Compositions and methods for the treatment of allergy
Inventors
Szabady, Rose L. • Olle, Bernat • Roberts, Bruce
Assignees
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Publication Number
US-11000556-B2
Publication Date
2021-05-11
Expiration Date
Abstract
Provided herein are compositions and methods for the treatment of allergy, such as food allergy. Also provided herein are compositions and methods for modulating an immune response associated with allergy and/or inducing immune tolerance or desensitization to an allergy, such as a food allergy.
Core Innovation
The invention relates to treating food allergy, including IgE-mediated food allergy, by orally administering to a subject in need thereof a therapeutically effective amount of a composition comprising a purified live bacterial mixture. The mixture includes seven bacterial strains, and each strain is included as a component of the therapeutic composition for immune response modulation.
In one aspect, each of the seven strains is defined by 16S rDNA sequences having at least 99.5% sequence identity to specified SEQ ID NOs. In another aspect, the seven strains are selected from a group consisting of Clostridium bolteae, Anaerotruncis colihominis, Eubacterium fissicatena, Clostridium symbiosum, Blautia producta, Dorea longicatena, Clostridium innocuum, and Flavinofractor plautii.
The described immune-modulatory outcomes include inducing regulatory T cells, reducing IgE responses, and reducing Th2 immune responses, including Foxp3+ CD4+ regulatory T cells and GATA3+ Tregs in the context of food allergy models. The disclosed approach also includes spore form or vegetative form and food products in which spore or vegetative forms are incorporated.
Claims Coverage
The independent claims cover two alternative ways of defining and administering a purified seven-strain bacterial mixture for oral treatment of food allergy, with 2 inventive features defined by 16S rDNA sequence identity or by selection from a specified set of bacterial species.
Seven-strain purified bacterial mixture defined by 16S rDNA sequence identity
Orally administering to a subject a therapeutically effective amount of a purified bacterial mixture comprising 7 bacterial strains, wherein there is 1 strain comprising each of the 16S rDNA sequences having at least 99.5% sequence identity to SEQ ID NO:1 through SEQ ID NO:8.
Seven-strain purified bacterial mixture selected from specified species
Orally administering to a subject a therapeutically effective amount of a purified bacterial mixture comprising 7 bacterial strains selected from the group consisting of Clostridium bolteae, Anaerotruncis colihominis, Eubacterium fissicatena, Clostridium symbiosum, Blautia producta, Dorea longicatena, Clostridium innocuum, and Flavinofractor plautii.
Across the independent claims, the inventive core is oral administration of a purified seven-strain bacterial mixture for treating food allergy, with strain selection defined either by 16S rDNA sequence identity to specified SEQ ID NOs or by selection from a specified set of bacterial species.
Stated Advantages
Induces regulatory T cells, including Foxp3+ CD4+ regulatory T cells and GATA3+ Tregs.
Suppresses IgE/Th2 inflammatory responses.
Provides protection in mouse models of food allergy.
Supports immune desensitization and immune tolerance in the food allergy context.
Documented Applications
Treating a food allergy, including IgE-mediated food allergy, by orally administering a therapeutically effective composition containing the purified bacterial mixture.
Use of bacterial compositions in food products, incorporating spore form and/or vegetative form.
Mouse-model assessment of food allergy, including induction of regulatory T cells and suppression of IgE/Th2 responses.
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