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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai 10th People's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Short peptide

    Drug

    Short peptide EN preparations were administered for nutritional support

  • Protein

    Drug

    Nutritional support therapy was administered with protein-type EN preparations

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Short peptide groupExperimental treatment 1 intervention
Group B: Protein groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Branched-chain amino acid concentration

Time frame
Week 1
2

Citrulline concentration

Time frame
Week 1
3

Urine 3-methylhistidine concentration

Time frame
Week 1

Secondary outcomes

1

Fecal elastase-1

Time frame
Week 1
2

Serum pancreatic lipase levels

Time frame
Week 1
3

Serum pancreatic amylase levels

Time frame
Week 1
4

Plasma diamine oxidase levels

Time frame
Week 1

Other outcomes

Sponsors and contacts

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Shanghai 10th People's Hospital

Lead sponsor

Shanghai Tongji Hospital, Tongji University School of Medicine

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: