Compositions and Methods for Microbe Storage and Delivery

Abstract

The present invention relates to the field of bacteriology. In particular, the invention relates to compositions of probiotic microbes and methods for making and using such compositions, e.g. in the treatment and prevention of catheter associated urinary tract infections.

1 . A composition comprising a probiotic microbe, a pharmaceutically acceptable gelling agent, and a pharmaceutically acceptable first protective agent, in freeze-dried form. 
   
   
       2 . The composition of  claim 1 , further comprising a pharmaceutically acceptable second protective agent. 
   
   
       3 . The composition of  claim 1 , where in said probiotic microbe is a strain of  E. coli.    
   
   
       4 . The composition of  claim 2 , wherein said strain of  E. coli  is  E. coli  83972. 
   
   
       5 . The composition of  claim 2 , wherein said strain of  E. coli  is  E. coli  HU2117. 
   
   
       6 . The composition of  claim 1 , wherein said gelling agent is selected from the group consisting of hydroxyethyl cellulose, hydroxymethyl cellulose, hydroxypropyl guar, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, carbomer, alginate, gelatin, and poloxamer. 
   
   
       7 . The composition of  claim 1 , where in said first protective agent is selected from the group consisting of non-fat milk solids, trehalose, glycerol, betaine, sucrose, glucose, lactose, dextran, polyethylene glycol, sorbitol, mannitol, poly vinyl propylene, potassium glutamate, monosodium glutamate, Tween 20 detergent, Tween 80 detergent, and an amino acid hydrochloride. 
   
   
       8 . The composition of  claim 2 , where in said second protective agent different from said first protective agent, and is selected from the group consisting of non-fat milk solids, trehalose, glycerol, betaine, sucrose, glucose, lactose, dextran, polyethylene glycol, sorbitol, mannitol, poly vinyl propylene, potassium glutamate, monosodium glutamate, Tween 20 detergent, Tween 80 detergent, and an amino acid hydrochloride. 
   
   
       9 . A composition produced by a method comprising:
 a) providing in an aqueous fluid a mixture comprising:
 i) a probiotic microbe; 
 ii) a pharmaceutically acceptable gelling agent; and 
 iii) a pharmaceutically acceptable first protective agent, 
   b) freeze-drying said mixture to produce a dried preparation; and   c) exposing said dried preparation to an aqueous fluid to form a gel, said gel comprising an effective amount of said probiotic microbe.   
   
   
       10 . The composition of  claim 9 , wherein said mixture further comprises a pharmaceutically acceptable second protective agent. 
   
   
       11 . The composition of  claim 9 , where in said probiotic microbe is a strain of  E. coli.    
   
   
       12 . The composition of  claim 11 , wherein said strain of  E. coli  is  E. coli  83972 
   
   
       13 . The composition of  claim 11 , wherein said strain of  E. coli  is  E. coli  HU2117. 
   
   
       14 . The composition of  claim 9 , wherein said gelling agent is selected from the group consisting of hydroxyethyl cellulose, hydroxymethyl cellulose, hydroxypropyl guar, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, carbomer, alginate, gelatin, and poloxamer. 
   
   
       15 . The composition of  claim 9 , where in said first protective agent is selected from the group consisting of non-fat milk solids, trehalose, glycerol, betaine, sucrose, glucose, lactose, dextran, polyethylene glycol, sorbitol, mannitol, poly vinyl propylene, potassium glutamate, monosodium glutamate, Tween 20 detergent, Tween 80 detergent, and amino acid hydrochloride. 
   
   
       16 . The composition of  claim 10 , where in said second protective agent different from said first protective agent, and is selected from the group consisting of non-fat milk solids, trehalose, glycerol, betaine, sucrose, glucose, lactose, dextran, polyethylene glycol, sorbitol, mannitol, poly vinyl propylene, potassium glutamate, monosodium glutamate, Tween 20 detergent, Tween 80 detergent, and an amino acid hydrochloride. 
   
   
       17 . A method of administering a probiotic microbe to a subject, comprising:
 a) providing a freeze-dried preparation comprising a probiotic microbe, a pharmaceutically acceptable gelling agent, and a pharmaceutically acceptable protective agent;   b) exposing said freeze dried preparation to an aqueous fluid to form a gel comprising an effective amount of said probiotic microbe; and   c) contacting said subject with said gel.   
   
   
       18 . The method of  claim 17 , wherein contacting said subject with said gel comprises contacting a medical device with said gel to produce a treated device, and contacting said subject with said treated device. 
   
   
       19 . The method of  claim 18 , wherein said medical device is a urinary catheter. 
   
   
       20 . The method of  claim 17 , wherein said probiotic microbe is  E. coli  HU2117 or  E. coli  83972. 
   
   
       21 . A kit comprising a composition comprising a probiotic microbe, a pharmaceutically acceptable gelling agent, and a pharmaceutically acceptable first protective agent, in freeze-dried form. 
   
   
       22 . The kit of  claim 21 , wherein said composition further comprises a pharmaceutically acceptable second protective agent. 
   
   
       23 . The kit of  claim 21 , further comprising a container of sterile aqueous fluid. 
   
   
       24 . The kit of  claim 21 , wherein said probiotic microbe is a strain of  E. coli.    
   
   
       25 . The kit of  claim 24 , wherein said strain of  E. coli  is  E. coli  83972. 
   
   
       26 . The kit of  claim 24 , wherein said strain of  E. coli  is  E. coli  HU2117.