[The role of immune enhanced enteral nutrition on plasma amino acid, gut permeability and clinical outcome (a randomized, double blind, controlled, multi-center clinical trail with 120 cases)].

OBJECTIVE: To evaluate the role of arginine, RNA and omega 3 fatty acid enriched enteral nutrition.
METHODS: The study was designed as a prospective, randomized, double blind, multi-central trial. It was an isocaloric and isonitrogenous intake in both groups. The protocol was approved by the Ethic Committee and, written informed consents were obtained.
RESULTS: There were 120 patients enrolled in this protocol. After data were input to computer, open the code. 118 out of 120 patients completed the study and, 2 of them were dropped out. One is because the nasal jejunum tubes dropped and not willing to be replaced. Second patient had fistula of anastomosis on 4th days after operation. There were finally 60 patients in the study group and 58 in the control group. There were no liver or renal functions damage and, obvious adverse in both groups. Plasma amino acid profile: There was significant difference (delta) of plasma arginine levels pre- and after study [(33.7 +/- 58.5) mumol/L vs (-2.4 +/- 30.7) mumol/L] (P = 0.004). Intestinal Permeability (lactulose/mannitol ratio): The differences (delta) of lactulose/mannitol ratio pre- and after the study were 0.017 +/- 0.012 in study group and, 0.027 +/- 0.016 in control group. (P = 0.047). Immunological markers: Humoral immunity: The differences of IgM levels pre- and after the study were (0.6 +/- 0.4) g/L in study group and, (0.2 +/- 0.4) g/L in control group(P = 0.006). Cellular immunity: The differences (delta) of CD3 levels pre- and after the study were (3.8 +/- 5.2)% in study group and (0.3 +/- 6.5)% in control group (P = 0.01). In CD4, (3.4 +/- 5.3)% in study group and, (-0.3 +/- 5.7)% in control group (P = 0.032). Clinical Outcomes: There was no infection-related in study group and, 2 abdominal infection patients in control group. No significant difference was found between groups (P = 0.46). The hospital stays were (13 +/- 2.5) days in study group and, (14.5 +/- 3.0) days in control group (P = 0.004). The cost for full hospitalization was (15,122 +/- 6,279) Yuan in study group and, (17,403 +/- 7,091) Yuan in control group. There was 2,281 Yuan lower in study group (P = 0.07). The costs for nutritional drugs were (1,383 +/- 242) Yuan in study group and, (707 +/- 111) Yuan in control group. The difference was 676 Yuan higher in study (P = 0.001).
CONCLUSION: Immune enhanced enteral nutrition had better plasma arginine level, intestinal permeability marker, IgM, CD3 and CD4. Also had less hospital stay and, less totaled hospital cost in study group.

RCT Entities:   Population Interventions Outcomes