US2022080003A1PendingUtilityA1

Lactic acid bacterial strains

Assignee: 4D PHARMA RES LTDPriority: Jul 14, 2011Filed: Apr 16, 2021Published: Mar 17, 2022
Est. expiryJul 14, 2031(~5 yrs left)· nominal 20-yr term from priority
Inventors:Denise Kelly
C12N 1/205C12R 2001/225C12N 1/20A61P 1/12Y02A50/30A23K 10/18A61P 1/04A61P 1/00A23L 33/135A61P 29/00C12R 2001/25A61P 1/10C12R 2001/23A23V 2002/00A61P 31/04A61K 35/747A61P 1/14A61K 35/74
73
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Claims

Abstract

A first aspect of the invention relates to a porcine lactic acid bacterial strain, wherein said bacterial strain is characterised by one or more of the following characteristics: (i) the ability to exhibit antimicrobial activity against E. coli; (ii) the ability to exhibit antimicrobial activity against S. enteritidis; (iii) the ability to suppress inflammation in IPEC cells induced by 12-O-tetradecaboylphorbol-13-acetate (PMA); (iv) the ability to block the attachment or invasion of IPEC cells by S. enteritidis; (v) the ability to block the attachment or invasion of IPEC cells by E. coli; (vi) the absence of antibiotic resistance to one or more antibiotics selected from the following: ampicillin; cefotaxime; chloramphenicol; erythromycin; gentamicin; tetracycline; vancomycin; metronizadole; nalidixic acid; and kanamycin; and (vii) the ability to exhibit heat stability when subjected to three cycles of heating, each cycle comprising heating at a temperature of 70° C. for a period of 15 minutes. Further aspects of the invention relate to compositions comprising said bacterial strains, and therapeutic uses of said bacterial strains.

Claims

exact text as granted — not AI-modified
1 .- 31 . (canceled) 
     
     
         32 . A pharmaceutical composition comprising at least 10 3  colony forming units (CFU) of at least one  Lactobacillus  bacteria strain, and a pharmaceutically acceptable excipient, diluent, or carrier, wherein the at least one  Lactobacillus  bacteria strain comprises a 16S rRNA gene sequence with at least 95% sequence identity to a 16S rRNA gene sequence selected from the group consisting of SEQ ID NOs 10, 11, 13, and 14, as determined by a sequence alignment performed using BLAST, and wherein the pharmaceutical composition is a solid formulation. 
     
     
         33 . The pharmaceutical composition of  claim 32 , wherein the pharmaceutical composition is lyophilized. 
     
     
         34 . The pharmaceutical composition of  claim 32 , wherein the pharmaceutical composition is encapsulated in one or more capsules. 
     
     
         35 . The pharmaceutical composition of  claim 32 , wherein the pharmaceutical composition further comprises a preservative or stabilizer. 
     
     
         36 . The pharmaceutical composition of  claim 35 , wherein the preservative comprises sodium benzoate, sorbic acid, or esters of p-hydroxybenzoic acid. 
     
     
         37 . The pharmaceutical composition of  claim 32 , wherein the pharmaceutical composition comprises from about 10 3  to about 10 11  colony forming units (CFU) of the at least one  Lactobacillus  bacteria strain per gram of the pharmaceutical composition. 
     
     
         38 . The pharmaceutical composition of  claim 32 , wherein the at least one  Lactobacillus  bacteria strain exhibits at least one characteristic selected from the group consisting of:
 (i) antimicrobial activity against  E. coli;      (ii) antimicrobial activity against  S. enteritidis;      (iii) suppression of inflammation in intestinal pig epithelial cells (IPEC) induced by 12-O-tetradecaboylphorbol-13-acetate (PMA);   (iv) an ability to block the adherence or invasion of the IPEC by  S. enteritidis;      (v) an ability to block the adherence or invasion of the IPEC by  E. coli ; and   (vi) absence of antibiotic resistance to an antibiotic selected from the group consisting of ampicillin, cefotaxime, chloramphenicol, erythromycin, gentamicin, tetracycline, vancomycin, metronizadole, nalidixic acid, and kanamycin.   
     
     
         39 . The pharmaceutical composition of  claim 38 , wherein the at least one  Lactobacillus  bacteria strain exhibits at least two characteristics selected from the group of  claim 38 . 
     
     
         40 . The pharmaceutical composition of  claim 38 , wherein the at least one  Lactobacillus  bacteria strain exhibits at least three characteristics selected from the group of  claim 38 . 
     
     
         41 . The pharmaceutical composition of  claim 32 , wherein the at least one  Lactobacillus  bacteria strain is of a species selected from the group consisting of  Lactobacillus johnsonii, Lactobacillus reuteri, Lactobacillus plantarum, Lactobacillus paraplantarum, Lactobacillus gasseri, Lactobacillus pentosus, Lactobacillus helveticus, Lactobacillus acidophilus, Lactobacillus vaginalis, Lactobacillus  mucosae, and any combinations thereof. 
     
     
         42 . A method of treating an intestinal disorder in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising at least at least 10 3  colony forming units (CFU) of at least one  Lactobacillus  bacteria strain, and a pharmaceutically acceptable excipient, diluent, or carrier, wherein the at least one  Lactobacillus  bacteria strain comprises a 16S rRNA gene sequence with at least 93% sequence identity to a 16S rRNA gene sequence selected from the group consisting of SEQ ID NOs 10, 11, 13, and 14, as determined by sequence alignment performed using BLAST, and wherein the pharmaceutical composition is a solid formulation in unit dose form. 
     
     
         43 . The method of  claim 42 , wherein the intestinal disorder is selected from the group consisting of  salmonellosis , irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), functional dyspepsia, functional constipation, functional diarrhea, functional abdominal pain, functional bloating, Epigastric Pain Syndrome, Postprandial Distress Syndrome, Crohn's disease, ulcerative colitis, gastroesophageal reflux disease (GERD), necrotizing enterocolitis, and any combination thereof. 
     
     
         44 . The method of  claim 42 , wherein the administering is oral. 
     
     
         45 . The method of  claim 42 , wherein the subject is a human. 
     
     
         46 . The method of  claim 42 , wherein the at least one  Lactobacillus  bacteria strain is of a species selected from the group consisting of  Lactobacillus johnsonii, Lactobacillus reuteri, Lactobacillus plantarum, Lactobacillus paraplantarum, Lactobacillus gasseri, Lactobacillus pentosus, Lactobacillus helveticus, Lactobacillus acidophilus, Lactobacillus vaginalis, Lactobacillus  mucosae, and any combinations thereof. 
     
     
         47 . A method of improving intestinal microbiota in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising at least at least 10 3  colony forming units (CFU) of at least one  Lactobacillus  bacteria strain, and a pharmaceutically acceptable excipient, diluent, or carrier, wherein the at least one  Lactobacillus  bacteria strain comprises a 16S rRNA gene sequence with at least 95% sequence identity to a 16S rRNA gene sequence selected from the group consisting of SEQ ID NOs 10, 11, 13, and 14, as determined by sequence alignment performed using BLAST, and wherein the pharmaceutical composition is a solid formulation. 
     
     
         48 . A method of improving growth in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising at least at least 10 3  colony forming units (CFU) of at least one  Lactobacillus  bacteria strain, and a pharmaceutically acceptable excipient, diluent, or carrier, wherein the at least one  Lactobacillus  bacteria strain comprises a 16S rRNA gene sequence with at least 95% sequence identity to a 16S rRNA gene sequence selected from the group consisting of SEQ ID NO 41, as determined by sequence alignment performed using BLAST, and wherein the pharmaceutical composition is a solid formulation. 
     
     
         49 . The method of  claim 48 , wherein the subject comprises an early-weaned animal. 
     
     
         50 . The method of  claim 48 , wherein the subject comprises a sheep, a goat, a cow, a pig, a horse, a cat, a dog, a turkey, a duck, a chicken, a fish, or a crustacean. 
     
     
         51 . The method of  claim 48 , wherein the improving growth comprises gaining weight.

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