An interventional study of Gut microbiota suspension in Sepsis, Critical Illness and Gastrointestinal Dysfunction, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Not applicable, Interventional, and Treatment
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, representing one of the leading causes of death in intensive care units (ICUs) worldwide. Gut microbiota disruption is increasingly recognized as a key driver of persistent inflammation and multiple organ dysfunction in septic patients. Fecal microbiota transplantation (FMT) has emerged as a promising approach to restore gut microbial homeostasis. This study hypothesizes that FMT acts not through long-term engraftment of donor microbes, but via a "functional pulse" - a potent, transient biological intervention that delivers high-dose microbial metabolites (e.g., short-chain fatty acids), competitively inhibits pathogens, and rapidly modulates intestinal immune cell functions.
This is a single-center, open-label, randomized controlled trial conducted in the ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. A total of 60 adult patients diagnosed with sepsis according to Sepsis-3 criteria within 24 hours of ICU admission will be randomized in a 1:1 ratio to receive either ICU standard care alone (control group) or ICU standard care plus FMT administered via a nasojejunal tube for three consecutive days (intervention group). The primary endpoint is all-cause mortality at 90 days. Secondary endpoints include ICU mortality, in-hospital mortality, 28-day mortality, changes in gut microbiota composition and metabolites, serum citrulline levels as a marker of intestinal barrier function, Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, vasopressor requirements, C-reactive protein and procalcitonin levels, fluid balance, incidence of ICU delirium and feeding intolerance, and 90-day hospital readmission rate. Safety outcomes include gastrointestinal symptoms and transient fever.
Exclusion Criteria:
Participants in this arm will receive standard ICU care according to current clinical guidelines and standard practice, including vital sign monitoring, treatment of underlying diseases, nutritional support, and sedation/analgesia management. Participants will not receive fecal microbiota transplantation (FMT).
Participants in this arm will receive standard ICU care plus FMT administered via a nasojejunal tube. FMT will be given once daily for 3 consecutive days, with 50-100 mL of fecal microbiota suspension administered between 11:00 and 13:00 each day. No oral antibiotics are allowed during the FMT period.
Other: Gut microbiota suspension
FMT is a biologic intervention that involves the transfer of functional microbiota from the feces of healthy screened donors into the recipient's intestinal tract to restore gut microbial diversity and ecological stability. The FMT product is prepared from 100-150 g of adolescent donor feces, processed into 300 mL of fecal microbiota suspension, with each 50-100 mL. Patients in the intervention group receive FMT via nasojejunal tube on 3 consecutive days, with 50 mL of fecal microbiota suspension administered daily between 11:00 AM and 1:00 PM. Patients are fasting for at least 2 hours before FMT and remain fasting for 2 hours after each administration. The intervention is administered in addition to standard ICU care.
All-Cause Mortality at 90 Days
Proportion of participants who die from any cause within 90 days following enrollment.
Time frame: 90 days post-enrollment
ICU Mortality
Proportion of participants who die from any cause during their stay in the intensive care unit (ICU).
Time frame: ICU stay, assessed up to 90 days
In-Hospital Mortality
Proportion of participants who die from any cause during the index hospitalization.
Time frame: Hospitalization period, assessed up to 90 days
28-Day All-Cause Mortality
Proportion of participants who die from any cause within 28 days after enrollment.
Time frame: 28 days post-enrollment
Change in Gut Microbiota Composition
Changes in gut microbial community structure assessed by 16S rRNA gene sequencing of fecal samples or rectal swabs, including: (1) alpha diversity (within-sample richness and evenness), (2) beta diversity (between-sample dissimilarity), and (3) alterations in relative abundance of key bacterial taxa at phylum and genus levels.
Time frame: Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT.
Change in Fecal Metabolome
Changes in the fecal metabolic profile, including short-chain fatty acids and other microbial-derived metabolites, assessed using untargeted metabolomics.
Time frame: Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT
Change in serum Metabolome
Changes in the serum metabolic profile, including short-chain fatty acids and other microbial-derived metabolites, assessed using untargeted metabolomics.
Time frame: Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT
Serum Citrulline Concentration
Serial measurements of serum citrulline concentration, an indicator of intestinal epithelial cell mass and enterocyte function.
Time frame: Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Change in Sequential Organ Failure Assessment (SOFA) Score
Change in SOFA score, which ranges from 0 to 24 (higher scores indicate more severe organ dysfunction).
Time frame: Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Change in Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
Change in APACHE II score, which ranges from 0 to 71 (higher scores indicate more severe illness and higher mortality risk).
Time frame: Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Cumulative total dose of vasoactive agents
Cumulative total dose of vasoactive agents (expressed as norepinephrine equivalents) administered from enrollment through 7 days post-enrollment.
Time frame: 7 days post-enrollment
Change in serum level of C-reactive protein (CRP)
Serial measurements of serum CRP levels.
Time frame: Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Change in serum level of procalcitonin (PCT)
Serial measurements of serum PCT levels.
Time frame: Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Cumulative Fluid Balance
Total positive fluid balance (in milliliters) accumulated within 7 days after enrollment.
Time frame: 7 days post-enrollment
Incidence of ICU Delirium
Incidence of delirium during the ICU stay, assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
Time frame: Up to 7 days post-enrollment (during ICU stay)
Incidence of Feeding Intolerance
Incidence of feeding intolerance, defined as the inability to achieve an enteral nutrition target of 20 kcal/(kg·d) within 72 hours due to any clinical reason (e.g., vomiting, diarrhea, or enterocutaneous fistula), or cessation of enteral nutrition for any clinical reason, excluding temporary interruptions for clinical procedures or operational reasons.
Time frame: Up to 7 days post-enrollment (during ICU stay)
90-Day Hospital Readmission Rate
Proportion of participants readmitted to the hospital for any cause within 90 days after discharge from the index hospitalization.
Time frame: 90 days post-discharge
Incidence of FMT-Related Adverse Events
Incidence of adverse events potentially associated with FMT, including gastrointestinal symptoms (nausea, vomiting, abdominal pain, abdominal distension, and diarrhea) and transient fever.
Time frame: During the FMT administration period (up to 7 days)
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Plan to share: No
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology