An observational study in Sepsis and Septic Shock, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Observational
Sepsis is a life-threatening condition in which the body's response to an infection damages its own organs. This study aims to understand how the bacteria living in the gut change during sepsis and whether patterns of gut bacteria and chemicals found in stool can help identify patients at greater risk of death or poor recovery.
This observational study plans to enroll approximately 180 adults with sepsis receiving care in the intensive care unit (ICU) at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. All participants will receive usual medical care. The study will not assign experimental treatments or change treatment decisions.
Researchers will collect stool samples or, when stool is unavailable and sampling is safe, rectal swabs. Samples will be collected within the first 48 hours of the study, on days 3-5, on day 7, and near ICU discharge when feasible. Researchers will examine the types and amounts of gut bacteria. Samples from a selected group of participants will also be tested for chemicals related to metabolism. Information about illness severity, medicines, nutrition, and organ support will be collected from medical records.
Participants will be followed for 90 days, using medical records and telephone follow-up. The main clinical outcome is death from any cause within 28 days. Other outcomes include death and unplanned hospital readmission within 90 days. Researchers will assess whether gut bacterial patterns add useful information to routine clinical assessments and compare findings with available data from other sepsis studies.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 180 is above the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 162 studies on the registry; 131 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults aged 18 years or older receiving care in the ICU at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, who meet the Sepsis-3 definition: suspected or confirmed infection with an acute infection-related increase in SOFA score of at least 2 points from baseline. Patients with or without septic shock will be consecutively enrolled. Eligible patients must be able to provide a spontaneously passed stool sample or undergo safe rectal swab collection within the baseline sampling window of 48 hours after T0. Written informed consent will be obtained from the patient or a legally authorized representative.
Exclusion Criteria:
Other: Naturally Occurring Exposures
No study-directed intervention is assigned. All participants receive usual care as determined by their treating clinicians. Antibiotic use, other medications, nutrition, and organ support are recorded as naturally occurring exposures. Stool or rectal swab samples are collected at predefined time points to assess gut microbiota, with metabolite testing performed in a selected subgroup. These assessments are for research purposes and do not guide treatment decisions. Participants are followed for 90 days to assess survival and hospital readmission.
Number of Bacterial Taxonomic Units Included in the Locked Gut Microbiota Signature
Number of distinct bacterial taxonomic units included in the final locked gut microbiota signature, with a prespecified minimum of 15 units. Taxonomic units are represented by amplicon sequence variants (ASVs) or operational taxonomic units (OTUs) derived from 16S rRNA gene sequencing. The constituent units and their directions of association will be fixed after feature selection and internal validation.
Time frame: Baseline (0-48 hours), days 3-5, day 7, and before ICU transfer or death, when feasible; outcomes through day 28
Change in Gut Microbiota Alpha Diversity Across Serial ICU Samples
Within-participant changes in gut microbiota alpha diversity derived from 16S rRNA gene sequencing across the prespecified sampling time points. Alpha diversity describes the diversity of bacterial taxonomic units within an individual sample.
Time frame: Baseline (0-48 hours), days 3-5, day 7, and before ICU transfer or death, when feasible
Between-Sample Differences in Gut Microbiota Composition Across Serial ICU Samples
Differences in bacterial community composition between samples, measured using beta diversity metrics derived from 16S rRNA gene sequencing. Both within-participant changes over time and between-participant differences will be assessed.
Time frame: Baseline (0-48 hours), days 3-5, day 7, and before ICU transfer or death, when feasible
Change in Relative Abundance of Gut Bacterial Taxonomic Units Across Serial ICU Samples
Within-participant changes in the relative abundance of bacterial ASVs or OTUs across sampling time points. Associations with illness severity, antibiotic exposure, nutrition, and organ support will be assessed using methods appropriate for compositional microbiome data.
Time frame: Baseline (0-48 hours), days 3-5, day 7, and before ICU transfer or death, when feasible
Change in Measured Metabolite Abundance Across Serial ICU Samples
Within-participant changes in metabolite abundance measured by untargeted liquid chromatography-mass spectrometry in the prespecified nested metabolomics subgroup with qualified paired samples. Associations with gut microbiota features and organ dysfunction will be assessed. Measured metabolites will be distinguished from functions inferred from 16S sequencing.
Time frame: Baseline (0-48 hours), days 3-5, day 7, and before ICU transfer or death, when feasible
Change in AUROC After Adding the Gut Microbiota Signature to the Clinical Model for 28-Day Death or Persistent Organ Dysfunction
Difference in the area under the receiver operating characteristic curve (AUROC) between a prespecified clinical model and the same model incorporating the locked gut microbiota signature for predicting 28-day death or persistent organ dysfunction. Performance will be assessed using patient-level nested cross-validation.
Time frame: From T0 through day 28
Change in Brier Score After Adding the Gut Microbiota Signature to the Clinical Model for 28-Day Death or Persistent Organ Dysfunction
Difference in Brier score between a prespecified clinical model and the same model incorporating the locked gut microbiota signature for predicting 28-day death or persistent organ dysfunction. Lower Brier scores indicate better prediction accuracy. Performance will be assessed using patient-level nested cross-validation.
Time frame: From T0 through day 28
Adjusted Association Between the Gut Microbiota Signature and 90-Day All-Cause Mortality
Association between the locked gut microbiota signature and death from any cause within 90 days, adjusted for prespecified clinical confounders. The estimated association and its 95% confidence interval will be reported. Survival status will be determined from medical records and telephone follow-up.
Time frame: From T0 through day 90
Adjusted Association Between the Gut Microbiota Signature and First Unplanned Hospital Readmission Within 90 Days
Association between the locked gut microbiota signature and the first unplanned hospital readmission among participants discharged alive, adjusted for prespecified clinical confounders. Planned admissions and transfers for continuous treatment are excluded. Death will be treated as a competing event.
Time frame: From index hospital discharge through day 90 after T0
AUROC of the Locked Gut Microbiota Signature in External Adult Sepsis Cohorts
Area under the receiver operating characteristic curve of the locked gut microbiota signature in eligible external adult sepsis cohorts with comparable microbiome features and clinical outcomes. External validation will be conducted after signature locking. Healthy reference datasets will be used only to characterize background variation.
Time frame: Through day 28 in external cohorts with compatible outcomes
Number of Candidate Bacterial Taxa Assigned to Each Priority Tier
Number of candidate bacterial taxa assigned to each priority tier based on feature selection stability, cross-cohort reproducibility, associations with clinical outcomes, and supporting functional and metabolic evidence. Prioritized taxa will be identified for subsequent strain-level and mechanistic validation.
Time frame: Serial ICU samples and clinical outcomes through day 9
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology