A Multicenter Clinical Study on Protein Absorption Efficiency in Patients With Pancreatic Exocrin… (NCT07709611) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Multicenter Clinical Study on Protein Absorption Efficiency in Patients With Pancreatic Exocrine Insufficiency in the ICU
China250 participantsStarted 2026-07-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.