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

NCT07709611 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2026-047
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

High-risk Patients With Pancreatic Exocrine Insufficiency; Enteral Nutrition Feeding

Keywords

Pancreatic exocrine Insufficiency; Enteral nutrition; Peptide-based; Absorption efficiency

Outcome Measures

Primary Outcomes (3)

• Branched-chain amino acid concentration

  Week 1

• Citrulline concentration

  Week 1

• Urine 3-methylhistidine concentration

  Week 1

Secondary Outcomes (9)

• 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

Study Arms (2)

Short peptide group

EXPERIMENTAL

Short peptide EN preparations were administered for nutritional support

Drug: Short peptide

Protein group

ACTIVE COMPARATOR

Nutritional support therapy was administered with protein type EN preparations

Drug: Protein

Interventions

Short peptide DRUG

Short peptide EN preparations were administered for nutritional support

Short peptide group

Protein DRUG

Nutritional support therapy was administered with protein-type EN preparations

Protein group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tongji Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Interventions

Proteins

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Central Study Contacts

Sheng Wang

CONTACT

+8613641715292; wangsheng@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)