A Multicenter Clinical Study on Protein Absorption Efficiency in Patients With Pancreatic Exocrine Insufficiency in the ICU
Comparison of Protein Absorption Efficiency Between Peptide and Whole Protein Enteral Nutrition Preparations in High-risk Groups With Pancreatic Exocrine Insufficiency in the ICU
The goal of this clinical trial is to systematically evaluate whether peptide-type enteral nutrition (EN) formulations improve protein uptake efficiency in high-risk groups at ICU PEI, using targeted amino acid metabolomics and gut microbiota co-metabolomics as core quantitative indicators.
Researchers will compare protein absorption efficiency of short-chain peptide and complete protein enteral nutrition formulas in high-risk populations for PEI in the ICU
Participants will:
Enteral nutrition was administered for ICU critically ill patients with high-risk factors for PEI
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study subjects that meet the inclusion criteria will be randomly assigned in a 1:1 ratio to the peptide group and the whole protein group according to the following allocation scheme:
- Peptide Group: Receives nutritional support therapy with a peptide-based enteral nutrition (EN) formulation. The selected formulation must contain 5 g of protein per 100 ml and be composed entirely of hydrolyzed whey protein, which can be absorbed by the intestine without the need for thorough digestion by pancreatic enzymes.
- Whole Protein Group: Receives nutritional support therapy with a whole protein-based EN formulation. The selected formulation also contains 5 g of protein per 100 ml and consists of intact protein components, which require digestion and breakdown by pancreatic enzymes before being absorbed.
Both groups of study subjects will strictly follow the 2025 ASPEN Guidelines for Nutritional Therapy in Critically Ill Patients and the relevant expert consensus on critical care nutrition in China. Apart from the difference in the type of EN formulation, all other treatment measures (including anti-infection therapy, organ function support, gastrointestinal motility regulation, sedation and analgesia) will be carried out in accordance with standard ICU clinical practices to ensure consistency in the baseline treatment conditions between the two groups.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sheng Wang
- Número de teléfono: +8613641715292
- Correo electrónico: wangsheng@tongji.edu.cn
Ubicaciones de estudio
-
-
-
Shanghai, Porcelana
- Shanghai Tongji Hospital
-
Contacto:
- Huihui Zhu
- Número de teléfono: +8615821646026
- Correo electrónico: huihui01727@163.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age≥ 18 years old, no gender restriction;
- Meet the criteria for high-risk groups for PEI;
- AGI≤ Class II, hemodynamically stable, meeting EN initiation criteria;
- Estimated duration of enteral nutrition support therapy: ≥7 days;
- The subject or their legally authorized family member must sign the informed consent form
Exclusion Criteria:
- Patients who have been clearly diagnosed with PEI or chronic persistent PEI;
- Patients who have contraindications to enteral nutrition therapy;
- Patients with severely impaired liver or kidney function;
- Patients who suffer from amino acid metabolism disorders, severe malnutrition, or cachexia;
- Patients who have received pancreatic enzyme replacement therapy or taken any medications that may affect protein absorption within 7 days prior to enrollment;
- Patients for whom the expected length of ICU stay is less than 7 days;
- Pregnant or lactating women, as well as patients with mental illnesses;
- Patients who are allergic to any component of the study medication.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Short peptide group
Short peptide EN preparations were administered for nutritional support
|
Short peptide EN preparations were administered for nutritional support
|
|
Comparador activo: Protein group
Nutritional support therapy was administered with protein type EN preparations
|
Nutritional support therapy was administered with protein-type EN preparations
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Branched-chain amino acid concentration
Periodo de tiempo: Week 1
|
Week 1
|
|
Citrulline concentration
Periodo de tiempo: Week 1
|
Week 1
|
|
Urine 3-methylhistidine concentration
Periodo de tiempo: Week 1
|
Week 1
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Fecal elastase-1
Periodo de tiempo: Week 1
|
Week 1
|
|
Serum pancreatic lipase levels
Periodo de tiempo: Week 1
|
Week 1
|
|
Serum pancreatic amylase levels
Periodo de tiempo: Week 1
|
Week 1
|
|
Plasma diamine oxidase levels
Periodo de tiempo: Week 1
|
Week 1
|
|
Plasma D-lactate level
Periodo de tiempo: Week 1
|
Week 1
|
|
P-cresol content in feces
Periodo de tiempo: Week 1
|
Week 1
|
|
Indole content in feces
Periodo de tiempo: Week 1
|
Week 1
|
|
Ultrasound is used to detect the thickness of the rectus femoris and assess the degree of muscle attenuation
Periodo de tiempo: Week 2
|
Week 2
|
|
28-day all-cause mortality
Periodo de tiempo: Week 4
|
Week 4
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-047
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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. .