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

Study Overview

• Status: Not yet recruiting
• Conditions: Enteral Nutrition Feeding; High-risk Patients With Pancreatic Exocrine Insufficiency
• Intervention / Treatment: Drug: Short peptide; Drug: Protein

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sheng Wang; Phone Number: +8613641715292; Email: wangsheng@tongji.edu.cn

Study Locations

• China
  • Shanghai, China
    • Shanghai Tongji Hospital
    • Contact: Huihui Zhu; Phone Number: +8615821646026; Email: huihui01727@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short peptide group; Short peptide EN preparations were administered for nutritional support	Drug: Short peptide; Short peptide EN preparations were administered for nutritional support
Active Comparator: Protein group; Nutritional support therapy was administered with protein type EN preparations	Drug: Protein; Nutritional support therapy was administered with protein-type EN preparations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Branched-chain amino acid concentration	Week 1
Citrulline concentration	Week 1
Urine 3-methylhistidine concentration	Week 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Fecal elastase-1	Week 1
Serum pancreatic lipase levels	Week 1
Serum pancreatic amylase levels	Week 1
Plasma diamine oxidase levels	Week 1
Plasma D-lactate level	Week 1
P-cresol content in feces	Week 1
Indole content in feces	Week 1
Ultrasound is used to detect the thickness of the rectus femoris and assess the degree of muscle attenuation	Week 2
28-day all-cause mortality	Week 4

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Enteral nutrition; Pancreatic exocrine Insufficiency; Peptide-based; Absorption efficiency
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Exocrine Pancreatic Insufficiency; Amino Acids, Peptides, and Proteins; Proteins
• Other Study ID Numbers: 2026-047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No