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NCT07864818

Sepsis ICU Gut Microbiome Analysis

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

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.

Official title: Sepsis ICU Gut Microbiome Analysis (SIGMA): A Prospective Observational Cohort Study of Gut Microbiota Structure, Functional Metabolic Features, and Composite Biomarkers in Adult ICU Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2026-10-15

Completion Date

2027-12-30

Last Updated

2026-10-08

Healthy Volunteers

Conditions

Sepsis Septic Shock

Interventions

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.

Inclusion Criteria: * 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. * Written informed consent is provided by participants who have decision-making capacity. For participants who temporarily lack decision-making capacity because of impaired consciousness, sedation, or critical illness, consent is provided by a legally authorized representative in accordance with applicable law. Once participants regain decision-making capacity, they will be informed again as soon as possible and asked to provide consent for continued participation. Exclusion Criteria: * 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. * Expected death within 24 hours and inability to complete informed consent and baseline procedures without interfering with emergency care. * Refusal to participate by the participant or their legally authorized representative, or an investigator determination that the participant is unsuitable for enrollment based on safety, adherence, or data validity considerations.

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China