SepsisNCT07038057
Comparison of Short Peptide and Whole Protein Formula in the Early Enteral Nutrition of Patients With Sepsis
A study testing Short peptide enteral nutrition and Whole protein enteral nutrition in people with Sepsis and Nutrition, run by Shanghai Zhongshan Hospital.
Trial summary
To explore the effects of early enteral nutrition with short peptide formula on energy metabolism and clinical outcomes in patients with sepsis based on blood samples, clinical database, full-spectrum metabolomics test and imaging data, and to form a theoretical basis for optimizing the formula of early enteral… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Short peptide enteral nutrition and Whole protein enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2025to 1 Mar 2027
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent has been signed
- Aged from 18 to 80 years old
- Within 24 hours after admission to ICU
- Sepsis was diagnosed according to the 2016 International Sepsis 3.0 diagnostic criteria
- Without gastrointestinal perforation, bleeding, obstruction and other contraindications to enteral nutrition
- Expected ICU stay for more than 7 days
Who cannot join
- Receiving palliative care or expected to die within 72 hours
- Pregnant or breastfeeding
- Use of high dose vasopressor maintenance (norepinephrine dosage > 0.5 μg/kg/min)
- Requiring restricted protein intake or additional protein supplementation (e.g., patients with hepatic encephalopathy, severe renal insufficiency, severe burns, severe malnutrition, etc..)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Short Peptide and Whole Protein Formula in the Early Enteral Nutrition of Patients With Sepsis: a Single-Center, Prospective, Randomized Controlled Study
To explore the effects of early enteral nutrition with short peptide formula on energy metabolism and clinical outcomes in patients with sepsis based on blood samples, clinical database, full-spectrum metabolomics test and imaging data, and to form a theoretical basis for optimizing the formula of early enteral nutrition in patients with sepsis.
Read the detailed description
This study is a single-center prospective trial. Based on the annual patient volume, available human resources, and funding at our research center, the expert team determined a sample size of 80 cases, with 40 cases in the experimental group and 40 in the control group. Eligible participants will be randomized 1:1 via computer-generated randomization into two groups, receiving either a short-peptide-based enteral nutrition formula or a whole-protein-based enteral nutrition formula.
Short-peptide formula group:
Within 48 hours of ICU admission, short-peptide-based enteral nutrition (Peptisorb) will be initiated. For patients with impaired swallowing or unconsciousness, a nasogastric tube will be placed. Feeding will start with low-calorie or trophic feeding, reaching 70% of the target energy and 1.2-1.5 g/kg/day of protein within 7 days. Due to significant individual variability in energy expenditure among sepsis patients, indirect calorimetry (IC) will be used to measure energy needs. If IC is unavailable, a weight-based formula (20-25 kcal/kg/day) will be applied. If patients remain in the ICU after 7 days, feeding will be gradually increased to full energy and protein targets as tolerated, followed by a transition to whole-protein nutrition.
Whole-protein formula group:
Within 48 hours of ICU admission, whole-protein-based enteral nutrition (Nutrison) will be initiated, with the remaining protocol identical to the short-peptide group.
The study will assess changes in metabolomics after 7 days of early enteral nutrition with different protein formulations in sepsis patients, as well as differences in nutritional status, biochemical markers, and short- and long-term clinical outcomes.
- Being tested
- Short peptide enteral nutrition, Whole protein enteral nutrition
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short peptide enteral nutritionDietary supplement
Short peptide formula enteral nutrition was initiated within 48 hours after admission to the ICU. For patients with poor swallowing function or no consciousness, nasogastric tubes were placed. Starting from low-calorie or nourishing feeding, 70% of the target energy should be achieved within 7 days, and the protein should be 1.2-1.5 g/kg/d. Due to the large individual differences in energy expenditure among patients with sepsis, the indirect calorimetry (IC) method was used to determine energy expenditure. If the IC method is not feasible, the calculation formula based on body weight: 20-25 kcal/kg/d should be applied for calculation. If the patient is not transferred out of the ICU after 7 days, continue to gradually increase to the target energy and protein requirements under tolerable conditions, and gradually transition to whole protein nutrition after 7 days.
Whole protein enteral nutritionDietary supplement
The whole protein formula enteral nutrition was initiated within 48 hours of admission to the ICU, and the rest were same.
| Study group | Role | What they receive |
|---|---|---|
| Short peptide formula | Experimental | Within 48 hours of ICU admission, short-peptide-based enteral nutrition (Peptisorb) will be initiated. For patients with impaired swallowing or unconsciousness, a nasogastric tube will be placed. Feeding will start with low-calorie or trophic feeding, reaching 70% of the target energy and 1.2-1.5 g/kg/day of protein within 7 days. Due to significant individual variability in energy expenditure among sepsis patients, indirect calorimetry (IC) will be used to measure energy needs. If IC is unavailable, a weight-based formula (20-25 kcal/kg/day) will be applied. If patients remain in the ICU after 7 days, feeding will be gradually increased to full energy and protein targets as tolerated, followed by a transition to whole-protein nutrition. Receives: Dietary Supplement: Short peptide enteral nutrition |
| Whole protein formula | Active comparator | Within 48 hours of ICU admission, whole-protein-based enteral nutrition (Nutrison) will be initiated, with the remaining protocol identical to the short-peptide group. Receives: Dietary Supplement: Whole protein enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomics changes form
Key assessments include: ① Concentration changes of differential metabolites in core pathways (BCAA, SCFA, bile acid metabolism); ② Correlation between metabolite fluctuations and nutritional markers (albumin, prealbumin); ③ Predictive modeling linking metabolic signatures to clinical outcomes (infection rate, ICU LOS). The above data were all normalized and ultimately presented in the form of a heatmap.
Measured: On the 7th day after enrollment
Secondary outcomes (12)
Daily average protein intake
Daily average protein intake, including EN, PN, IVAA, and measurable oral protein supplements; oral diets with unquantifiable protein content excluded (Unit: g).
Measured: 7 days
Daily average energy intake
Daily average energy intake (Unit: g).
Measured: 7 days
Energy adequacy rate
Energy adequacy rate on the 3rd and 7th day after enrollment (Unit: %).
Measured: On the 3rd and 7th day after enrollment
Inflammatory markers
Including C-reactive protein (CRP) (Unit: mg/L), White blood cell count (WBC) (Unit: *10^9/L), and Neutrophil count (Neut#) (Unit: *10^9/L).
Measured: 7 days
Nutritional status
Albumin (Alb) (Unit: g/L) and Pre-albumin (PA) (Unit: mg/L).
Measured: 7 days
Liver function
Bilirubin (BIL) (Unit: μmol/L)
Measured: 7 days
Renal function
Blood urea nitrogen (BUN) (Unit: mmol/L) and Serum creatinine (Cr) (Unit: umol/L).
Measured: 7 days
Enteral nutritional tolerance rate
Manifestations of enteral nutrition intolerance:
Gastric retention (gastric residual volume > 500 mL within 4 hours) Severe nausea or vomiting; Abdominal distension; Diarrhea (≥ 3 bowel movements per day with loose stools, Bristol Stool Scale type 5-7); Hematochezia leading to hemodynamic instability.
Measured: 7 days
Skeletal muscle depletion condition
A single cross-sectional image at the L3 level was obtained via CT scan. Skeletal muscle was identified and quantified within the image using Hounsfield Unit (HU) thresholds of -29 to +150. The total muscle area at this level was calculated using ImageJ image analysis software. After normalization by the square of height (m²), the third lumbar skeletal muscle index (L3-SMI) was derived.
Measured: 7 days
Days of ventilator use
Measured: 28 days
28-day all-cause mortality rate
Measured: 28 days
All-cause mortality at 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start25 Jun 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Zhong, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038057
- Sponsor's protocol ID
- B2025-213R
- Status last verified
- Jun 2025
- First submitted
- 12 May 2025
- Last updated
- 26 Jun 2025
- 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 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short Peptide and Whole Protein Formula in the Early Enteral Nutrition of Patients With Sepsis: a Single-Center, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07038057
- Acronym / sponsor ID
- B2025-213R
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 26 Jun 2025 (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.
To explore the effects of early enteral nutrition with short peptide formula on energy metabolism and clinical outcomes in patients with sepsis based on blood samples, clinical database, full-spectrum metabolomics test and imaging data, and to form a theoretical basis for optimizing the formula of early enteral nutrition in patients with sepsis.
Detailed description
This study is a single-center prospective trial. Based on the annual patient volume, available human resources, and funding at our research center, the expert team determined a sample size of 80 cases, with 40 cases in the experimental group and 40 in the control group. Eligible participants will be randomized 1:1 via computer-generated randomization into two groups, receiving either a short-peptide-based enteral nutrition formula or a whole-protein-based enteral nutrition formula.
Short-peptide formula group:
Within 48 hours of ICU admission, short-peptide-based enteral nutrition (Peptisorb) will be initiated. For patients with impaired swallowing or unconsciousness, a nasogastric tube will be placed. Feeding will start with low-calorie or trophic feeding, reaching 70% of the target energy and 1.2-1.5 g/kg/day of protein within 7 days. Due to significant individual variability in energy expenditure among sepsis patients, indirect calorimetry (IC) will be used to measure energy needs. If IC is unavailable, a weight-based formula (20-25 kcal/kg/day) will be applied. If patients remain in the ICU after 7 days, feeding will be gradually increased to full energy and protein targets as tolerated, followed by a transition to whole-protein nutrition.
Whole-protein formula group:
Within 48 hours of ICU admission, whole-protein-based enteral nutrition (Nutrison) will be initiated, with the remaining protocol identical to the short-peptide group.
The study will assess changes in metabolomics after 7 days of early enteral nutrition with different protein formulations in sepsis patients, as well as differences in nutritional status, biochemical markers, and short- and long-term clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short peptide formula | Experimental | Dietary Supplement: Short peptide enteral nutritionWithin 48 hours of ICU admission, short-peptide-based enteral nutrition (Peptisorb) will be initiated. For patients with impaired swallowing or unconsciousness, a nasogastric tube will be placed. Feeding will start with low-calorie or trophic feeding, reaching 70% of the target energy and 1.2-1.5 g/kg/day of protein within 7 days. Due to significant individual variability in energy expenditure among sepsis patients, indirect calorimetry (IC) will be used to measure energy needs. If IC is unavailable, a weight-based formula (20-25 kcal/kg/day) will be applied. If patients remain in the ICU after 7 days, feeding will be gradually increased to full energy and protein targets as tolerated, followed by a transition to whole-protein nutrition. |
| Whole protein formula | Active comparator | Dietary Supplement: Whole protein enteral nutritionWithin 48 hours of ICU admission, whole-protein-based enteral nutrition (Nutrison) will be initiated, with the remaining protocol identical to the short-peptide group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent has been signed
- Aged from 18 to 80 years old
- Within 24 hours after admission to ICU
- Sepsis was diagnosed according to the 2016 International Sepsis 3.0 diagnostic criteria
- Without gastrointestinal perforation, bleeding, obstruction and other contraindications to enteral nutrition
Key exclusion criteria (4 listed)
- Receiving palliative care or expected to die within 72 hours
- Pregnant or breastfeeding
- Use of high dose vasopressor maintenance (norepinephrine dosage > 0.5 μg/kg/min)
- Requiring restricted protein intake or additional protein supplementation (e.g., patients with hepatic encephalopathy, severe renal insufficiency, severe burns, severe malnutrition, etc..)
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 peptide enteral nutritionShort peptide formula enteral nutrition was initiated within 48 hours after admission to the ICU. For patients with poor swallowing function or no consciousness, nasogastric tubes were placed. Starting from low-calorie or nourishing feeding, 70% of the target energy should be achieved within 7 days, and the protein should be 1.2-1.5 g/kg/d. Due to the large individual differences in energy expenditure among patients with sepsis, the indirect calorimetry (IC) method was used to determine energy expenditure. If the IC method is not feasible, the calculation formula based on body weight: 20-25 kcal/kg/d should be applied for calculation. If the patient is not transferred out of the ICU after 7 days, continue to gradually increase to the target energy and protein requirements under tolerable conditions, and gradually transition to whole protein nutrition after 7 days. | Dietary supplement | Short peptide formula |
| Whole protein enteral nutritionThe whole protein formula enteral nutrition was initiated within 48 hours of admission to the ICU, and the rest were same. | Dietary supplement | Whole protein formula |
Primary outcome
Metabolomics changes form
Time frame: On the 7th day after enrollment
Key assessments include: ① Concentration changes of differential metabolites in core pathways (BCAA, SCFA, bile acid metabolism); ② Correlation between metabolite fluctuations and nutritional markers (albumin, prealbumin); ③ Predictive modeling linking metabolic signatures to clinical outcomes (infection rate, ICU LOS). The above data were all normalized and ultimately presented in the form of a heatmap.
12 secondary outcomes
Daily average protein intake
Time frame: 7 days
Daily average energy intake
Time frame: 7 days
Energy adequacy rate
Time frame: On the 3rd and 7th day after enrollment
Inflammatory markers
Time frame: 7 days
Nutritional status
Time frame: 7 days
Liver function
Time frame: 7 days
Renal function
Time frame: 7 days
Enteral nutritional tolerance rate
Time frame: 7 days
Skeletal muscle depletion condition
Time frame: 7 days
Days of ventilator use
Time frame: 28 days
28-day all-cause mortality rate
Time frame: 28 days
All-cause mortality at 90 days
Time frame: 90 days
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 26 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Short peptide enteral nutrition and Whole protein enteral nutrition in people with Sepsis and Nutrition, run by Shanghai Zhongshan Hospital.
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 6 inclusion and 4 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 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Yanni Zhang, MD, PhD (+86 13381819621, yanni99@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomics changes form (time frame: On the 7th day after enrollment). 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 26 Jun 2025.