A Multicenter Clinical Study on Protein Absorption Efficiency in Patients With Pancreatic Exocrine Insufficiency in the ICU

Overview

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

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: 1. 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. 2. 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.