Methods and compositions for prevention and treatment of Clostridium difficile-associated diseases
OwnerDale N. Gerdinginventor
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Abstract
This invention provides methods and compositions for preventing and treating Clostridium difficile-associated disease in a subject, wherein the subject is either a human or non-human animal. The method comprises administering to the subject an effective amount of a non-toxigenic strain of C. difficile or a combination of strains. A suitable non-toxigenic strain is selected from the M, T, C, P, S and AP group as defined by restriction endonuclease analysis. Also provided are pharmaceutical compositions and unit dosage forms comprising a single strain or a combination of strains selected from a non-toxigenic C. difficile group and a method for selecting non-toxigenic C. difficile strains.
Claims36
A pharmaceutical composition comprising a pharmaceutically-acceptable carrier and at least one non-toxigenic strain of C. difficile, said strain not producing C. difficile toxins A and B and selected from the group consisting of M, M3, M23, T, T7, C, P, S, and AP as defined by restriction endonuclease analysis (REA) of the total genomic DNA of C. difficile isolates, on agarose gels.
A pharmaceutical composition comprising a pharmaceutically-acceptable carrier and a combination of at least two non-toxigenic strains of C. difficile and not producing C. difficile toxins A and B and selected from the group consisting of M, M3, M23, T, T7, C, P, S, and AP as defined by restriction endonuclease analysis (REA) of the total genomic DNA of C. difficile isolates, on agarose gels.
A unit dosage form of a pharmaceutical composition comprising a non-toxigenic strain of C. difficile in a pharmaceutically-acceptable carrier said strains not producing C. difficile toxins A and B and selected from the group consisting of M, M3, M23, T, T7, C, P, S, and AP as defined by restriction endonuclease analysis (REA) of the total genomic DNA of C. difficile isolates, on agarose gels.
A method for preventing disease caused by Clostridium difficile in a subject treated with at least one antibiotic said method comprising establishing colonization by non-toxigenic Clostridium difficile of a gastrointestinal tract of the subject, by:
- (a) obtaining at least one non-toxigenic strain of C. dfficile;
- said strain not producing toxins A or B and selected from the group consisting of M, M3, M23, T, T7, C, P, S and AP;
- and
- (b) administering to the subject within about 48 hours after the subject begins to receive antibiotics, an amount of at least one C. difficile strain sufficient to establish colonization within about 24-72 hours of administration of the non-toxigenic strain.
A method for preventing disease caused by Clostridium difficile in a subject treated with at least one antibiotic said method comprising establishing colonization by non-toxigenic Clostridium difficile of a gastrointestinal tract of the subject by:
- (a) obtaining two or more non-toxigenic strains of C. difficile wherein the strains are selected from the group consisting of M, M3, M23, T, T7, C, P, S, and AP as defined by restriction endonuclease analysis (REA) of the total genomic DNA of C. difficile isolates, on agarose gels;
- and
- (b) administering to the subject an amount of the two or more C. difficile strains sufficient to establish colonization within two days of antibiotic administration.
A method for treating a subject having a disease caused by toxigenic Clostridium difficile, said method comprising administering first an antibiotic followed within about 24 hours after antibiotics are stopped by a dose of at least one non-toxigenic strain of C. difficile, that is effective to reduce or suppress regrowth of the population of toxigenic C. difficile in the gastrointestinal tract of the subject and to control diarrhea in the subject said method comprising:
- (a) obtaining at least one non-toxigenic strain of C. difficile wherein the strain is selected from the group consisting of M, M3, M23, T, T7, C, P, S, and AP;
- and
- (b) administering to the subject an amount of the at least one non-toxigenic C. difficile strain sufficient to establish colonization within about 24-72 hours after administration of the non-toxigenic strain.
A method to prevent relapse of C. difficile disease caused by toxigenic C. difficile, said method comprising administering first an antibiotic followed by administering an effective dose of at least one non-toxigenic C. difficile strain within about 24 hours after the antibiotic, said strains not producing C. difficile toxins A and B and selected from the group consisting of M, M3, M23, T, T7, C, P, S, and AP.
Dependencies are inferred from the claim text.