NCT05357170 · University of Florida
Microbiome Dysfunction in Surgical Intensive Care Unit Survivors
What this study is about
taken by mouth 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.
View original scientific description
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.
Interventions
OTHER
Human feces collection
Oral swab and saliva, human feces collection and blood sampling
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Known pregnancy.
- Institutionalized patients j Inability to obtain informed consent. k) Burn injury greater than 20% TBSA (total body surface area) Trauma Population Inclusion Criteria 1\. All adults (age ≥18 to 54) require both: a. 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 b. Injury Severity Score (ISS) greater than or equal to 15 2\. All adults (age 55 and older) require: a. 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 b. Injury Severity Score (ISS) greater than or equal to 15. 3. Ability to obtain Informed Consent Exclusion Criteria
- Patients not expected to survive greater than 48 hours.
- 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) Inclusion criteria will be: 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). Exclusion criteria is the same used for the trauma cohort. Cardiac-Surgery operation: Inclusion Criteria:
- 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 Exclusion Criteria:
- Inability to obtain informed consent,
- Evidence of multi-organ failure on presentation
- Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers
- Previous bone marrow transplantation
- Burn injury greater than 20% TBSA Open abdominal vascular operation: Inclusion Criteria:
- Adult (\>18 years age) patients undergoing open abdominal vascular surgery
- Ability to obtain patient informed consent, Exclusion Criteria:
- Inability to obtain informed consent,
- Evidence of multi-organ failure on presentation
- Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers
- Previous bone marrow transplantation.
- Burn injury greater than 20% TBSA Healthy Control Inclusion criteria will be:
- All adults (age ≥18)
- Ability to obtain Informed Consent prior to blood collection. Exclusion Criteria will be:
- Current, chronic steroid use
- Current or recent (within 7 days) use of antibiotics.
Where
- Gainesville, Florida
Collaborators
National Institute of General Medical Sciences (NIGMS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations