Bifidobacterium in the treatment of inflammatory disease

Abstract

A strain of Bifidobacterium isolated from resected and washed human gastrointestinal tract is significantly immunomodulatory following oral consumption in humans. The strain is useful in the prophylaxis and/or treatment of undesirable inflammatory activity, especially gastrointestinal inflammatory activity such as inflammatory bowel disease or irritable bowel syndrome. The inflammatory activity may also be due to cancer.

1 - 54 . (canceled) 
   
   
       55 . A biologically pure culture of a strain of  Bifidobacterium  isolated from a resected and washed human gastrointestinal tract, wherein the strain of  Bifidobacterium  secretes a factor that antagonizes the activity of at least one pro-inflammatory cytokine. 
   
   
       56 . The biologically pure culture of a strain of  Bifidobacterium  according to  claim 55  wherein the pro-inflammatory cytokine is selected from one or both of TNF-α and IL-8. 
   
   
       57 . The biologically pure culture of a strain of  Bifidobacterium  according to  claim 55 , wherein the strain of  Bifidobacterium  is bile resistant and grows in the presence of physiologically relevant human bile. 
   
   
       58 . The biologically pure culture of a strain of  Bifidobacterium  according to  claim 55 , wherein the strain of  Bifidobacterium  is significantly immunomodulatory following oral consumption in humans, as evidenced by a decrease in systemic levels of at least one pro-inflammatory cytokine in humans. 
   
   
       59 . The biologically pure culture of a strain of  Bifidobacterium  according to  claim 58 , wherein the pro-inflammatory cytokine is selected from one or more of TNF-α, IL-8, sIL-6R and IFNγ. 
   
   
       60 . The biologically pure culture of a strain of  Bifidobacterium  according to  claim 58 , wherein the immunomodulatory effect is an increase in an anti-inflammatory cytokine; a decrease in a pro-inflammatory cytokine; an increase in an anti-inflammatory cytokine and a decrease in a pro-inflammatory cytokine; or production of a high anti-inflammatory cytokine to pro-inflammatory cytokine ratio in the human following oral consumption. 
   
   
       61 . The biologically pure culture of a strain of  Bifidobacterium  according to  claim 58 , wherein the strain inhibits the growth of Gram positive bacteria, Gram negative bacteria, or both. 
   
   
       62 . The biologically pure culture of a strain of  Bifidobacterium  according to  claim 58 , wherein the strain inhibits the growth of  Staphylcoccus  spp.,  Pseudomonas  spp.,  Coliform  spp.,  Bacillus  spp., or a combination thereof. 
   
   
       63 . The biologically pure culture of a strain according to  claim 58 , wherein the strain of  Bifidobacterium  comprises  Bifidobacterium longum infantis.    
   
   
       64 . The biologically pure culture of a strain of  Bifidobacterium  according to  claim 58 , wherein the strain is  Bifidobacterium longum infantis  UCC35624 or a mutant or a variant thereof. 
   
   
       65 . The biologically pure culture of a strain according to  claim 64 , wherein the strain of  Bifidobacterium  comprises  Bifidobacterium longum infantis  UCC35624. 
   
   
       66 . The biologically pure culture of a strain of  Bifidobacterium  according to  claim 64 , wherein the mutant is a genetically modified mutant, the variant may be a naturally occurring variant. 
   
   
       67 . The biologically pure culture of a strain of  Bifidobacterium  according to  claim 58 , wherein the strain is in the form of viable cells, or non-viable cells. 
   
   
       68 . The biologically pure culture of a strain of  Bifidobacterium  according to  claim 58 , wherein the strain of  Bifidobacterium  is immunomodulatory to substantially the same extent as  Bifidobacterium longum infantis  UCC35624. 
   
   
       69 . A formulation comprising the biologically pure culture of a strain of  Bifidobacterium  isolated from a resected and washed human gastrointestinal tract, wherein the strain of  Bifidobacterium  secretes a factor that antagonizes the activity of at least one pro-inflammatory cytokine. 
   
   
       70 - 86 . (canceled) 
   
   
       87 . A foodstuff comprising the formulation of  claim 69 . 
   
   
       88 . A pharmaceutical composition comprising the  Bifidobacterium  strain of  claim 58  and a pharmaceutically acceptable carrier. 
   
   
       89 . A pharmaceutical composition comprising the formulation of  claim 69  and a pharmaceutically acceptable carrier. 
   
   
       90 - 93 . (canceled) 
   
   
       94 . A method of treating or preventing inflammation or an inflammatory disease in a human in need thereof by administering to the human a composition consisting essentially of a  Bifidobacterium  strain, wherein the  Bifidobacterium  strain is isolated from a resected and washed human gastrointestinal tract and produces a decrease in systemic levels of at least one pro-inflammatory cytokine in humans following oral consumption. 
   
   
       95 . A method of treating or preventing inflammation or an inflammatory disease in a human in need thereof, by administering to the human a formulation consisting essentially of a strain of  Bifidobacterium , wherein the  Bifidobacterium  strain is isolated from a resected and washed human gastrointestinal tract and produces a decrease in systemic levels of at least one pro-inflammatory cytokine in humans following oral consumption.