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

15 de septiembre de 2026 actualizado por: Jiancheng Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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).

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jiancheng Zhang
  • Número de teléfono: +86-13554105815
  • Correo electrónico: zhjcheng1@126.com

Ubicaciones de estudio

    • Hubei
      • Wuhan, Hubei, Porcelana, 460022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contacto:
          • Jiancheng Zhang
          • Número de teléfono: +86-13554105815
          • Correo electrónico: zhjcheng1@126.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control group
Patients received standard ICU care.
Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Enteral nutrition FI improvement rate
Periodo de tiempo: 24, 48, 72, 96, and 120 hours after study enrollment
24, 48, 72, 96, and 120 hours after study enrollment

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Gut microbiota composition as well as α and β diversity measured from rectal swabs by 16S rRNA gene sequencing
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 24-0 hours and 120 hours after study enrollment
24-0 hours and 120 hours after study enrollment
Serum level of citrulline
Periodo de tiempo: 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
Periodo de tiempo: 0, 24, 48, 72, 96, and 120 hours after study enrollment
0, 24, 48, 72, 96, and 120 hours after study enrollment
SOFA score
Periodo de tiempo: 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.)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.)
Periodo de tiempo: 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.)
Periodo de tiempo: 0, 24, 48, 72, 96, and 120 hours after study enrollment
0, 24, 48, 72, 96, and 120 hours after study enrollment
ICU mortality
Periodo de tiempo: Within 28 days after study enrollment
Within 28 days after study enrollment
In-hospital mortality
Periodo de tiempo: Within 60 days after study enrollment
Within 60 days after study enrollment
28-day all-cause mortality
Periodo de tiempo: Within 28 days after study enrollment
Within 28 days after study enrollment
90-day all-cause mortality
Periodo de tiempo: Within 90 days after study enrollment
Within 90 days after study enrollment
90-day readmission rate
Periodo de tiempo: Within 90 days after study enrollment
Within 90 days after study enrollment
90-day secondary infection rate
Periodo de tiempo: Within 90 days after study enrollment
Within 90 days after study enrollment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

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Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

30 de abril de 2027

Finalización del estudio (Estimado)

30 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

1 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de junio de 2026

Publicado por primera vez (Actual)

11 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • zjc202402

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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