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Long-term enteral immunonutrition containing lactoferrin in tube-fed bedridden patients: immunological and nutritional status.
MedLine Citation:
PMID:  23204157     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
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.
Authors:
Yoshiaki Takeuchi; Takuya Yamamura; Seiichiro Takahashi; Kozo Katayose; Shin Kohga; Mitsunori Takase; Michio Imawari
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of the American College of Nutrition     Volume:  31     ISSN:  1541-1087     ISO Abbreviation:  J Am Coll Nutr     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-12-03     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8215879     Medline TA:  J Am Coll Nutr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  206-13     Citation Subset:  IM    
Affiliation:
Department of Gastroenterology, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, JAPAN. yoshtake@med.showa-u.ac.jp.
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