Gut microbes may hold clues to sepsis organ injury
NCT ID NCT07735182
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This study investigates whether the diversity of gut bacteria is linked to liver and kidney injury in people with sepsis. Researchers will collect stool and blood samples from 200 sepsis patients in intensive care and compare them with samples from healthy volunteers. By analyzing gut microbes and blood markers, they hope to uncover biological pathways that could lead to better prediction or treatment of organ damage during sepsis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If links are found, it could point toward new ways to predict or prevent organ damage in sepsis by targeting the gut microbiome.
- What could go wrong
- This is an observational study, not a treatment trial. It can only show associations, not cause and effect, and results may not lead to immediate clinical changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population comprises two distinct groups recruited from multiple clinical centers. The primary clinical cohort consists of critically ill adult patients (aged ≥ 18 years) admitted to the Intensive Care Unit (ICU) who are diagnosed with sepsis according to the Sepsis-3 criteria and enrolled within 24 hours after sepsis diagnosis. This cohort will be monitored to observe longitudinal changes in the gut microbiome and the occurrence of sepsis-associated liver injury (SALI) and sepsis-associated acute kidney injury (S-AKI) from Day 0 through Day 7 after sepsis diagnosis. The secondary control cohort consists of healthy adult volunteers recruited from the community. These volunteers have no history of chronic underlying diseases or recent antibiotic/probiotic use, and they serve to establish baseline healthy profiles for the gut microbiome and circulating metabolites.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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First Affiliated hospital of zhejiang university school of medicine
RECRUITINGHangzhou, Zhejiang, 310000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Does COVID-19 hide in the gut? scientists probe stool for clues
- Can a simple ultrasound measurement reveal heart strain in sepsis?
- Clotting clues: simple blood test eyed to catch sepsis before it turns deadly
- Can two blood markers catch sepsis before it turns deadly?