Sepsis ICU Gut Microbiome Analysis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Receiving care in the ICU at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Suspected or confirmed infection with an acute infection-related increase in the Sequential Organ Failure Assessment (SOFA) score of ≥2 points from baseline, meeting the Sepsis-3 definition.
The research team determines that a spontaneously passed stool sample can be obtained, or a rectal swab can be collected safely, within the permitted baseline sampling window.
Disqualifiers
Pregnancy or reasonable grounds for the investigator to suspect pregnancy.
Active inflammatory bowel disease, major gastrointestinal surgery, or any other condition within the past 3 months that substantially alters intestinal anatomy and affects interpretation of the study results.
Receipt of fecal microbiota transplantation before ICU admission.
Active gastrointestinal bleeding, severe coagulopathy, anorectal surgery or lesions, or other conditions that make rectal swab collection unsafe, together with inability to obtain a spontaneously passed stool sample within the specified sampling window.
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Naturally Occurring Exposures
Other interventionNo 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.
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: Adult ICU Patients With Sepsis1 intervention
Trial outcomes
Primary outcomes
1
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 28Secondary outcomes
1
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 feasible2
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 feasible3
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 feasible4
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 feasibleSponsors and contacts
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Source ClinicalTrials.gov
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