A Phase 4 interventional study of Short peptide and Protein in High-risk Patients With Pancreatic Exocrine Insufficiency and Enteral Nutrition Feeding, sponsored by Shanghai 10th People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Shanghai 10th People's Hospital · Phase 4, Interventional, and Treatment
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.
136 studies on the registry are indexed under Exocrine Pancreatic Insufficiency; 26 are open to participants now.
This study's planned enrollment of 250 is above the median of 40 across 94 interventional studies indexed under Exocrine Pancreatic Insufficiency.
Browse Exocrine Pancreatic Insufficiency studies →Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short peptide EN preparations were administered for nutritional support
Drug: Short peptide
Nutritional support therapy was administered with protein type EN preparations
Drug: Protein
Short peptide EN preparations were administered for nutritional support
Nutritional support therapy was administered with protein-type EN preparations
Branched-chain amino acid concentration
Time frame: Week 1
Citrulline concentration
Time frame: Week 1
Urine 3-methylhistidine concentration
Time frame: Week 1
Fecal elastase-1
Time frame: Week 1
Serum pancreatic lipase levels
Time frame: Week 1
Serum pancreatic amylase levels
Time frame: Week 1
Plasma diamine oxidase levels
Time frame: Week 1
Plasma D-lactate level
Time frame: Week 1
P-cresol content in feces
Time frame: Week 1
Indole content in feces
Time frame: Week 1
Ultrasound is used to detect the thickness of the rectus femoris and assess the degree of muscle attenuation
Time frame: Week 2
28-day all-cause mortality
Time frame: Week 4
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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