title: Alleviation of insulin resistance and liver damage by oral administration of Imm124-E is mediated by increased Tregs and associated with increased serum GLP-1 and adiponectin: results of a phase I/II clinical trial in NASH.
abstract: BACKGROUND
  Nonalcoholic steatohepatitis (NASH) is considered to be part of the nonalcoholic fatty liver disorders and its incidence is increasing. Imm124-E (Immuron Ltd, Melbourne, Australia), containing hyperimmune bovine colostrum, has been shown to exert an immunomodulatory effect and to alleviate target organ damage in animal models of NASH. The aim of our study was to determine the safety and efficacy of oral administration of Imm124-E to patients with insulin resistance and NASH.
  
  
  METHODS
  In an open-label trial, ten patients with biopsy-proven NASH and insulin resistance were orally treated with Imm124-E for 30 days.
  
  
  RESULTS
  Oral administration of Imm124-E was safe, and no side effects were noted. Alleviation of insulin resistance was reflected by significantly improved hemoglobin A(1c) (HbA(1c)) values in all ten treated patients. For between five and eight responders, the following effects were noted: a decrease in fasting glucose levels; improved oral glucose tolerance test (OGGT) and homeostatic model assessment insulin resistance (HOMA) scores; and alleviation in lipid profile. These effects were accompanied by increased serum levels of glucagon-like peptide 1 (GLP-1), adiponectin and T regulatory cells.
  
  
  CONCLUSIONS
  Hyperimmune colostrum alleviates NASH.
authors.affiliation: Liver Unit, Hebrew University-Hadassah Medical Center, Jerusalem, Israel.
authors.forename: Meir
authors.initials: M
authors.lastname: Mizrahi
authors.forename: Yehudit
authors.initials: Y
authors.lastname: Shabat
authors.forename: Ami
authors.initials: A
authors.lastname: Ben Ya'acov
authors.forename: Gadi
authors.initials: G
authors.lastname: Lalazar
authors.forename: Tomer
authors.initials: T
authors.lastname: Adar
authors.forename: Victor
authors.initials: V
authors.lastname: Wong
authors.forename: Brian
authors.initials: B
authors.lastname: Muller
authors.forename: Grant
authors.initials: G
authors.lastname: Rawlin
authors.forename: Yaron
authors.initials: Y
authors.lastname: Ilan
keywords: NASH; adipokines; anti-LPS; diabetes; regulatory T cells