Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Enteral immunonutrition (EIN) has been gaining increasing attention, but data of its immune and anti-inflammatory function in patients undergoing gastrectomy for gastric cancer are poorly investigated. The aim of this study was to assess the effect of EIN on immune function, inflammation response and nutrition status when compared to standard enteral nutrition (SEN).
The investigators believe that the proportion of cluster of differentiation 4 T-cells(CD4＋T-cells), cluster of differentiation 3 T-cells(CD3＋T-cells) and the counts of CD4＋ / cluster of differentiation 8 T-cells (CD8＋), immunoglobulin G(IgG), immunoglobulin M(IgM), and immunoglobulin A (IgA) were larger in EIN group, while the level of WBC, CRP and TNF-α were lower and nutritional status was similar.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EIN group | Experimental | Enteral formula including not only basic energy components, but also immune components such as omega-3 fatty acids, glutamine (Gln), arginine (Arg), and nucleotide. |
|
| SEN group | Active Comparator | Enteral formula including only basic energy components. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enteral immunonutrition | Dietary Supplement | Enteral nutrition was started within 12h at an infusion rate of 20ml per hour for SEN group and 16ml per hour for EIN group in the first 24h. The rates of flow were gradually increasing with 50ml/h in SEN versus 40ml/h in EIN on day 2, 70ml/h versus 56ml/h on day 3 and 100ml/h versus 80ml/h until the 7th day depending on the feeding tolerance. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline serum level of immune cytokines to postoperative day 5 | levels of IgA, IgG and IgM in g/L, | baseline and postoperative day 5 |
| Change from baseline serum level of immune markers to postoperative day 5 | count of CD4＋/CD8＋ | baseline, postoperative day 5(POD 5) |
| Change from baseline serum concentration of immune markers to postoperative day 5 | percentage of CD3＋ T cell of serum | baseline, postoperative day 5(POD 5) |
| Measure | Description | Time Frame |
|---|---|---|
| changes among baseline, postoperative day 1, 3 and 5 serum concentration of inflammatory markers | concentration of white blood cell (WBC), C-reactive protein (CRP), interleukin-6 (IL-6) in g/L, and levels of tumor necrosis factor-α (TNF-α) in ng/L | baseline, postoperative day 1, 3, and 5 |
| Change among baseline, postoperative day 3 and 5 serum nutritional markers |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Patients were randomized to receive enteral immunonutrition or standard enteral nutrition in postoperative day 1 by enteral feeding.
Not provided
Not provided
Eligible patients were randomly assigned in equal numbers to undergo SEN or EIN according to a computer-generated randomization list managed by a dietary nurse not involved in the study. The study was double-blind: SEN and EIN feeds were identical in color and type of container, so treatment assignments were not revealed to patients or to any staff members.
|
concentration of albumin, prealbumin, and transferrin in g/L |
| baseline,postoperative day 3 and 5 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided