associated with persistent systemic inflammation of surgical ICU survivors compared to normal controls. (time frame: through study completion, an average of 6 months). 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 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.