Gut microbes and blood signals in sepsis-related liver and kidney injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter longitudinal observational study enrolling adults with sepsis across eight ICUs at six medical centers, plus healthy volunteers. For sepsis patients, stool and blood samples are collected at multiple time points to examine gut microbiome diversity, microbial metabolites, intestinal barrier function, and systemic inflammation. Healthy volunteers provide a baseline sample to help interpret patient data. The goal is to better understand how the gut-liver-kidney axis relates to SALI and S-AKI in sepsis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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For Sepsis Patients:

1. Age ≥ 18 years；
2. Admitted to the Intensive Care Unit (ICU) and meets the Sepsis-3 diagnostic criteria (an acute change in total Sequential Organ Failure Assessment \[SOFA\] score ≥ 2 points consequent to the infection).
3. Diagnosed with sepsis within 24 hours prior to enrollment.
4. Informed consent signed by the patient or a legally authorized representative.

For Healthy Volunteers:

1. Age ≥ 18 years.
2. No chronic underlying diseases (including liver, kidney, gastrointestinal, or immune-related disorders).
3. No use of antibiotics or probiotics, and no history of acute infection within 1 month prior to enrollment (to ensure baseline consistency).
4. Informed consent signed by the volunteer.

Exclusion Criteria:

1. History of chronic liver disease (e.g., cirrhosis, chronic hepatitis B/C, autoimmune hepatitis, hepatic carcinoma).
2. History of chronic kidney disease (e.g., glomerulonephritis, IgA nephropathy).
3. History of inflammatory bowel disease (including ulcerative colitis and Crohn's disease) or previous major intestinal resection.
4. Patients with malignant tumors currently receiving chemotherapy or radiotherapy.
5. Expected survival time of less than 72 hours.
6. Pregnant or lactating women.
7. Concurrent participation in other interventional clinical trials.

Where it's running

• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• Lin'an Traditional Chinese Medicine Hospital
  Hangzhou, Zhejiang, China Recruiting
• The Second Affiliated Hospital of Jiaxing University
  Jiaxing, Zhejiang, China Recruiting
• Ningbo Medical Center Lihuili Hospital
  Ningbo, Zhejiang, China Recruiting
• Enze Hospital, Taizhou Enze Medical Center (Group)
  Taizhou, Zhejiang, China Recruiting
• Taizhou Hospital of Zhejiang Province
  Taizhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Wenqiao Yu, PhD
• Email: yuwenqiao1980@zju.edu.cn
• Phone: +86-18868787588

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.