An interventional study of Individualized Enteral Nutrition Formula and Standard Enteral Nutrition Formula in Sepsis, Nutrition and Gut -Microbiota, sponsored by Chinese Medical Association. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Chinese Medical Association · Not applicable, Interventional, and Treatment
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Chinese Medical Association is the lead sponsor of 40 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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: (NYHA) Class IV heart failure, Class C cirrhosis, or Stage 5 chronic kidney disease (CKD).
Primary intestinal diseases (e.g., Crohn's disease, ulcerative colitis, or intestinal ), 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The total daily dose of enteral nutrition will be adjusted dynamically according to the patient's daily metabolic measurements.
Dietary Supplement: Individualized Enteral Nutrition Formula
A standardized enteral nutrition formula will be provided following the routine clinical protocol as recommended by current guidelines.
Dietary Supplement: Standard Enteral Nutrition Formula
Individualized Enteral Nutrition Formula Based on Daily Metabolic Measurements
Standardized enteral nutrition formula will be administered according to the routine clinical protocol recommended by current guidelines.
Length of ICU Stay
Total number of days from ICU admission to ICU discharge.
Time frame: Up to 90 days
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jul 2026; primary completion for Jul 2027, 11 months later.
Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 11 months is below that.
Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Chinese Medical Association