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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: Sheng Wang
- Numero di telefono: +8613641715292
- Email: wangsheng@tongji.edu.cn
Luoghi di studio
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Shanghai, Cina
- Shanghai Tongji Hospital
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Contatto:
- Huihui Zhu
- Numero di telefono: +8615821646026
- Email: huihui01727@163.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Short peptide group
Short peptide EN preparations were administered for nutritional support
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Short peptide EN preparations were administered for nutritional support
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Comparatore attivo: Protein group
Nutritional support therapy was administered with protein type EN preparations
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Nutritional support therapy was administered with protein-type EN preparations
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Branched-chain amino acid concentration
Lasso di tempo: Week 1
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Week 1
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Citrulline concentration
Lasso di tempo: Week 1
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Week 1
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Urine 3-methylhistidine concentration
Lasso di tempo: Week 1
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Week 1
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Fecal elastase-1
Lasso di tempo: Week 1
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Week 1
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Serum pancreatic lipase levels
Lasso di tempo: Week 1
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Week 1
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Serum pancreatic amylase levels
Lasso di tempo: Week 1
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Week 1
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Plasma diamine oxidase levels
Lasso di tempo: Week 1
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Week 1
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Plasma D-lactate level
Lasso di tempo: Week 1
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Week 1
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P-cresol content in feces
Lasso di tempo: Week 1
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Week 1
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Indole content in feces
Lasso di tempo: Week 1
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Week 1
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Ultrasound is used to detect the thickness of the rectus femoris and assess the degree of muscle attenuation
Lasso di tempo: Week 2
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Week 2
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28-day all-cause mortality
Lasso di tempo: Week 4
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Week 4
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Collaboratori e investigatori
Sponsor
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Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-047
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