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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short peptide group | Experimental | Short peptide EN preparations were administered for nutritional support |
|
| Protein group | Active Comparator | Nutritional support therapy was administered with protein type EN preparations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short peptide | Drug | Short peptide EN preparations were administered for nutritional support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Branched-chain amino acid concentration | Week 1 | |
| Citrulline concentration | Week 1 | |
| Urine 3-methylhistidine concentration | Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal elastase-1 | Week 1 | |
| Serum pancreatic lipase levels | Week 1 | |
| Serum pancreatic amylase levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Wang | Contact | +8613641715292 | wangsheng@tongji.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tongji Hospital | Shanghai | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2026 |
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Subjects meeting the inclusion criteria were randomly assigned to either the short peptide group and the whole protein group according to a 1:1 randomization scheme. The specific grouping scheme is as follows: 1) Short peptide group: Short peptide EN preparations are given for nutritional support therapy, with a protein content of 5 g/100ml and 100% hydrolyzed whey protein, which can be absorbed by the intestines without sufficient pancreatic enzyme digestion; 2) Protein group: Provided protein-type EN preparations for nutritional support, with a protein content of 5 g/100 ml, all complete protein components, relying on pancreatic enzymes secreted for digestion and absorption.
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| Protein | Drug | Nutritional support therapy was administered with protein-type EN preparations |
|
| 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 |
| Jul 13, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2026 | Jul 13, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D010188 | Exocrine Pancreatic Insufficiency |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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