Malnutrition
Conditions
Interventions
A:The standard dietary
B:Abbott-EN nutrition powder
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18-80 years of age; 2. Agree to sign an informed consent form; 3. Elective abdominal (stomach, intestine, liver, gallbladder, pancreas etc.) surgery. For patient with malignant tumour, preoperative Karnofsky Score should be ?70 and life expectancy should be longer than 6 months; 4. Expected hospitalization period of 7-14 days after surgery. 5. Nutritional risk screening (NRS2002) score >=3 points; 6. Post-operative total parental nutrition treatment period is expected to be =<5 days, which is judged by investigator. 7. The urine pregnancy test was negative for women of childbearing age, take effective contraceptive measures during this study; 8. Agree to abstain from consuming other nutritional products concomitantly during the trial, such as protein powder or cow colostrum etc.
Exclusion criteria
Exclusion criteria: 1. The staff or the direct relatives of staff working in the study sites, where the direct relative is defined as the spouse, parents, children or siblings, including both biological or legally adopted; 2. Subjects who decide to withdraw after signing the informed consents forms; 3. Patients enrolled in any other drug or medical device clinical trials within 30 days before being enrolled in this study; 4. Patients with laparoscopic cholecystectomy; 5. Pregnant women or women giving breast-feeding; 6. Patients unable to intake food orally; 7. Patients with intestinal obstruction, intestinal bleeding, severe mal-absorption, severe short bowel syndrome or fistula with significant discharge, severe nausea and vomiting; 8. Patients with severe enteritis or diarrhea; 9. Patients receiving enteral or parenteral nutrition therapy within 2 weeks before Screening; 10. Patients with concomitant severe cardiac disorder, diabetes, hyperlipidemia, electrolyte imbalance, liver and kidney dysfunction, or with other conditions not suitable for participating in the study at the investigator’s discreet. (ALT or AST increases 2.5x upper limit, Creatine > 176 umol/L or 2.0mg/dl); 11. Patients with galactosemia, amino acid metabolism disorders or allergy to cow milk or bean protein; 12. Patients with poor compliance; 13. Patients with other conditions not suitable for participating in the study at the investigator’s discretion; 14. Patients who are currently taking or require to take medications after surgery that could profoundly modulate metabolism or weight (e.g. diuretics, steroids, growth hormone, appetite stimulants); 15. Active tuberculosis, acute phase of Hepatitis B or C and HIV carriers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weigh; | — |
Secondary
| Measure | Time frame |
|---|---|
| biceps circumferenc; | — |
Countries
China
Contacts
Public ContactWei Jun-min
Beijing Hospital
Outcome results
None listed