title: 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.
  
  
  METHODS
  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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gastroenterology, Showa University School of Medicine, Tokyo, Japan. yoshtake@med.showa-u.ac.jp
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Takeuchi
authors.forename: Takuya
authors.initials: T
authors.lastname: Yamamura
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Takahashi
authors.forename: Kozo
authors.initials: K
authors.lastname: Katayose
authors.forename: Shin
authors.initials: S
authors.lastname: Kohga
authors.forename: Mitsunori
authors.initials: M
authors.lastname: Takase
authors.forename: Michio
authors.initials: M
authors.lastname: Imawari
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000494:pharmacology*; D001510:Bed Rest; D015992:Body Mass Index; D002097:C-Reactive Protein / Q000276:immunology; D004044:Dietary Proteins / Q000008:administration & dosage; D004750:Enteral Nutrition / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005334:Fever / Q000453:epidemiology*; D005526:Food, Formulated; D006801:Humans; D007564:Japan; D007694:Killer Cells, Natural / Q000276:immunology; D007781:Lactoferrin / Q000009:adverse effects / Q000276:immunology / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D009504:Neutrophils / Q000276:immunology; D009752:Nutritional Status; D012709:Serum Albumin / Q000378:metabolism
chemical_list: D000890:Anti-Infective Agents; D004044:Dietary Proteins; D012709:Serum Albumin; D002097:C-Reactive Protein; D007781:Lactoferrin