Methods of determining efficacy of treatments of diseases of the bowel

Abstract

Novel methods of determining efficacy of a treatment of inflammatory diseases of the bowel in mammals are provided. The methods are of use in screening and determining the efficacy of treatments of inflammatory diseases of the bowel, and for determining the efficacy response of individual sufferers of inflammatory diseases of the bowel to a given regime. Kits for carrying out the method are also provided.

What is claimed is: 
     
         1 . A kit for screening compositions for efficacy of a probiotic in the treatment of irritable bowel syndrome comprising a first measuring element or system for measuring at least one anti-inflammatory cytokine in a biological sample comprising a gut-derived cell type, a second measuring element or system for measuring at least one pro-inflammatory cytokine in a biological sample comprising a gut-derived cell type, wherein the difference in ratio of anti-inflammatory to pro-inflammatory cytokine between a control sample and a treated sample that has been stimulated with a composition can be determined, and that a ratio of anti-inflammatory cytokine to said pro-inflammatory cytokine greater than the control is indicative of an inhibitor of irritable bowel syndrome. 
     
     
         2 . The kit according to  claim 1 , wherein the anti-inflammatory cytokine is selected from the group comprising interleukin-10, transforming growth factor-β, interleukin-4, interleukin-5, interleukin-13, and mixtures thereof. 
     
     
         3 . The kit according to  claim 2 , wherein the anti-inflammatory cytokine is selected from the group comprising interleukin-10, transforming growth factor-β, and mixtures thereof. 
     
     
         4 . The kit according to  claim 1 , wherein the pro-inflammatory cytokine comprises interleukin-12, tumour necrosis factor-α, interferon-γ, interleukin-2, and mixtures thereof. 
     
     
         5 . The kit according to  claim 4 , wherein the pro-inflammatory cytokine comprises interleukin-12, tumour necrosis factor-α, interferon-γ, and mixtures thereof. 
     
     
         6 . The kit according to  claim 1 , wherein said ratio of anti-inflammatory cytokine to pro-inflammatory cytokine is the ratio interleukin-10/interleukin-12. 
     
     
         7 . The kit according to  claim 1 , wherein said ratio of anti-inflammatory cytokine to pro-inflammatory cytokine is the ratio transforming growth factor-β/interleukin-12. 
     
     
         8 . The kit according to  claim 1 , wherein said ratio of anti-inflammatory cytokine to pro-inflammatory cytokine is the ratio interleukin-10/interferon-γ. 
     
     
         9 . The kit according to  claim 1 , wherein said biological sample comprises urine, plasma, serum, saliva, tissue biopsies, cerebrospinal fluid, peripheral blood mononuclear cells with in vitro stimulation, peripheral blood mononuclear cells without in vitro stimulation, gut lymphoid tissues with in vitro stimulation, gut lymphoid tissues without in vitro stimulation, gut lavage fluids, and mixtures thereof. 
     
     
         10 . The kit according to  claim 9 , wherein said biological sample comprises serum, peripheral blood mononuclear cells with in vitro stimulation, peripheral blood mononuclear cells without in vitro stimulation, and mixtures thereof. 
     
     
         11 . The kit according to  claim 10 , wherein said biological sample comprises peripheral blood mononuclear cells with in vitro stimulation, peripheral blood mononuclear cells without in vitro stimulation, and mixtures thereof. 
     
     
         12 . The kit according to  claim 1 , wherein said treated sample is stimulated with a mitogen, probiotic, anti-CD3 molecule, or mixtures thereof. 
     
     
         13 . The kit according to  claim 12 , wherein said treated sample is stimulated with a mitogen. 
     
     
         14 . The kit according to  claim 13 , wherein said mitogen comprises a lipopolysaccharide, lectin, superantigen, and mixture thereof. 
     
     
         15 . The kit according to  claim 14 , wherein said lectin comprises concanavalin A, phytohemagglutinin, pokeweed mitogen, and mixtures thereof. 
     
     
         16 . The kit according to  claim 1 , wherein said kit further comprises means for obtaining said biological samples before and after treatment.