title: Dietary Supplementation with a Combination of Lactoferrin, Fish Oil, and Enterococcus faecium WB2000 for Treating Dry Eye: A Rat Model and Human Clinical Study.
abstract: To examine the effect of a combined dietary supplement containing fish oil, lactoferrin, zinc, vitamin C, lutein, vitamin E, γ-aminobutanoic acid, and Enterococcus faecium WB2000 on dry eye.
  
  
  
  A preliminary study in a rat model and a prospective, randomized, double-blind, placebo-controlled study in humans were conducted. Forty Japanese volunteers aged 22 to 59 years were randomized into combined dietary supplement (2 capsules/day; 20 participants) and placebo (vehicle; 19 participants) groups and treated once daily for 8 weeks. Rats received the combined dietary supplement components (10 or 50 mg/kg orally) or vehicle (2% DMSO), and dry eye was mechanically induced for 2 days. Tear production was measured in rats after dry eye was induced. Humans were assessed at baseline and weeks 4 and 8 post-supplementation based on keratoconjunctival epithelial damage; fluorescein tear film breakup time; tear production; biochemical data; information regarding subjective dry eye symptoms by answering a questionnaire; and information regarding adverse events via medical interviews.
  
  
  
  Supplementation dose-dependently mitigated the decrease in tear production in rats. Among subjects with confirmed dry eye, clinical symptoms improved at weeks 4 and 8 more significantly in the supplementation group than in the placebo group (P<.05). The rate of increase in the Schirmer value was greater in the supplementation group. No adverse events occurred.
  
  
  
  Supplementation improved objective and subjective dry eye symptoms.
authors.affiliation: Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan. Electronic address: motoko-k@a3.keio.jp.
authors.forename: Motoko
authors.initials: M
authors.lastname: Kawashima
authors.affiliation: Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Nakamura
authors.affiliation: Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Izuta
authors.affiliation: Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan; Haneginomori Eye Clinic, Tokyo, Japan.
authors.forename: Sachiko
authors.initials: S
authors.lastname: Inoue
authors.affiliation: Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Tsubota
mesh_terms: D000328:Adult; D000818:Animals; D019587:Dietary Supplements; D004311:Double-Blind Method; D015352:Dry Eye Syndromes; D016984:Enterococcus faecium; D005395:Fish Oils; D006801:Humans; D007781:Lactoferrin; D008875:Middle Aged; D011446:Prospective Studies; D051381:Rats; D013666:Tears; D055815:Young Adult
chemical_list: D005395:Fish Oils; D007781:Lactoferrin
keywords: Schirmer test; dietary supplements; dry eye; tears