The present invention provides a genus of polycyclic amines that are useful as opioid receptor modulators. The compounds of the invention are useful in both therapeutic and diagnostic methods, including for treating pain, neurological disorders, cardiac disorders, bowel disorders, drug and alcohol addiction, drug overdose, urinary disorders, respiratory disorders, sexual dysfunction, psoriasis, graft rejection or cancer.

The present invention provides a genus of polycyclic amines that are useful as opioid receptor modulators. The compounds of the invention are useful in both therapeutic and diagnostic methods, including for treating pain, neurological disorders, cardiac disorders, bowel disorders, drug and alcohol addiction, drug overdose, urinary disorders, respiratory disorders, sexual dysfunction, psoriasis, graft rejection or cancer.

The present invention relates to methods and compositions for diagnosing, monitoring, prognosticating, analyzing, etc., polymicrobial diseases. The present invention also relates to the microbial community present in the digestive tract and lumen in normal subjects, and subjects with digestive tract diseases, especially diseases of the colon, such as inflammatory bowel disease, including ulcerative colitis, Crohn's syndrome, and pouchitis. The present invention especially relates to compositions and methods for diagnosing and prognosticating the mentioned diseases and conditions, e.g., to determine the presence of the disease in a subject, to determine a therapeutic regimen, to determine the onset of active disease, to determine the predisposition to the disease, etc.

This invention is related to the area of characterization of inflammation in relation with the gut microbiota, in metabolic and autoimmune disorders. In particular, it relates to the identification of gene signatures which can be used as a marker predictive of inflammation associated diseases, such as liver-related metabolic disorders, in particular to the evolution of benign steatosis towards its most severe forms (steatohepatitis and cirrhosis) or autoimmune disorders, in particular inflammatory bowel diseases (Crohn's and Ulcerative Colitis). These gene signatures can therefore be used as a means of diagnosis, prognosis, stratification for drug studies, for monitoring patient and for assigning an appropriate treatment.

The invention relates to methods of analysing a sample from a subject having or suspected of having Crohn's disease for the abundance of the subject's nucleic acid (e.g., DNA) in the sample. The invention also relates to methods for measuring abundance of nucleic acid (e.g., DNA) in stool from a human subject having or suspected of having Crohn's Disease (CD). In various embodiments, an in vitro method includes analysing the relative abundance of the host (human) DNA in said sample of stool or nucleic acid extracted or isolated from a stool sample from the host (human); determining the relative abundance of the host (human's) DNA in the sample; and associating the abundance of the host (human) DNA with the host (human) providing the stool sample, or the host (human) providing the stool sample from which the nucleic acid was extracted.

The present invention relates to the use of components of the IL23 pathway as biomarkers, e.g., IL22, LCN2 and combinations thereof, to stratify or identify populations of patients suffering from IL23-mediated diseases (e.g., Crohn's disease) responsive to treatment with an anti-IL23 antagonist (including, e.g., anti-IL23 antibodies or antigen-binding fragments thereof). Levels of IL23 pathway biomarkers above or below a predetermined threshold can be used, for example, (i) to determine whether a patient with an IL23-mediated disease or disorder such a Crohn's disease is eligible or non-eligible for treatment with a therapeutic agent (e.g., an ant-IL23 antibody), (ii) to determine whether treatment with a certain agent should be commenced, suspended, or modified, (iii) to diagnose whether the IL23-mediated disease is treatable or not treatable with a specific therapeutic agent, or (iv) to predict the outcome of treating the IL23-mediated disease with a specific therapeutic agent.

The present invention provides antibodies and methods for preparing antibodies to metabolites in the serotonin, tryptophan, kynurenine pathways. The prepared antibodies have low cross-reactivity to related metabolites, and are useful reagents for specific and 5 sensitive immunoassays The present invention also provides stable derivatives of various metabolites and short chain fatty acids. The derivative can be conjugated to a biomolecule such as a carrier protein and combined with an adjuvant to stimulate an immune response. The derivatives can also be conjugated to other biomolecules.

Described herein are methods of detecting levels hydrogen sulfide (H2S) to diagnose H2S positive disease or conditions. Examples of H2S positive diseases and conditions include small intestinal bacterial overgrowth, diarrhea, fatigue, bowel urgency and abdominal pain. The H2S level can guide treatments for subjects who have high levels of H2S.

The present invention relates to humanized antibodies that specifically bind a polypeptide comprising peptide-6 as denoted by SEQ ID NO. 15, that is an HSP65 derived peptide. More specifically, the invention relates to humanized anti-peptide-6 antibodies, compositions, methods and uses thereof for the treatment of immune-related disorders, specifically, inflammatory disorders such as arthritis, IBD, psoriasis, diabetes and MS. The invention further provides combined compositions and kit combining the humanized antibodies of the invention and at least one anti-inflammatory agent, as well as uses of the humanized antibodies in diagnostic kits and methods.

Embodiments provide methods and compositions related to detecting neoplasia in ulcerative colitis patients by detection and analysis of the methylation state of miR-124, miR-137 and/or miR-34b/c in samples from UC patients.

This present invention relates to the use of eicosapentaenoic acid (EPA) for the treatment of ulcerative colitis (UC), and more particularly, the use of highly purified eicosapentaenoic acid as free fatty acids (EPA-FFA) having a purity of at least 95% for reducing inflammation in a subject suffering from ulcerative colitis and wherein the levels of IL-10 and SOCS3 are increased and the microbiome of the intestinal mucosal tissue is favorably modulated.

Described herein are methods and compositions related to the discovery of associations in TNFSF15 15 and DcR3 genetic loci across in Caucasian, Puerto Rican, and Korean Crohn's Disease, as demonstrated via trans-ethnic fine mapping. The present invention provides methods of quantifying risk and diagnosing susceptibility to Crohn's disease in a subject by determining the presence of one or more risk variants are at the TNFSF15 (or TL1A) and/or DcR3 genetic loci.

Methods for preventing IBS, reducing the likelihood of developing IBS and/or treating IBS by administering COT inhibitors and/or COT neutralizers to a subject in need thereof are described. Methods of eliciting a specific immune response and methods of vaccinating a subject to prevent IBS or to reduce the likelihood of developing or having IBS are also provided. Methods of diagnosing IBS by detecting the presence or absence of COT or a COT marker in a subject are described.

Specific binding members, in particular human anti-IL-13 antibody molecules and especially those which neutralize IL-13 activity. Methods for using anti-IL-13 antibody molecules in diagnosis or treatment of IL-13 related disorders, including asthma, atopic dermatitis, allergic rhinitis, fibrosis, inflammatory bowel disease and Hodgkin's lymphoma.

The present disclosure provides methods of using certain biomarker expression profiles in the detection, diagnosis, prognosis, or development of treatment regimens for various cellular hyperproliferative disorders of the bowel. For example, pre-diagnostic methods comprise detecting whether the concentration of at least BAG4 in a test biological sample from a subject is elevated as compared to a control.

Identification of autoantibodies associated with Crohn's disease useful in diagnosis and management using an innovative protein array technology, namely nucleic acid programmable protein arrays (NAPPA) and applications relating thereto. Overall, reactivity of IgG autoantibodies was stronger than that of IgA autoantibodies; however, IgA autoantibodies showed greater differential reactivity between cases and controls. Four IgA autoantibodies against SNRPB, PRPH, PTTG1 and SNAI1 were newly identified with sensitivities above 15% at 95% specificity, among which anti-SNRPB-IgA had the highest sensitivity of 24.0%. Autoantibodies associated with specific disease subtypes were also found.

Provided herein is a method for identifying patients at risk for suffering complications from pediatric Crohn's disease, and methods of treating those patients to prevent the development of penetrating complications.

The present invention relates to methods of diagnosing and predicting susceptibility to Crohn's Diseaese and/or IBD, by determining the presence or absence of susceptibility to genetic variants, risk haplotypes and/or protective haplotypes. In an embodiment, the invention provides methods of diagnosing and/or predicting susceptibility to Crohn's Disease in an individual by determining the presence or absence of risk variants at the IL12RB1, IL12RB2, IL17A, IL17RA, IL17RD and/or IL23R locus.

The invention provides for a method for identifying a biomarker in a fecal sample of a subject in need of such identification comprising: determining whether a fecal sample collected from a subject comprises a biomarker.

The invention relates to the diagnosis and treatment of diseases,including inflammatory disorders, proliferative disorders and autoimmune diseases. The invention provides, and involves the use of, antibody molecules that bind: i) lysozyme, ii) neutrophil elastase, iii) tissue inhibitor of metalloproteinase-1 (TIMP-1), or iv) the D domain of Tenascin-C. The invention also relates to the use of antibody molecules that bind v) the IIICS isoform of fibronectin, vi) the Extra Domain-B (ED-B) of fibronectin, vii) matrix-metalloproteinase 3 (MMP3), or viii) the A1 domain of tenascin-C in the diagnosis and treatment of inflammatory disorders such as inflammatory bowel disease.

The present invention describes methods for preventing IBS, reducing the likelihood of developing IBS and/or treating IBS by administering CDT inhibitors and/or CDT neutralizers to a subject in need thereof. The present invention also describes methods of eliciting a specific immune response and methods of vaccinating a subject to prevent IBS or to reduce the likelihood of developing or having IBS. The present invention further describes methods of diagnosing IBS by detecting the presence or absence of CDT or a CDT marker in a subject.

The present invention describes methods, assays, and systems of diagnosing, selecting and treating irritable bowel syndrome (IBS) based on a subject's level of anti-vinculin and anti-CdtB antibodies. IBS can be distinguished from inflammatory bowel (IBD) disease using the methods, assays, and systems described herein.

The present invention relates to a pharmaceutical composition comprising an Indigo Pulverata Levis extract or a fraction thereof as an effective ingredient for preventing or treating inflammatory bowel disease. Exhibiting the effect of reducing the activity and expression of inflammatory activation markers and alleviating the disease activity of inflammatory bowel disease, an Indigo Pulverata Levis extract or a fraction thereof according to the present invention is useful as an agent for preventing or treating inflammatory bowel disease.

The invention relates to the treatment of inflammatory bowel disease characterised by chronic inflammation. In particular, the invention relates to methods of predicting, treating or preventing post-operative recurrence of Crohn's disease.

The immunoglobulin single variable domains, compounds and constructs can be used for prophylactic, therapeutic or diagnostic purposes, such as for the treatment of inflammatory disease and/or disorder such as e.g. asthma, allergic asthma, chronic colitis, Crohn's disease, inflammatory bowel disease, and/or arthrosclerosis.