Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

FMT for 90-Day Outcome of Clinical Use in ICU Sepsis (FOCUS)

25 giugno 2026 aggiornato da: Jiancheng Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Jiancheng Zhang, MD, PhD
  • Numero di telefono: 13554105815
  • Email: zhjcheng1@126.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control Group
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).
Sperimentale: FMT Intervention Group
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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
All-Cause Mortality at 90 Days
Lasso di tempo: 90 days post-enrollment
Proportion of participants who die from any cause within 90 days following enrollment.
90 days post-enrollment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
ICU Mortality
Lasso di tempo: ICU stay, assessed up to 90 days
Proportion of participants who die from any cause during their stay in the intensive care unit (ICU).
ICU stay, assessed up to 90 days
In-Hospital Mortality
Lasso di tempo: Hospitalization period, assessed up to 90 days
Proportion of participants who die from any cause during the index hospitalization.
Hospitalization period, assessed up to 90 days
28-Day All-Cause Mortality
Lasso di tempo: 28 days post-enrollment
Proportion of participants who die from any cause within 28 days after enrollment.
28 days post-enrollment
Change in Gut Microbiota Composition
Lasso di tempo: Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT.
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.
Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT.
Change in Fecal Metabolome
Lasso di tempo: Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT
Changes in the fecal metabolic profile, including short-chain fatty acids and other microbial-derived metabolites, assessed using untargeted metabolomics.
Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT
Change in serum Metabolome
Lasso di tempo: Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT
Changes in the serum metabolic profile, including short-chain fatty acids and other microbial-derived metabolites, assessed using untargeted metabolomics.
Baseline (0 hours), 72 hours after the last FMT, and 28 days after the last FMT
Serum Citrulline Concentration
Lasso di tempo: Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Serial measurements of serum citrulline concentration, an indicator of intestinal epithelial cell mass and enterocyte function.
Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Change in Sequential Organ Failure Assessment (SOFA) Score
Lasso di tempo: Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Change in SOFA score, which ranges from 0 to 24 (higher scores indicate more severe organ dysfunction).
Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Change in Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
Lasso di tempo: Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Change in APACHE II score, which ranges from 0 to 71 (higher scores indicate more severe illness and higher mortality risk).
Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Cumulative total dose of vasoactive agents
Lasso di tempo: 7 days post-enrollment
Cumulative total dose of vasoactive agents (expressed as norepinephrine equivalents) administered from enrollment through 7 days post-enrollment.
7 days post-enrollment
Change in serum level of C-reactive protein (CRP)
Lasso di tempo: Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Serial measurements of serum CRP levels.
Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Change in serum level of procalcitonin (PCT)
Lasso di tempo: Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Serial measurements of serum PCT levels.
Baseline, 24, 48, 72, 96, 120, 144, and 168 hours post-enrollment
Cumulative Fluid Balance
Lasso di tempo: 7 days post-enrollment
Total positive fluid balance (in milliliters) accumulated within 7 days after enrollment.
7 days post-enrollment
Incidence of ICU Delirium
Lasso di tempo: Up to 7 days post-enrollment (during ICU stay)
Incidence of delirium during the ICU stay, assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
Up to 7 days post-enrollment (during ICU stay)
Incidence of Feeding Intolerance
Lasso di tempo: Up to 7 days post-enrollment (during ICU stay)
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.
Up to 7 days post-enrollment (during ICU stay)
90-Day Hospital Readmission Rate
Lasso di tempo: 90 days post-discharge
Proportion of participants readmitted to the hospital for any cause within 90 days after discharge from the index hospitalization.
90 days post-discharge
Incidence of FMT-Related Adverse Events
Lasso di tempo: During the FMT administration period (up to 7 days)
Incidence of adverse events potentially associated with FMT, including gastrointestinal symptoms (nausea, vomiting, abdominal pain, abdominal distension, and diarrhea) and transient fever.
During the FMT administration period (up to 7 days)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 luglio 2026

Completamento primario (Stimato)

15 luglio 2028

Completamento dello studio (Stimato)

15 ottobre 2028

Date di iscrizione allo studio

Primo inviato

19 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 giugno 2026

Primo Inserito (Effettivo)

26 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • zjc202601

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Gut microbiota suspension

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Trinidad & Tobago

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi