KR-102962513-B1 - A mixture of probiotic bacterial strains for use in treating allergic asthma with recurrent wheezing, preferably in pediatric patients.

Abstract

The present invention relates to a bacterial isolate of the species Bifidobacterium breve (B632) belonging to DSM 24706 for use in the treatment of respiratory airway disorders or diseases or conditions and in the treatment of asthma and dyspnea. Furthermore, the present invention relates to a mixture comprising or alternatively composed of the bacterial isolate for use in the treatment of respiratory airway disorders or diseases or conditions and in the treatment of asthma and dyspnea. Furthermore, the present invention relates to a composition for use in the treatment of respiratory airway disorders or diseases or conditions; and in the treatment of asthma and dyspnea, comprising the above-mentioned mixture and, optionally, one or more physiologically and/or pharmacologically acceptable additives and/or technical excipients. Such isolates, mixtures, and compositions are effectively administered and are used to treat pediatric patients.

Inventors

• 모그나 베라
• 파네 마르코
• 아모루소 안젤라

Assignees

• 프로바이오티컬 에스.피.에이.

Dates

Publication Date

20260507

Application Date

20200306

Priority Date

20190307

Claims (13)

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2. delete
3. a) A bacterial isolate of the species Lactobacillus salivarius, deposited as Lactobacillus salivarius (LS01) under accession number DSM 22775 to Deutsche Sammlung von Mikrooriganismen und Zellkulturen GmbH (DSMZ) on July 23, 2009, b) a bacterial isolate belonging to the species Bifidobacterium breve, deposited as Bifidobacterium breve (B632) under accession number DSM 24706 with Deutsche Sammlung von Mikrooriganismen und Zellkulturen GmbH (DSMZ) on April 7, 2011, and Optionally, one or more physiologically and/or pharmacologically acceptable additives or excipients including, A pharmaceutical composition for use in the treatment of asthma, recurrent wheezing, allergic rhinitis, respiratory difficulty, or dyspnea in an individual.
4. In paragraph 3, A composition in which the above-mentioned individual is a child individual.
5. In paragraph 3, The above bacterial isolates a) and b) are compositions in which [Lactobacillus salivarius (LS01) DSM 22775 : Bifidobacterium breve (B632) DSM 24706] are present in a weight ratio of 1:4 to 4:1; 1:3 to 3:1; 1:2 to 2:1; or 1:1.
6. In paragraph 3, A composition in which the total concentration of bacterial isolates a) and b) present in the above composition is 1x10⁶ CFU/g (or AFU/g) to 1x10¹² CFU/g (or AFU/g); or 1x10⁸ CFU/g (or AFU/g) to 1x10¹⁰ CFU/g (or AFU/g); or 1x10⁹ CFU/g (or AFU/g).
7. In paragraph 3, The above bacterial isolates a) and b) exist as living bacterial cell cultures, and the cells are whole and/or viable cells; or A composition in which the above bacterial isolates a) and b) are present as a bacterial culture of non-viable cells, or as a cell component, or as a cell extract, or as a cell lysate.
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9. In paragraph 3, A composition in which the above excipient is selected from maltodextrin and inulin.
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11. In paragraph 3, A composition intended for use in treating pediatric asthma.
12. A method for manufacturing a composition according to any one of paragraphs 3 through 7, 9 and 11, The following bacterial isolates deposited with Deutsche Sammlung von Mikrooriganismen und Zellkulturen GmbH (DSMZ): a) Lactobacillus salivarius (LS01) DSM 22775, deposited on July 23, 2009; and b) Bifidobacterium breve (B632) DSM 24706 deposited on April 7, 2011 The step of mixing, and Optionally, A step of obtaining the composition by mixing with one or more physiologically and/or pharmacologically acceptable additives or excipients. A manufacturing method comprising
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Description

A mixture of probiotic bacterial strains for use in treating allergic asthma with recurrent wheezing, preferably in pediatric patients. The present invention relates to a bacterial isolate belonging to the species Bifidobacterium breve (B632) DSM 24706 for use in treating disorders (disorders) or diseases (disorders) or conditions associated with deformation of the respiratory airway, and for use in treating asthma and dyspnea. The present invention also relates to a mixture comprising, or alternatively composed of, a probiotic bacterial isolate for use in treating disorders, diseases, or conditions associated with deformation of the respiratory airway; or for use in treating asthma and dyspnea. Furthermore, the present invention relates to a composition comprising the said mixture and optionally one or more physiologically and/or pharmacologically acceptable additives and/or technical excipients for use in treating disorders, diseases, or conditions of the respiratory airway, and for use in treating asthma and dyspnea. Such isolates, mixtures, and compositions are appropriately administered and used to treat pediatric patients. Asthma (GINA 2016 [1]; World Asthma Organization) is a heterogeneous disease characterized by chronic airway obstruction. Asthma is defined by respiratory symptoms such as dyspnea or wheezing, shortness of breath, chest tightness, and coughing, varying in intensity and duration, along with airway flow limitation; asthma can be triggered by various stimuli, including allergens, exposure to irritants, viruses, and physical exercise. Currently, these symptoms can be relieved by bronchodilators or anti-inflammatory agents (e.g., glucocorticoid drugs). Asthma recognizes various population "clusters" with heterogeneous clinical and physiological-pathological features referred to as "asthma phenotypes." The two most representative asthma phenotypes are as follows: - Allergic asthma: A better-known and easily identifiable asthma phenotype characterized by eosinophilic inflammation and a response to inhaled corticosteroids; - Non-allergic asthma: An asthma phenotype characterized by neutrophilic or eosinophilic inflammation, or the presence of minor inflammatory cells, distinguished by a poor response to inhaled cortisone therapy. Particularly in preschool-aged children, viral infections are significantly important as triggers for bronchospasm attacks. In recent years, the gut microbiome has become very important for the development of allergic and autoimmune diseases [2, 3]. An inadequate gut microbiome can be the basis for immunological phenomena that induce an increase in disease-triggering pro-inflammatory cells (cells that produce interleukin and cytokines in allergic inflammation). Restoring an appropriate gut microbiome can reduce or even delay the onset and exacerbation of allergic and autoimmune diseases. This is disclosed, for example, in the document US 9498503. In this document, selected probiotic strains are used to treat allergic diseases, particularly atopic dermatitis. Specifically, this document relates to treatments to reduce and/or heal skin inflammation and/or reduce symptoms such as redness, itching, and eczema of the skin tissue. Such treatments utilize Lactobacillus salivarius (LS01) and Bifidobacterium breve. It involves the administration of bacterial strains such as breve (BR03) and Lactobacillus pentosus (LPS01). In this study, these strains are identified as potentially effective in treating inflammatory skin diseases. However, the studies published in this literature are not intended to treat and/or alleviate asthma symptoms and dyspnea, and such claims are not presumed or emphasized. The use of bacterial strains Lactobacillus salivarius (LS01) and Bifidobacterium breve (BR03) for treating skin diseases has also been disclosed from the study by E. Nettis et al., Vol 48, N5, 182-187, 2016. This literature describes the use of the probiotic strains Lactobacillus salivarius LS01 and Bifidobacterium breve BR03 in treating spontaneous chronic urticaria (see "Description of Invention"). Specifically, this study involved a group of adult patients suffering from spontaneous chronic urticaria and showed that at least partial remission was achieved upon administration of the aforementioned bacterial strains. The authors argued that the evidence suggests that probiotic bacteria can modulate the skin's immune system. According to this literature, among the patients who responded positively to the treatment of chronic urticaria, some also suffered from allergic rhinitis. However, the treatment of allergic rhinitis is not addressed in any way, nor is it intended to treat its symptoms. Furthermore, there is no mention of the treatment of respiratory disorders or diseases potentially associated with allergic rhinitis. In light of the foregoing, it is evident that there has been little mention of the ability of probiotics to directly intervene in reducing and/or resolving the sym