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US 7,923,000 B2Granted
Methods of determining efficacy of treatments of inflammatory diseases of the bowel
AssigneeThe Procter & Gamble Company
InventorsKer-Sang Chen, John Kevin Collins, Barry Pius Kiely, Fangyi Luo, Liam Diarmuid O'Mahony, Ross Peter Phillipson, Fergus Shanahan
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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.
Claims21
A method of determining the efficacy of a probiotic as a treatment of irritable bowel syndrome in mammals in vivo comprising the steps of:
- a) measuring the level of at least one anti-inflammatory cytokine selected from the group consisting of interleukin-10, transforming growth factor-β, interleukin-4, interleukin-5, interleukin-13, and combinations thereof and at least one pro-inflammatory cytokine selected from the group consisting of interleukin-12, tumour necrosis factor-α, interferon-γ, interleukin-2, and combinations thereof in a supernatant from cells cultured from a biological sample from a mammalian subject wherein said biological sample is selected from the group consisting of a biopsy sample from the bowel, peripheral blood mononuclear cells without in vitro stimulation, peripheral blood mononuclear cells with in vitro stimulation, gut lymphoid tissues without in vitro stimulation, gut lymphoid tissues with in vitro stimulation, and combinations thereof;
- b) determining the ratio of the level of the at least one anti-inflammatory cytokine to the level of the at least one pro-inflammatory cytokine;
- c) administering said treatment;
- d) measuring the level of the at least one anti-inflammatory cytokine and the at least one pro-inflammatory cytokine in a supernatant from cells cultured from a biological sample from said mammalian subject at a time following administration of said treatment;
- e) determining the ratio of the level of the at least one anti-inflammatory cytokine to the level of the at least one pro-inflammatory cytokine following administration of said treatment;
- wherein an increase in the ratio of the levels of anti-inflammatory cytokine to pro-inflammatory cytokine following the administration of said treatment is indicative of the efficacy of said treatment for irritable bowel syndrome, and no change or a decrease in the ratio of the levels of anti-inflammatory to pro-inflammatory cytokine following the administration of said treatment is indicative of lack of efficacy of said treatment for irritable bowel syndrome.
3 more elements
A method of determining the efficacy of a probiotic as a treatment of irritable bowel syndrome in humans in vivo comprising the steps of:
- f) measuring the level of at least one anti-inflammatory cytokine selected from the group consisting of interleukin-10, transforming growth factor-β, interleukin-4, interleukin-5, interleukin-13, and combinations thereof and at least one proinflammatory cytokine selected from the group consisting of interleukin-12, tumour necrosis factor-α, interferon-γ, interleukin-2, and combinations thereof in a supernatant from cells cultured from a biological sample from a human subject wherein said biological sample is selected from the group consisting of a biopsy sample from the bowel, peripheral blood mononuclear cells without in vitro stimulation, peripheral blood mononuclear cells with in vitro stimulation, gut lymphoid tissues without in vitro stimulation, gut lymphoid tissues with in vitro stimulation, and combinations thereof;
- g) determining the ratio of the level of the at least one anti-inflammatory cytokine to the level of the at least one pro-inflammatory cytokine;
- h) administering said treatment;
- i) measuring the level of the at least one anti-inflammatory cytokine and the at least one pro-inflammatory cytokine in a supernatant from cells cultured from a biological sample from said human subject at a time following administration of said treatment;
- j) determining the ratio of the level of the at least one anti-inflammatory cytokine to the level of the at least one pro-inflammatory cytokine following administration of said treatment;
- wherein an increase in the ratio of the levels of anti-inflammatory cytokine to pro- inflammatory cytokine following the administration of said treatment is indicative of the efficacy of said treatment for irritable bowel syndrome, and no change or a decrease in the ratio of the levels of anti-inflammatory to pro-inflammatory cytokine following the administration of said treatment is indicative of lack of efficacy of said treatment for irritable bowel syndrome.
3 more elements
Dependencies are inferred from the claim text.