Personalized Nutritional Formula for ICU Patients: A Study on Prognosis and Multidimensional Health Markers

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.

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Key information

Conditions

Sepsis Critical Illness Disease Attributes Gut -Microbiota Infections Inflammation Nutrition Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Individualized Enteral Nutrition Formula

Dietary Supplement

Individualized Enteral Nutrition Formula Based on Daily Metabolic Measurements

Standard Enteral Nutrition Formula

Dietary Supplement

Standardized enteral nutrition formula will be administered according to the routine clinical protocol recommended by current guidelines.

Primary outcomes

Length of ICU Stay

Time frame: Up to 90 days

Total number of days from ICU admission to ICU discharge.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Xu, MD

CONTACT

[email protected]

+86 13505159362

Sponsors and collaborators

Lead sponsor

Chinese Medical Association

Network

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Aug 10, 2026
Registry last updated: Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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