SepsisFOCUSNCT07670299
FMT for 90-Day Outcome of Clinical Use in ICU Sepsis
A study testing Gut microbiota suspension in people with Sepsis and Critical Illness, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sepsis, Critical Illness, Gastrointestinal Dysfunction
- What is being tested?
- Gut microbiota suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 15 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, any ethnicity, any gender.
- Diagnosis of sepsis according to the Sepsis-3 criteria (infection with an acute change in SOFA score ≥ 2 points).
- Signed written informed consent.
Who cannot join
- Patients whom the attending clinician considers to have a high risk of death within 5 days, or patients with treatment limitations in place.
- Active major gastrointestinal bleeding, perforation, or other severe impairment of the intestinal barrier.
- Patients unable to tolerate enteral nutrition meeting ≥50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stricture, severe gastrointestinal bleeding, or high-output intestinal fistula.
- Planned or recent abdominal surgery (within 14 days).
- Current diagnosis of fulminant colitis or toxic megacolon.
- Recent receipt of high-risk immunosuppressive or cytotoxic therapy, such as rituximab, doxorubicin, or moderate-to-high-dose corticosteroids (≥20 mg/day of prednisone or equivalent) for more than 4 consecutive weeks.
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- Pregnant or breastfeeding women.
- Participation in another clinical trial as a subject at the time of enrollment or within 3 months prior to enrollment.
- Subjects for whom the validity of informed consent is questionable, including those with psychiatric disorders, intellectual disability, poor motivation, or other conditions that may limit their ability to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Fecal Microbiota Transplantation for 90-Day Outcome of Clinical Use in ICU Sepsis: a Single-Center, Open-Label, Randomized Controlled Trial
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.
- Conditions
- Sepsis, Critical Illness, Gastrointestinal Dysfunction, Dysbiosis, Fecal Microbiota Transplantation
- Being tested
- Gut microbiota suspension
- Medical subject headings
- Sepsis, Critical Illness, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut microbiota suspensionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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). |
| FMT Intervention Group | Experimental | 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. Receives: Other: Gut microbiota suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality at 90 Days
Proportion of participants who die from any cause within 90 days following enrollment.
Measured: 90 days post-enrollment
Secondary outcomes (17)
ICU Mortality
Proportion of participants who die from any cause during their stay in the intensive care unit (ICU).
Measured: ICU stay, assessed up to 90 days
In-Hospital Mortality
Proportion of participants who die from any cause during the index hospitalization.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 7 days post-enrollment
Change in serum level of C-reactive protein (CRP)
Serial measurements of serum CRP levels.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the FMT administration period (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Jul 2028 (estimated)
- Study completion15 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiancheng Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670299
- Sponsor's protocol ID
- zjc202601
- Acronym
- FOCUS
- Status last verified
- Sep 2026
- First submitted
- 19 Jun 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for 90-Day Outcome of Clinical Use in ICU Sepsis: a Single-Center, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07670299
- Acronym / sponsor ID
- FOCUS / zjc202601
- Conditions
- Sepsis, Critical Illness, Gastrointestinal Dysfunction, Dysbiosis, Fecal Microbiota Transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 15 Oct 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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). |
| FMT Intervention Group | Experimental | Other: Gut microbiota suspensionParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years, any ethnicity, any gender.
- Diagnosis of sepsis according to the Sepsis-3 criteria (infection with an acute change in SOFA score ≥ 2 points).
- Signed written informed consent.
Key exclusion criteria (9 listed)
- Patients whom the attending clinician considers to have a high risk of death within 5 days, or patients with treatment limitations in place.
- Active major gastrointestinal bleeding, perforation, or other severe impairment of the intestinal barrier.
- Patients unable to tolerate enteral nutrition meeting ≥50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stricture, severe gastrointestinal bleeding, or high-output intestinal fistula.
- Planned or recent abdominal surgery (within 14 days).
- Current diagnosis of fulminant colitis or toxic megacolon.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gut microbiota suspensionFMT 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. | Other | FMT Intervention Group |
Primary outcome
All-Cause Mortality at 90 Days
Time frame: 90 days post-enrollment
Proportion of participants who die from any cause within 90 days following enrollment.
17 secondary outcomes
ICU Mortality
Time frame: ICU stay, assessed up to 90 days
In-Hospital Mortality
Time frame: Hospitalization period, assessed up to 90 days
28-Day All-Cause Mortality
Time frame: 28 days post-enrollment
Change in Gut Microbiota Composition
Time frame: Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT.
Change in Fecal Metabolome
Time frame: Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT
Change in serum Metabolome
Time frame: Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT
Serum Citrulline Concentration
Time frame: Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Change in Sequential Organ Failure Assessment (SOFA) Score
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
Time frame: Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Cumulative total dose of vasoactive agents
Time frame: 7 days post-enrollment
Change in serum level of C-reactive protein (CRP)
Time frame: Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Change in serum level of procalcitonin (PCT)
Time frame: Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Cumulative Fluid Balance
Time frame: 7 days post-enrollment
Incidence of ICU Delirium
Time frame: Up to 7 days post-enrollment (during ICU stay)
Incidence of Feeding Intolerance
Time frame: Up to 7 days post-enrollment (during ICU stay)
90-Day Hospital Readmission Rate
Time frame: 90 days post-discharge
Incidence of FMT-Related Adverse Events
Time frame: During the FMT administration period (up to 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Gut microbiota suspension in people with Sepsis and Critical Illness, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiancheng Zhang, MD, PhD (13554105815, zhjcheng1@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality at 90 Days (time frame: 90 days post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.