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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

Sepsis, Trauma InjurySepsis; Trauma; Microbiome

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

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1 of 468 participants interested
0% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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Study locations

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RECRUITING

Gainesville

Florida

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

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Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Sepsis, Trauma Injury Treatment Options in Gainesville, Florida

If you're searching for Sepsis, Trauma Injury treatment in Gainesville, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Gainesville and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Sepsis, Trauma Injury. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Florida
Now Enrolling
Up to 468 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Sepsis, Trauma Injury?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Sepsis, Trauma Injury

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Sepsis, Trauma Injury Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05357170. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.