Pharmaceutical preparation comprising a combination of streptococcus strains and lactobacillus strains

Abstract

A pharmaceutical preparation for prophylaxis against and treatment of Staphylococcus induced infections or conditions in humans and animals, is disclosed, wherein it comprises a combination of a) one or more viable α- Streptococcus strains chosen from the group consisting of the Streptococcus sanguis II strains having the accession numbers NCIMB 40104, NCIMB 40105, NCIMB 40106, and NCIMB 40873, the Streptococcus mitis strains having the accession numbers NCIMB 40107, and NCIMB 40874, the Streptococcus oralis strains having the accession numbers NCIMB 40875 and NCIMB 40876, the Streptococcus lactis strain L1A having the accession number NCIMB 40157, and one or more variants thereof having the same or essentially similar effect; and b) one or more viable Lactobacillus strains chosen from the group consisting of the Lactobacillus rhamnosus strain LB21 having the accession number NCIMB 40564, the Lactobacillus plantarum strain LB3 having the accession number DSM 17852, and the Lactobacillus plantarum strain LB7 having the accession number DSM 17853, and one or more variants thereof having the same or essentially similar effect; in at least one pharmaceutically acceptable medium in which said strains maintain their viability, as well as a kit for and a method of prophylaxis and treatment of Staphylococcus induced infections and conditions, and use

1 . A pharmaceutical preparation for treatment of  Staphylococcus  induced infections or conditions in humans and animals, comprising a combination of:
 a) one or more viable α-Streptococcus strains chosen from the group consisting of  Streptococcus sanguis  II strains having the accession numbers NCIMB 40104, NCIMB 40105, NCIMB 40106, and NCIMB 40873,  Streptococcus mitis  strains having the accession numbers NCIMB 40107, and NCIMB 40874,  Streptococcus oralis  strains having the accession numbers NCIMB 40875 and NCIMB 40876, and  Streptococcus lactis  strain L1A having the accession number NCIMB 40157; and   b) one or more viable  Lactobacillus  strains chosen from the group consisting of  Lactobacillus rhamnosus  strain LB21 having the accession number NCIMB 40564,  Lactobacillus plantarum  strain LB3 having the accession number DSM 17852,  Lactobacillus plantarum  strain LB7 having the accession number DSM 17853,  Lactobacillus plantarum  strain LB931 having the accession number DSM 11918, and  Lactobacillus fermentum  strain LB Ess-1, having the accession number DSM 17851;   wherein the combination further comprises at least one pharmaceutically acceptable medium.   
     
     
         2 . The pharmaceutical preparation according to  claim 1 , wherein the combination comprises the  Streptococcus sanguis  strains having the accession numbers NCIMB 40104 and NCIMB 40106, and the  Streptococcus oralis  strain having the accession number NCIMB 40876, and the  Lactobacillus rhamnosus  strain LB21 having the accession number NCIMB 40564. 
     
     
         3 . The pharmaceutical preparation according to  claim 2 , wherein the combination comprises the  Streptococcus sanguis  II strain having the accession number NCIMB 40104 and the  Lactobacillus rhamnosus  strain LB21 having the accession number NCIMB 40564. 
     
     
         4 . (canceled) 
     
     
         5 . The pharmaceutical preparation according to  claim 1 , wherein the combination is an oral, oromucosal, gingival, nasal, dental, cutaneous/skin, vaginal, rectal or ear formulation. 
     
     
         6 . The pharmaceutical preparation according to  claim 5 , wherein the combination is a powder, a granule, a cachet, a capsule, a tablet, a paste, a cream, a gel, an ointment, a salve, a foam, a paste, a lotion, a cream, an oil suspension, a spray, a suspension, a solution, an emulsion, a patch, a stick, a spray, a nasal spray, or a buccal spray, a mouth wash, or a drink or solution. 
     
     
         7 . The pharmaceutical preparation according to  claim 1 , wherein the pharmaceutically acceptable medium is a soured, fermented milk product or combinations thereof. 
     
     
         8 . The pharmaceutical preparation according to  claim 1 , wherein the pharmaceutically acceptable medium is an animal feed stuff, whey, dry fodder, a concentrated suspension, or combinations thereof. 
     
     
         9 . The pharmaceutical preparation according to  claim 1 , wherein the combination comprises lyophilised α- Streptococcus  strains and lyophilised  Lactobacillus  strains. 
     
     
         10 . The pharmaceutical preparation according to  claim 9 , wherein the combination is present in a NaCl solution, a glucose solution, or skim milk. 
     
     
         11 . A kit for treatment of  Staphylococcus  induced infections and conditions, wherein the kit comprises two or more separate formulations to be administered at the same time, to a human or an animal in need thereof,
 wherein the two or more separate formulations comprises a combination of strains including:   a) one or more viable α-Streptococcus strains chosen from the group consisting of  Streptococcus sanguis  II strains having the accession numbers NCIMB 40104, NCIMB 40105, NCIMB 40106, and NCIMB 40873,  Streptococcus mitis  strains having the accession numbers NCIMB 40107, and NCIMB 40874,  Streptococcus oralis  strains having the accession numbers NCIMB 40875 and NCIMB 40876, and  Streptococcus  lactis strain L1A having the accession number NCIMB 40157; and   b) one or more viable  Lactobacillus  strains chosen from the group consisting of  Lactobacillus rhamnosus  strain LB21 having the accession number NCIMB 40564,  Lactobacillus plantarum  strain LB3 having the accession number DSM 17852,  Lactobacillus plantarum  strain LB7 having the accession number DSM 17853,  Lactobacillus plantarum  strain LB931 having the accession number DSM 11918, and  Lactobacillus fermentum  strain LB Ess-1, having the accession number DSM 17851;   wherein each formulation of the kit comprises at least one strain of the α-Streptococcus strains, the  Lactobacillus  strains, or a combination thereof.   
     
     
         12 . A method for treatment of a  Staphylococcus  induced infection or condition, according to  claim 1 , comprising administering the combination to a human or animal that is a methicillin-resistant  Staphylococcus aureus  carrier. 
     
     
         13 . The method according to  claim 12 , further comprising inducing the  Staphylococcus  induced infection or condition is induced by  Staphylococcus aureus, Staphylococcus epidermidis Staphylococcus saprophyticus  strains, or multi-resistant  Staphylococcus aureus  (MRSA) strains. 
     
     
         14 . The method according to  claim 13 , wherein the  Staphylococcus  induced infection or condition is present in the oral cavity, in the ear, in the nasal, and/or pharyngeal region, in the gastro-intestinal tract, on the skin, or other sites or organs within the body. 
     
     
         15 . The method according to  claim 12 , further comprising treating minor skin infections, pimples, impetigo, boils, cellulitis folliculitis, furuncles, carbuncles, scalded skin syndrome, and abscesses, as well as life-threatening diseases, preferably pneumonia, meningitis, osteomyelitis, endocarditis, toxic shock syndrome (TSS), septicaemia, or a combinations thereof. 
     
     
         16 . (canceled) 
     
     
         17 . The pharmaceutical preparation according to  claim 1 , wherein the combination comprises 10 4 -10 11  colony-forming units per ml of a ready-to-use preparation of one or more of the  Streptococcus  strains. 
     
     
         18 . The pharmaceutical preparation according to  claim 17 , wherein the combination comprises 10 6 -10 9  colony-forming units per ml of a ready-to-use preparation of one or more of the  Streptococcus  strains. 
     
     
         19 . The pharmaceutical preparation according to  claim 1 , wherein the combination comprises 10 4 -10 11  colony-forming units per ml of a ready-to-use preparation of one or more of the  Lactobacillus  strains. 
     
     
         20 . The pharmaceutical preparation according to  claim 19 , wherein the combination comprises 10 6 -10 9  colony-forming units per ml of a ready-to-use preparation of one or more of the  Lactobacillus  strains. 
     
     
         21 . The pharmaceutical preparation according to  claim 7 , wherein the pharmaceutically acceptable medium is sour milk, yoghurt and milk, fruit juice, ice-cream, soup, fruit drink, or combinations thereof. 
     
     
         22 . A kit for prophylaxis against and treatment of  Staphylococcus  induced infections and conditions, wherein the kit comprises two or more separate formulations to be administered at the same time in sequence within a predetermined time period, to a human or an animal in need thereof,
 wherein the two or more separate formulations comprises a combination of strains including:   a) one or more viable α-Streptococcus strains chosen from the group consisting of  Streptococcus sanguis  II strains having the accession numbers NCIMB 40104, NCIMB 40105, NCIMB 40106, and NCIMB 40873,  Streptococcus mitis  strains having the accession numbers NCIMB 40107, and NCIMB 40874,  Streptococcus oralis  strains having the accession numbers NCIMB 40875 and NCIMB 40876, and  Streptococcus lactis  strain L1A having the accession number NCIMB 40157; and   b) one or more viable  Lactobacillus  strains chosen from the group consisting of  Lactobacillus rhamnosus  strain LB21 having the accession number NCIMB 40564,  Lactobacillus plantarum  strain LB3 having the accession number DSM 17852,  Lactobacillus plantarum  strain LB7 having the accession number DSM 17853,  Lactobacillus plantarum  strain LB931 having the accession number DSM 11918, and  Lactobacillus fermentum  strain LB Ess-1, having the accession number DSM 17851;   wherein each formulation of the kit comprises at least one strain of the α-Streptococcus strains, the  Lactobacillus  strains, or a combination thereof.   
     
     
         23 . A kit according to  claim 22 , wherein the predetermined time period is within 24 hours. 
     
     
         24 . A kit according to  claim 11 , wherein the two or more separate formulations is administered to a human or animal that is a methicillin-resistant  S. aureus  carrier.