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FMT for Feeding Intolerance Due to Gastrointestinal Dysfunction in Critically Ill Patients (FMT-FIT)

Fecal Microbiota Transplantation for Feeding Intolerance Due to Gastrointestinal Dysfunction in Critically Ill Patients: A Single-Center, Single-Blind, Randomized Controlled Trial

Critically ill patients admitted to the intensive care unit (ICU) frequently present with gastrointestinal dysfunction and are at elevated risk of malnutrition. Gastrointestinal dysfunction is correlated with adverse clinical outcomes, including prolonged mechanical ventilation duration, extended ICU length of stay, and increased 90-day mortality.

In critically ill ICU patients, severe gut microbiota dysbiosis and intestinal barrier impairment may occur due to the burden of primary critical illnesses, as well as the administration of proton pump inhibitors and antibiotics. This cascade contributes to a high prevalence of gastrointestinal dysfunction, alongside profound gut-derived systemic inflammatory responses and organ damage. Given the pivotal role of gut microbiota in maintaining intestinal homeostasis, fecal microbiota transplantation (FMT) holds promise as a novel therapeutic strategy for enteral feeding intolerance secondary to gastrointestinal dysfunction in critically ill ICU patients.

This study intends to deliver FMT via a nasojejunal tube to critically ill patients with gastrointestinal dysfunction admitted to the ICU. Its objectives are to evaluate the intervention's effects on gastrointestinal function recovery and the alleviation of enteral feeding intolerance, while also assessing its impacts on intestinal barrier function, gut microbiota composition and metabolic profiles, serum metabolite signatures, immune-inflammatory responses (including lymphocyte subsets, cytokines, C-reactive protein, and procalcitonin), ICU delirium, ICU sleep quality, and clinical outcomes (encompassing ICU mortality, in-hospital mortality, 28-day all-cause mortality, 90-day all-cause mortality, 90-day readmission rate, and 90-day incidence of secondary infections).

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Hubei
      • Wuhan, Hubei, Kina, 460022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Aged 18 to 70 years inclusive, regardless of ethnicity or gender;
  2. Female participants are either non-fertile (i.e., physiologically incapable of pregnancy, including women with ≥2 years of menopause) or have no pregnancy plans;
  3. Have been admitted to the ICU for ≥24 hours;
  4. Expected ICU stay ≥7 days after study enrollment;
  5. Screened positive for ≥1 manifestation of gastrointestinal dysfunction (intra-abdominal hypertension [IAH], massive gastric retention, diarrhea, lower gastrointestinal paralysis, bowel dilatation); enteral nutrition is then implemented under the guidance of the enteral feeding intolerance (FI) score, and participants with persistent FI after a 3-day trial are formally enrolled;
  6. Participants can actively cooperate or passively complete relevant examinations and follow-up procedures;
  7. Have signed a written informed consent form.

Exclusion Criteria:

  1. Severe systemic infection in the early resuscitation phase, with hemodynamic instability, insufficient tissue perfusion, or severe fluid-electrolyte and acid-base imbalances;
  2. Patients assessed by clinicians as having a high risk of death within 5 days, or those with restricted treatment decisions;
  3. Active gastrointestinal bleeding, perforation, or other conditions with severe intestinal barrier impairment;
  4. Patients unable to tolerate enteral nutrition meeting 50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stenosis, massive gastrointestinal bleeding, or high-output enterocutaneous fistula;
  5. Planned or recent abdominal surgery (within 14 days prior to enrollment);
  6. Current diagnosis of fulminant colitis or toxic megacolon;
  7. Neutropenia (neutrophil count < 1500 cells/µL);
  8. Patients with congenital or acquired immunodeficiency disorders;
  9. Recent receipt of high-risk immunosuppressive or cytotoxic agents, e.g., rituximab, doxorubicin, or medium-to-high-dose corticosteroids (≥ 20 mg/day prednisone equivalent) for a duration of > 4 weeks;
  10. Pregnant or lactating women;
  11. Participation in another clinical trial as a subject at the time of enrollment or within 3 months prior to enrollment;
  12. Doubtful validity of informed consent: subjects with mental illness, intellectual disability, poor motivation, or other factors that restrict the validity of informed consent for participation in this study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control group
Patients received standard ICU care.
Eksperimentel: FMT intervention group
Patients received FMT via a nasojejunal tube in addition to standard ICU care. Specifically, 50-100 mL of intestinal microbiota suspension was administered daily via the nasojejunal tube between 11:00 and 13:00 for three consecutive days.
Patients received FMT via a nasojejunal tube in addition to standard ICU care. Specifically, 50-100 mL of intestinal microbiota suspension was administered daily via the nasojejunal tube between 11:00 and 13:00 for three consecutive days.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Enteral nutrition FI improvement rate
Tidsramme: 24, 48, 72, 96, and 120 hours after study enrollment
24, 48, 72, 96, and 120 hours after study enrollment

Sekundære resultatmål

Resultatmål
Tidsramme
Gut microbiota composition as well as α and β diversity measured from rectal swabs by 16S rRNA gene sequencing
Tidsramme: 24-0 hours and 120 hours after study enrollment
24-0 hours and 120 hours after study enrollment
Fecal metabolite profile (by untargeted LC-MS) from rectal swabs
Tidsramme: 24-0 hours and 120 hours after study enrollment
24-0 hours and 120 hours after study enrollment
Serum metabolite profile (by untargeted LC-MS)
Tidsramme: 24-0 hours and 120 hours after study enrollment
24-0 hours and 120 hours after study enrollment
Serum level of citrulline
Tidsramme: 0, 24, 48, 72, 96, and 120 hours after study enrollment
0, 24, 48, 72, 96, and 120 hours after study enrollment
APACHE II score
Tidsramme: 0, 24, 48, 72, 96, and 120 hours after study enrollment
0, 24, 48, 72, 96, and 120 hours after study enrollment
SOFA score
Tidsramme: 0, 24, 48, 72, 96, and 120 hours after study enrollment
0, 24, 48, 72, 96, and 120 hours after study enrollment
Cumulative intravenous dose of vasopressor agents (including norepinephrine, epinephrine, dobutamine, etc.)
Tidsramme: 0, 24, 48, 72, 96, and 120 hours after study enrollment
0, 24, 48, 72, 96, and 120 hours after study enrollment
Serum level of C-reactive protein
Tidsramme: 0, 24, 48, 72, 96, and 120 hours after study enrollment
0, 24, 48, 72, 96, and 120 hours after study enrollment
Serum level of procalcitonin
Tidsramme: 0, 24, 48, 72, 96, and 120 hours after study enrollment
0, 24, 48, 72, 96, and 120 hours after study enrollment
Peripheral blood level of cytokines (including IL-6, IL-17, TNF-α, IL-10, IL-1β, etc.)
Tidsramme: 0 and 120 hours after study enrollment
0 and 120 hours after study enrollment
Peripheral blood lymphocyte subsets (including CD4+ T, CD8+ T, B lymphocytes, NK cells, etc.)
Tidsramme: 0, 24, 48, 72, 96, and 120 hours after study enrollment
0, 24, 48, 72, 96, and 120 hours after study enrollment
ICU mortality
Tidsramme: Within 28 days after study enrollment
Within 28 days after study enrollment
In-hospital mortality
Tidsramme: Within 60 days after study enrollment
Within 60 days after study enrollment
28-day all-cause mortality
Tidsramme: Within 28 days after study enrollment
Within 28 days after study enrollment
90-day all-cause mortality
Tidsramme: Within 90 days after study enrollment
Within 90 days after study enrollment
90-day readmission rate
Tidsramme: Within 90 days after study enrollment
Within 90 days after study enrollment
90-day secondary infection rate
Tidsramme: Within 90 days after study enrollment
Within 90 days after study enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

30. april 2027

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • zjc202402

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Gastrointestinal dysfunktion

Kliniske forsøg med Fecal microbiota transplantation (FMT)

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