Lactic acid bacterial composition for the treatment of bacterial vaginal infections by gardnerella vaginalis and, if present, of concurrent fungal infections

Abstract

The present invention relates to a pharmaceutical composition or a composition for a medical device or a composition for a food supplement (briefly, the composition (s) of the present invention) based on lactic acid bacteria belonging to the species Lactobacillus fermentum for vaginal and oral use for the simultaneous treatment of vaginal infections, disorders or diseases of fungal and bacterial origin. Specifically, the present invention relates to a said composition comprising pharmaceutical- and/or food-grade excipients and a mixture, which comprises or, alternatively, consists of at least a strain of bacteria belonging to the species Lactobacillus fermentum for vaginal and oral use for the simultaneous treatment of vaginal infections, disorders or diseases selected from candidiasis, vaginitis, vulvovaginitis or bacterial vaginosis.

1 . Pharmaceutical composition or composition for a medical device or composition for a food supplement or composition of a food product comprising pharmaceutical- and/or food-grade excipients and a mixture comprising or, alternatively, consisting of at least a strain of bacteria belonging to the species  Lactobacillus fermentum ; said composition being for vaginal or oral use for the treatment of at least a vaginal infection, wherein said at least a vaginal infection comprises or consists of bacterial vaginosis, caused by the pathogenic bacterium  Gardnerella vaginalis , wherein the bacteria of the species  Lactobacillus fermentum  belong to the strain (LF05) with deposit number DSM 32277 or CNCM I-789 (depositor Probiotical SpA). 
     
     
         2 . The composition for use according to  claim 1 , wherein said mixture further comprises or, alternatively, consists of at least a strain of bacteria belonging to the species  Lactobacillus fermentum  selected from the group comprising or, alternatively, consisting of the strains of bacteria from 3 to 14 below: 
       
         
           
                 
                 
                 
                 
                 
               
                     
                 
                   List of tested strain 
                   Abbreviation 
                   ID 
                   Deposit 
                   Depositor 
                 
                     
                 
                     
                 
                 
                 
                 
                 
                 
               
                   No. 3  L. fermentum   
                   LF 06 
                   1456 
                   DSM 18295 
                   Anidral Srl 
                 
                   No. 4  L. fermentum   
                   LF 07 
                   1459 
                   DSM 18296 
                   Anidral Srl 
                 
                   No. 5  L. fermentum   
                   LF 08 
                   1460 
                   DSM 18297 
                   Anidral Srl 
                 
                   No. 6  L. fermentum   
                   LF 09 
                   1462 
                   DSM 18298 
                   Anidral Srl 
                 
                   No. 7  L. fermentum   
                   LF 10 
                   1637 
                   DSM 19187 
                   Anidral Srl 
                 
                   No. 8  L. fermentum   
                   LF 11 
                   1639 
                   DSM 19188 
                   Anidral Srl 
                 
                   No. 9  L. fermentum   
                   DPPMA 114 
                   1757 
                   DSMZ 23757 
                   Probiotical SpA 
                 
                   No. 10  L. fermentum   
                   Lb2 
                   1753 
                   DSM 16143 
                   Probiotical SpA 
                 
                   No. 11  L. fermentum   
                   LF 15 
                   1852 
                   DSM 26955 
                   Probiotical SpA 
                 
                   No. 12  L. fermentum   
                   LF16 
                   1853 
                   DSM 26956 
                   Probiotical SpA 
                 
                   No. 13  L. fermentum   
                   LF18 
                   1897 
                   DSM 29197 
                   Probiotical SpA 
                 
                   No. 14  L. fermentum   
                   LF 25 
                   1956 
                   DSM 32275 
                   Probiotical SpA 
                 
                     
                 
             
                
                
                
               
               
                
               
            
             
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
         3 . The composition for use according to  claim 2 , wherein said mixture comprising or, alternatively, consisting of at least a strain of bacteria belonging to the species  Lactobacillus fermentum  selected from the group comprising or, alternatively, consisting of the strains of bacteria No. 7, 8, 11, 12, 13 and 14. 
     
     
         4 . The composition for use according to  claim 3 , wherein said mixture comprising or, alternatively, consisting of at least a strain of bacteria belonging to the species  Lactobacillus fermentum  selected from the group comprising or, alternatively, consisting of the strains of bacteria No. 8, 11, 13 and 14. 
     
     
         5 . The composition for use according to  claim 1 , wherein said vaginal infection further comprises a vaginal infection, vaginitis, vulvovaginitis o bacterial vaginosis due to at least a pathogen selected from the group comprising:  Candida albicans, Candida glabrata, Candida parapsilosis, Candida krusei, Candida tropicalis, Trichomonas vaginalis, Neisseria gonorrhoeae, Escherichia coli , Herpes simplex and  Hemophilus ducreyi.    
     
     
         6 . The composition for use according to  claim 1 , wherein said composition is for the treatment of a vaginal infection, disorder or disease caused by the pathogens  Candida albicans  and  Gardnerella vaginalis.    
     
     
         7 . The composition for use according to  claim 1 , wherein said composition is in a solid form or liquid form, preferably is in the form of powder, granules, tablet, lozenge, solution, vaginal douche, dispersion or gel. 
     
     
         8 . The composition for use according to  claim 1 , wherein said mixture contains said strains of bacteria at a concentration comprised from 1×10 8  to 1×10 12  CFU/g, preferably from 1×10 9  to 1×10 11  CFU/g. 
     
     
         9 . The composition for use according to  claim 1 , wherein said composition contains said strains of bacteria at a concentration comprised from 1×10 6  to 1×10 10  CFU/g, preferably from 1×10 7  to 1×10 9  CFU/g. 
     
     
         10 . The composition for use according to  claim 1 , wherein said mixture of bacteria in present in said composition in a weight ratio comprised from 1:2 to 1:10, preferably in a weight ratio comprised from 1:3 to 1:5.