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

25. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Jiancheng Zhang, MD, PhD
  • Telefonnummer: 13554105815
  • E-Mail: zhjcheng1@126.com

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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).
Experimental: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
All-Cause Mortality at 90 Days
Zeitfenster: 90 days post-enrollment
Proportion of participants who die from any cause within 90 days following enrollment.
90 days post-enrollment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
ICU Mortality
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 7 days post-enrollment
Total positive fluid balance (in milliliters) accumulated within 7 days after enrollment.
7 days post-enrollment
Incidence of ICU Delirium
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juli 2026

Primärer Abschluss (Geschätzt)

15. Juli 2028

Studienabschluss (Geschätzt)

15. Oktober 2028

Studienanmeldedaten

Zuerst eingereicht

19. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juni 2026

Zuerst gepostet (Tatsächlich)

26. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • zjc202601

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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