Long-Term Enteral Immunonutrition Containing Lactoferrin in Tube-Fed Bedridden Patients: Immunological and Nutritional Status

Abstract

Objective: The aim of this study was to examine the efficacy and safety of a novel immune-enhancing enteral formula, Prem-8, which contains lactoferrin as an immunonutrient.

Design, Setting, Patients: A multicenter, randomized controlled trial was conducted in 5 hospitals in Japan, and 71 tube-fed bedridden patients with serum albumin concentrations between 2.5 and 3.5 g/dL were allocated to Prem-8 (n = 38) or control formula (n = 33) groups for an observation period of 12 weeks.

Measures of Outcome: Efficacy was evaluated by comparing immunological (natural killer cell activity, neutrophil-phagocytic activity, neutrophil-sterilizing activity, and C-reactive protein), and nutritional (anthropometric measurements and serum levels of nutritional assessment proteins and total cholesterol) variables. Safety was assessed by comparing the incidence of adverse events. In a secondary analysis, patients were subgrouped according to the amount of protein supplemented (1 g/kg/d) so that immunological and nutritional variables and safety could be further compared.

Results: Natural killer activity and neutrophil functions were normal for both groups throughout the study period, without significant between-group differences at any point. Nutritional status was stably maintained in both groups, although the body mass index at 12 weeks was marginally lower in the Prem-8 group than in the control group (p < 0.01). The incidence of adverse events were comparable between both groups, but the incidence of fever in the Prem-8 group (7/14) was significantly lower than in the control group (10/11) in a subgroup of patients whose supplemented protein was less than 1 g/kg/d (p < 0.05).

Conclusion: Prem-8 did not demonstrate superiority to the control formula with respect to immunological and nutritional variables, whereas the body mass index of patients in the Prem-8 group marginally decreased. However, Prem-8 had a favorable effect on the incidence of fever in a subgroup of patients with low protein intake.

Key words:

• immunonutrition
• lactoferrin
• enteral nutrition
• innate immunity

ACKNOWLEDGMENTS

We thank Tomihiro Kawamitsu of Sangenjaya Hospital, Takahiro Matsumoto of Sangenjaya Dai-ichi Hospital, and Osamu Sakamoto and Atsuro Tsuchiya of Ohta-Atami Hospital for the execution of the study. We are grateful to Satoshi Morita, PhD, of Yokohama City University Medical Center for advising us on statistical analysis, and Ryozo Nagai of the University of Tokyo and Kentaro Sugano of Jichi Medical University for study supervision. Morinaga Milk Industry Co Ltd supported us with funding and provided the Prem-8 and the control enteral formula.

Notes

Conflict of interest statement: The authors report a conflict of interest as follows: M.T. is an employee of Morinaga Milk Industry Co, Ltd. Y.T., T.Y., S.T., K.K., S.K., and M.I. report no potential conflict of interest. Morinaga Milk Industry Co, Ltd, supported the authors with funding and provided the Prem-8 and the control enteral formula.