Compositions for management of disorders of the gastrointestinal tract
Inventors
GRABOWSKY, Mark • Playford, Raymond J. • Starzl, Timothy W. • MARCHBANK, Tania • Kelly, Paul • CHOUDHRY, Naheed
Assignees
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Publication Number
US-12263192-B2
Publication Date
2025-04-01
Expiration Date
Abstract
Effective and economical compositions and methods are disclosed for the treatment, and prevention of diseases and disorders associated with inflammation and/or damage to the gastrointestinal tract, including environmental enteric dysfunction. Compositions are provided comprising a synergistic combination of colostrum, immune egg, and optionally one or more additional active agents.
Core Innovation
The invention relates to an oral gastrointestinal composition that includes an egg antibody product comprising at least one specific avian antibody or an antigen binding fragment thereof and a bovine colostrum. The composition is administered to a subject in need thereof, and administration results in treatment of small intestinal bacterial overgrowth (SIBO).
The antibody component is described as specific for pathogenic organisms and/or pathogen-related components, including pathogens, toxins, adhesins, antigenic regions, and cross-reactive antigen clusters. The disclosure also describes the composition for gastrointestinal inflammatory conditions and infectious diarrhea, and for conditions linked to intestinal inflammation such as environmental enteric dysfunction (EED) and inflammatory bowel disease.
Embodiments further describe dried immune egg antibody product mixed with dried bovine colostrum, with optional inclusion of an additional active agent, and oral dose-controlled delivery using solid or liquid forms. The document also reports ELISA-based antibody titer characterization, improved gut repair, reduced bacterial translocation, improved epithelial integrity in Caco-2 epithelial barrier models, and biomarker-related outcomes including fecal Reg1B and fecal MPO, serum CRP and serum sCD14, urine lactulose:mannitol ratio, plasma and fecal cytokine measurements, and hydrogen breath testing.
Claims Coverage
The claim coverage centers on treating SIBO by administering a composition comprising an egg antibody product with at least one specific avian antibody or antigen binding fragment thereof and bovine colostrum. Across the provided items, five inventive features are repeatedly identified: antibody specificity, toxin target selection, biomarker decrease, and hydrogen breath testing threshold comparisons.
Treating small intestinal bacterial overgrowth with egg antibody product and bovine colostrum
Administering an effective amount of a composition comprising an egg antibody product comprising at least one specific avian antibody or antigen binding fragment thereof and a bovine colostrum, wherein the administration results in treatment of the SIBO.
Antibody specificity for pathogenic component count
The avian antibodies or antigen binding fragments are specific for a pathogenic component from one to eight different pathogenic organisms.
Selectable pathogen-related toxin targets
The pathogen-related toxin is selected from a defined group of named toxins and toxin combinations.
Biomarker decrease as treatment outcome
The treating decreases the expression of one or more selected biomarkers chosen from the specified list, and their combinations.
Hydrogen-breath SIBO threshold comparisons after lactulose and glucose challenges
Comparing subject breath SIBO levels where SIBO after lactulose is more than 20 ppm above a baseline or control, and the post-lactulose SIBO is more than 12 ppm greater than the SIBO level after a glucose challenge, compared to the baseline or control.
Overall, the claim coverage is centered on treating SIBO by administering an egg antibody product together with bovine colostrum, with dependent refinements specifying pathogen-target scope, named toxin target categories, biomarker-decrease outcomes, and hydrogen breath testing threshold criteria.
Stated Advantages
Treats small intestinal bacterial overgrowth (SIBO) in a subject in need thereof.
Decreases expression of selected biomarkers associated with treatment-related outcomes.
Provides measurable changes using hydrogen breath testing based on defined post-lactulose and post-glucose SIBO comparisons.
Improved intestinal barrier function, including reduced bacterial translocation and improved epithelial integrity in described models.
Documented Applications
Treating small intestinal bacterial overgrowth (SIBO) in a subject in need thereof.
Treatment of gastrointestinal inflammatory conditions and infectious diarrhea.
Management of inflammatory bowel disease conditions, including ulcerative colitis, Crohn’s disease, and indeterminate colitis.
Management of environmental enteric dysfunction (EED) and conditions linked to intestinal inflammation.
Supportive indication coverage for leaky gut, tropical sprue, severe acute malnutrition (SAM), NSAID/chemo/radiation mucositis, peptic ulcers, gastritis, pseudomembranous colitis, and necrotizing enterocolitis.
Biomarker and diagnostic application using fecal Reg1B/MPO, serum CRP/sCD14, urine lactulose:mannitol ratio, plasma cytokines, and hydrogen breath testing.
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