High-risk Patients With Pancreatic Exocrine InsufficiencyPhase 4NCT07709611
A Multicenter Clinical Study on Protein Absorption Efficiency in Patients With Pancreatic Exocrine Insufficiency in the ICU
A Phase 4 study testing Short peptide and Protein in people with High-risk Patients With Pancreatic Exocrine Insufficiency and Enteral Nutrition Feeding, run by Shanghai 10th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-risk Patients With Pancreatic Exocrine Insufficiency, Enteral Nutrition Feeding
- What is being tested?
- Short peptide and Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Tongji Hospital
Shanghai
Huihui Zhu, +8615821646026, huihui01727@163.com
About this study
Official title: Comparison of Protein Absorption Efficiency Between Peptide and Whole Protein Enteral Nutrition Preparations in High-risk Groups With Pancreatic Exocrine Insufficiency in the ICU
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
Read the detailed description
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:
- Peptide Group: Receives nutritional support therapy with a peptide-based enteral nutrition (EN) formulation. The selected formulation must contain 5 g of protein per 100 ml and be composed entirely of hydrolyzed whey protein, which can be absorbed by the intestine without the need for thorough digestion by pancreatic enzymes.
- Whole Protein Group: Receives nutritional support therapy with a whole protein-based EN formulation. The selected formulation also contains 5 g of protein per 100 ml and consists of intact protein components, which require digestion and breakdown by pancreatic enzymes before being absorbed.
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.
- Being tested
- Short peptide, Protein
- Keywords
- Pancreatic exocrine Insufficiency, Enteral nutrition, Peptide-based, Absorption efficiency
- Medical subject headings
- Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short peptideDrug
Short peptide EN preparations were administered for nutritional support
ProteinDrug
Nutritional support therapy was administered with protein-type EN preparations
| Study group | Role | What they receive |
|---|---|---|
| Short peptide group | Experimental | Short peptide EN preparations were administered for nutritional support Receives: Drug: Short peptide |
| Protein group | Active comparator | Nutritional support therapy was administered with protein type EN preparations Receives: Drug: Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Branched-chain amino acid concentration
Measured: Week 1
Citrulline concentration
Measured: Week 1
Urine 3-methylhistidine concentration
Measured: Week 1
Secondary outcomes (9)
Fecal elastase-1
Measured: Week 1
Serum pancreatic lipase levels
Measured: Week 1
Serum pancreatic amylase levels
Measured: Week 1
Plasma diamine oxidase levels
Measured: Week 1
Plasma D-lactate level
Measured: Week 1
P-cresol content in feces
Measured: Week 1
Indole content in feces
Measured: Week 1
Ultrasound is used to detect the thickness of the rectus femoris and assess the degree of muscle attenuation
Measured: Week 2
28-day all-cause mortality
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Patients With Pancreatic Exocrine InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Wang MD PhD, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709611
- Sponsor's protocol ID
- 2026-047
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Protein Absorption Efficiency Between Peptide and Whole Protein Enteral Nutrition Preparations in High-risk Groups With Pancreatic Exocrine Insufficiency in the ICU
- ClinicalTrials.gov ID
- NCT07709611
- Acronym / sponsor ID
- 2026-047
- Keywords
- Pancreatic exocrine Insufficiency, Enteral nutrition, Peptide-based, Absorption efficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- Peptide Group: Receives nutritional support therapy with a peptide-based enteral nutrition (EN) formulation. The selected formulation must contain 5 g of protein per 100 ml and be composed entirely of hydrolyzed whey protein, which can be absorbed by the intestine without the need for thorough digestion by pancreatic enzymes.
- Whole Protein Group: Receives nutritional support therapy with a whole protein-based EN formulation. The selected formulation also contains 5 g of protein per 100 ml and consists of intact protein components, which require digestion and breakdown by pancreatic enzymes before being absorbed.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Short peptide group | Experimental | Drug: Short peptideShort peptide EN preparations were administered for nutritional support |
| Protein group | Active comparator | Drug: ProteinNutritional support therapy was administered with protein type EN preparations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short peptideShort peptide EN preparations were administered for nutritional support | Drug | Short peptide group |
| ProteinNutritional support therapy was administered with protein-type EN preparations | Drug | Protein group |
Primary outcome
Branched-chain amino acid concentration
Time frame: Week 1
Citrulline concentration
Time frame: Week 1
Urine 3-methylhistidine concentration
Time frame: Week 1
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Short peptide and Protein in people with High-risk Patients With Pancreatic Exocrine Insufficiency and Enteral Nutrition Feeding, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng Wang (+8613641715292, wangsheng@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Branched-chain amino acid concentration (time frame: Week 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.