SepsisNCT07755033
Personalized Nutritional Formula for ICU Patients: A Study on Prognosis and Multidimensional Health Markers
A study testing Individualized Enteral Nutrition Formula and Standard Enteral Nutrition Formula in people with Sepsis and Nutrition, run by Chinese Medical Association.
Trial summary
This study aims to evaluate the effects of an individualized enteral nutrition formula on clinical outcomes in critically ill adult patients in the intensive care unit (ICU). Participants will be randomly assigned to one of two groups: the individualized nutrition group or the standard nutrition group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Nutrition, Gut -Microbiota
- What is being tested?
- Individualized Enteral Nutrition Formula and Standard Enteral Nutrition Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2026to 31 Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill patients admitted to the intensive care unit (ICU) who meet the indications for enteral nutrition support.
- Age ≥ 18 years. APACHE II score > 8 at ICU admission. Expected ICU length of stay > 7 days.
Who cannot join
- Age < 18 years. Pregnancy or lactation. Known allergy to any component of the enteral nutrition formula. Gastrointestinal bleeding, incomplete intestinal obstruction, or other conditions precluding full enteral nutrition.
- Known severe thyroid dysfunction (e.g., thyrotoxic crisis, myxedema coma, or uncontrolled hyperthyroidism/hypothyroidism).
- Chronic end-stage organ failure, including: New York Heart Association (NYHA) Class IV heart failure, Child-Pugh Class C cirrhosis, or Stage 5 chronic kidney disease (CKD).
- Primary intestinal diseases (e.g., Crohn's disease, ulcerative colitis, or intestinal malignancies), short bowel syndrome, or history of extensive small bowel resection (residual small intestine < 100 cm).
- Metabolic disorders that significantly affect nutritional metabolism (e.g., Sheehan's syndrome, or other conditions with major metabolic consequences) as determined by the investigator.
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: The Effect of an Individualized Nutrition Formula on Clinical Prognosis, Intestinal and Pulmonary Microbiota, Serum Metabolomics, and Macronutrient Balance in Critically Ill Patients: A Prospective Interventional Study
This study aims to evaluate the effects of an individualized enteral nutrition formula on clinical outcomes in critically ill adult patients in the intensive care unit (ICU). Participants will be randomly assigned to one of two groups: the individualized nutrition group or the standard nutrition group. In the individualized group, the total daily amount of enteral nutrition will be calculated and adjusted daily based on the patient's resting energy expenditure (measured by indirect calorimetry) and serum protein levels. In the standard group, a fixed-dose formula will be administered according to routine clinical protocols recommended by current guidelines. The intervention will be initiated within 48 hours of ICU admission and continued for up to 14 days or until ICU discharge. The study will assess clinical prognosis, as well as changes in gut and pulmonary microbiota, serum metabolomics, and macronutrient balance. The findings may provide evidence for personalized nutrition strategies in critically ill patients.
- Conditions
- Sepsis, Nutrition, Gut -Microbiota
- Being tested
- Individualized Enteral Nutrition Formula, Standard Enteral Nutrition Formula
- Keywords
- Critical Illness
- Medical subject headings
- Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Enteral Nutrition FormulaDietary supplement
Individualized Enteral Nutrition Formula Based on Daily Metabolic Measurements
Standard Enteral Nutrition FormulaDietary supplement
Standardized enteral nutrition formula will be administered according to the routine clinical protocol recommended by current guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Nutrition Group | Experimental | The total daily dose of enteral nutrition will be adjusted dynamically according to the patient's daily metabolic measurements. Receives: Dietary Supplement: Individualized Enteral Nutrition Formula |
| Standard Nutrition Group | Active comparator | A standardized enteral nutrition formula will be provided following the routine clinical protocol as recommended by current guidelines. Receives: Dietary Supplement: Standard Enteral Nutrition Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of ICU Stay
Total number of days from ICU admission to ICU discharge.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start28 Jul 2026 (estimated)
- Primary completion27 Jul 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Juanhong Shen, Chinese Medical Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755033
- Sponsor's protocol ID
- 2025-1120-02
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xi F, You Y, Ding W, Gao T, Cao Y, Tan S, Yu W. Association of longitudinal changes in skeletal muscle mass with prognosis and nutritional intake in acutely hospitalized patients with abdominal trauma: a retrospective observational study. Front Nutr. 2023 May 31;10:1085124. doi: 10.3389/fnut.2023.1085124. eCollection 2023.
PubMed 37324740
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Individualized Nutrition Formula on Clinical Prognosis, Intestinal and Pulmonary Microbiota, Serum Metabolomics, and Macronutrient Balance in Critically Ill Patients: A Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT07755033
- Acronym / sponsor ID
- 2025-1120-02
- Conditions
- Sepsis, Nutrition, Gut -Microbiota
- Keywords
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- 28 Jul 2026 (estimated)
- Primary completion
- 27 Jul 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Aug 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.
This study aims to evaluate the effects of an individualized enteral nutrition formula on clinical outcomes in critically ill adult patients in the intensive care unit (ICU). Participants will be randomly assigned to one of two groups: the individualized nutrition group or the standard nutrition group. In the individualized group, the total daily amount of enteral nutrition will be calculated and adjusted daily based on the patient's resting energy expenditure (measured by indirect calorimetry) and serum protein levels. In the standard group, a fixed-dose formula will be administered according to routine clinical protocols recommended by current guidelines. The intervention will be initiated within 48 hours of ICU admission and continued for up to 14 days or until ICU discharge. The study will assess clinical prognosis, as well as changes in gut and pulmonary microbiota, serum metabolomics, and macronutrient balance. The findings may provide evidence for personalized nutrition strategies in critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Nutrition Group | Experimental | Dietary Supplement: Individualized Enteral Nutrition FormulaThe total daily dose of enteral nutrition will be adjusted dynamically according to the patient's daily metabolic measurements. |
| Standard Nutrition Group | Active comparator | Dietary Supplement: Standard Enteral Nutrition FormulaA standardized enteral nutrition formula will be provided following the routine clinical protocol as recommended by current guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Critically ill patients admitted to the intensive care unit (ICU) who meet the indications for enteral nutrition support.
- Age ≥ 18 years. APACHE II score > 8 at ICU admission. Expected ICU length of stay > 7 days.
Key exclusion criteria (5 listed)
- Age < 18 years. Pregnancy or lactation. Known allergy to any component of the enteral nutrition formula. Gastrointestinal bleeding, incomplete intestinal obstruction, or other conditions precluding full enteral nutrition.
- Known severe thyroid dysfunction (e.g., thyrotoxic crisis, myxedema coma, or uncontrolled hyperthyroidism/hypothyroidism).
- Chronic end-stage organ failure, including: New York Heart Association (NYHA) Class IV heart failure, Child-Pugh Class C cirrhosis, or Stage 5 chronic kidney disease (CKD).
- Primary intestinal diseases (e.g., Crohn's disease, ulcerative colitis, or intestinal malignancies), short bowel syndrome, or history of extensive small bowel resection (residual small intestine < 100 cm).
- Metabolic disorders that significantly affect nutritional metabolism (e.g., Sheehan's syndrome, or other conditions with major metabolic consequences) as determined by the investigator.
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 |
|---|---|---|
| Individualized Enteral Nutrition FormulaIndividualized Enteral Nutrition Formula Based on Daily Metabolic Measurements | Dietary supplement | Individualized Nutrition Group |
| Standard Enteral Nutrition FormulaStandardized enteral nutrition formula will be administered according to the routine clinical protocol recommended by current guidelines. | Dietary supplement | Standard Nutrition Group |
Primary outcome
Length of ICU Stay
Time frame: Up to 90 days
Total number of days from ICU admission to ICU discharge.
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 10 Aug 2026.
- Results publication: PubMed 37324740Xi F, You Y, Ding W, Gao T, Cao Y, Tan S, Yu W. Association of longitudinal changes in skeletal muscle mass with prognosis and nutritional intake in acutely hospitalized patients with abdominal trauma: a retrospective observational study. Front Nutr. 2023 May 31;10:1085124. doi: 10.3389/fnut.2023.1085124. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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 Individualized Enteral Nutrition Formula and Standard Enteral Nutrition Formula in people with Sepsis and Nutrition, run by Chinese Medical Association.
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 2 inclusion and 5 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 10 Aug 2026. 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 Ying Xu, MD (+86 13505159362, xuying.0110@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of ICU Stay (time frame: Up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07755033, which also lists 1 linked publication.
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 10 Aug 2026.