Methods for diagnosing irritable bowel syndrome
AssigneePrometheus Laboratories Inc.
InventorAugusto Lois
Life of this patent
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Abstract
The present invention provides methods, systems, and code for accurately classifying whether a sample from an individual is associated with irritable bowel syndrome (IBS). In particular, the present invention is useful for classifying a sample from an individual as an IBS sample using a statistical algorithm and/or empirical data. The present invention is also useful for ruling out one or more diseases or disorders that present with IBS-like symptoms and ruling in IBS using a combination of statistical algorithms and/or empirical data. Thus, the present invention provides an accurate diagnostic prediction of IBS and prognostic information useful for guiding treatment decisions.
Claims51
A method for classifying whether a sample from an individual is associated with irritable bowel syndrome (IBS), said method comprising:
- (a) determining a diagnostic marker profile by detecting the presence or level of at least one diagnostic marker selected from the group consisting of a cytokine, growth factor, anti-neutrophil antibody, anti-Saccharomyces cerevisiae antibody (ASCA), antimicrobial antibody, lactoferrin, anti-tissue transglutaminase (tTG) antibody, lipocalin, matrix metalloproteinase (MMP), tissue inhibitor of metalloproteinase (TIMP), alpha-globulin, actin-severing protein, S100 protein, fibrinopeptide, calcitonin gene-related peptide (CGRP), tachykinin, ghrelin, neurotensin, corticotropin-releasing hormone, and combinations thereof in said sample;
- and
- (b) classifying said sample as an IBS sample or non-IBS sample using an algorithm based upon said diagnostic marker profile.
A method for monitoring the progression or regression of irritable bowel syndrome (IBS) in an individual, said method comprising:
- (a) determining a diagnostic marker profile by detecting the presence or level of at least one diagnostic marker selected from the group consisting of a cytokine, growth factor, anti-neutrophil antibody, anti-Saccharomyces cerevisiae antibody (ASC), antimicrobial antibody, lactoferrin, anti-tissue transglutaminase (tTG) antibody, lipocalin, matrix metalloproteinase (MMP), tissue inhibitor of metalloproteinase (TIMP), alpha-globulin, actin-severing protein, S100 protein, fibrinopeptide, calcitonin gene-related peptide (CGRP), tachykinin, ghrelin, neurotensin, corticotropin-releasing hormone, and combinations thereof in said sample;
- and
- (b) determining the presence or severity of IBS in said individual using an algorithm based upon said diagnostic marker profile.
A method for monitoring drug efficacy in an individual receiving a drug useful for treating irritable bowel syndrome (IBS), said method comprising:
- (a) determining a diagnostic marker profile by detecting the presence or level of at least one diagnostic marker selected from the group consisting of a cytokine, growth factor, anti-neutrophil antibody, anti-Saccharomyces cerevisiae antibody (ASC), antimicrobial antibody, lactoferrin, anti-tissue transglutaminase (tTG) antibody, lipocalin, matrix metalloproteinase (MMP), tissue inhibitor of metalloproteinase (TIMP), alpha-globulin, actin-severing protein, S100 protein, fibrinopeptide, calcitonin gene-related peptide (CGRP), tachykinin, ghrelin, neurotensin, corticotropin-releasing hormone, and combinations thereof in said sample;
- and
- (b) determining the effectiveness of said drug using an algorithm based upon said diagnostic marker profile.
A computer-readable medium comprising code for controlling one or more processors to classify whether a sample from an individual is associated with irritable bowel syndrome (IBS), said code comprising:
- instructions to apply a statistical process to a data set comprising a diagnostic marker profile to produce a statistically derived decision classifying said sample as an IBS sample or non-IBS sample based upon said diagnostic marker profile,
- wherein said diagnostic marker profile indicates the presence or level of at least one diagnostic marker selected from the group consisting of a cytokine, growth factor, anti-neutrophil antibody, anti-Saccharomyces cerevisiae antibody (ASC), antimicrobial antibody, lactoferrin, anti-tissue transglutaminase (tTG) antibody, lipocalin, matrix metalloproteinase (MMP), tissue inhibitor of metalloproteinase (TIMP), alpha-globulin, actin-severing protein, S100 protein, fibrinopeptide, calcitonin gene-related peptide (CGRP), tachykinin, ghrelin, neurotensin, corticotropin-releasing hormone, and combinations thereof in said sample.
A system for classifying whether a sample from an individual is associated with irritable bowel syndrome (IBS), said system comprising:
- (a) a data acquisition module configured to produce a data set comprising a diagnostic marker profile, wherein said diagnostic marker profile indicates the presence or level of at least one diagnostic marker selected from the group consisting of a cytokine, growth factor, anti-neutrophil antibody, anti-Saccharomyces cerevisiae antibody (ASC), antimicrobial antibody, lactoferrin, anti-tissue transglutaminase (tTG) antibody, lipocalin, matrix metalloproteinase (MMP), tissue inhibitor of metalloproteinase (TIMP), alpha-globulin, actin-severing protein, S100 protein, fibrinopeptide, calcitonin gene-related peptide (CGRP), tachykinin, ghrelin, neurotensin, corticotropin-releasing hormone, and combinations thereof in said sample;
- (b) a data processing module configured to process the data set by applying a statistical process to the data set to produce a statistically derived decision classifying said sample as an IBS sample or non-IBS sample based upon said diagnostic marker profile;
- and
- (c) a display module configured to display the statistically derived decision.
Dependencies are inferred from the claim text.