Compositions and methods
First Claim
1. A method of treating or reducing a severity of at least one symptom of a gastrointestinal disease associated with a dysbiosis, comprising administering to a human subject a composition comprising a purified population of spore-forming bacteria consisting essentially of a population of germinable bacterial spores in an amount effective to populate a gastrointestinal tract in the subject and augment growth of at least one type of bacteria not detectably present in the composition or in the gastrointestinal tract prior to administration to the subject,wherein the composition comprises at least 1×
- 104 colony forming units of germinable bacterial spores per dose of the composition, and wherein the germinable bacterial spores comprise at least two bacterial entities comprising 16S rRNA sequences at least 97% identical to the nucleic acid sequences selected from the group consisting of SEQ ID NO. 673, SEQ ID NO. 674, SEQ ID NO. 774, SEQ ID NO. 845, SEQ ID NO. 847, SEQ ID NO. 848, SEQ ID NO. 856, and SEQ ID NO. 1670,thereby providing an amount effective to treat the gastrointestinal disease or reduce a severity of at least one symptom of the gastrointestinal disease in the subject.
3 Assignments
0 Petitions
Accused Products
Abstract
Disclosed herein are therapeutic compositions containing non-pathogenic, germination-competent bacterial spores, for the prevention, control, and treatment of gastrointestinal diseases, disorders and conditions and for general nutritional health.
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Citations
24 Claims
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1. A method of treating or reducing a severity of at least one symptom of a gastrointestinal disease associated with a dysbiosis, comprising administering to a human subject a composition comprising a purified population of spore-forming bacteria consisting essentially of a population of germinable bacterial spores in an amount effective to populate a gastrointestinal tract in the subject and augment growth of at least one type of bacteria not detectably present in the composition or in the gastrointestinal tract prior to administration to the subject,
wherein the composition comprises at least 1× - 104 colony forming units of germinable bacterial spores per dose of the composition, and wherein the germinable bacterial spores comprise at least two bacterial entities comprising 16S rRNA sequences at least 97% identical to the nucleic acid sequences selected from the group consisting of SEQ ID NO. 673, SEQ ID NO. 674, SEQ ID NO. 774, SEQ ID NO. 845, SEQ ID NO. 847, SEQ ID NO. 848, SEQ ID NO. 856, and SEQ ID NO. 1670,
thereby providing an amount effective to treat the gastrointestinal disease or reduce a severity of at least one symptom of the gastrointestinal disease in the subject. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 17, 18, 19, 20, 21)
- 104 colony forming units of germinable bacterial spores per dose of the composition, and wherein the germinable bacterial spores comprise at least two bacterial entities comprising 16S rRNA sequences at least 97% identical to the nucleic acid sequences selected from the group consisting of SEQ ID NO. 673, SEQ ID NO. 674, SEQ ID NO. 774, SEQ ID NO. 845, SEQ ID NO. 847, SEQ ID NO. 848, SEQ ID NO. 856, and SEQ ID NO. 1670,
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10. A method of treating or preventing a dysbiosis associated with a gastrointestinal disease in a subject, comprising administering a composition comprising a purified population of spore-forming bacteria consisting essentially of a population of germinable bacterial spores produced by the steps of:
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a) providing a fecal material, and b) subjecting the fecal material to a treatment step resulting in purification of germinable bacterial spores, wherein the composition comprises at least 1×
104 colony forming units of germinable bacterial spores per dose of the composition, and wherein the germinable bacterial spores comprise at least two bacterial entities comprising 16S rRNA sequences at least 97% identical to the nucleic acid sequences selected from the group consisting of SEQ ID NO. 673, SEQ ID NO. 674, SEQ ID NO. 774, SEQ ID NO. 845, SEQ ID NO. 847, SEQ ID NO. 848, SEQ ID NO. 856, and SEQ ID NO. 1670,wherein an effective amount of the purified population administered to a subject treats a dysbiosis, prevents the dysbiosis, or reduces a severity of at least one symptom of the dysbiosis in the subject. - View Dependent Claims (11, 12, 13, 22, 23)
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14. A method of preventing the onset a dysbiosis, comprising administering to a human subject a composition comprising a purified population of spore-forming bacteria consisting essentially of a population of germinable bacterial spores in an amount effective to populate a gastrointestinal tract in the subject and augment growth of at least one type of bacteria not detectably present in the composition or in the gastrointestinal tract prior to administration to the subject,
wherein the composition comprises at least 1× - 104 colony forming units of germinable bacterial spores per dose of the composition, and wherein the germinable bacterial spores comprise at least two bacterial entities comprising 16S rRNA sequences at least 97% identical to the nucleic acid sequences selected from the group consisting of SEQ ID NO. 673, SEQ ID NO. 674, SEQ ID NO. 774, SEQ ID NO. 845, SEQ ID NO. 847, SEQ ID NO. 848, SEQ ID NO. 856, and SEQ ID NO. 1670,
thereby providing an amount effective to prevent the onset of the dysbiosis in the gastrointestinal tract in the human subject. - View Dependent Claims (15, 16, 24)
- 104 colony forming units of germinable bacterial spores per dose of the composition, and wherein the germinable bacterial spores comprise at least two bacterial entities comprising 16S rRNA sequences at least 97% identical to the nucleic acid sequences selected from the group consisting of SEQ ID NO. 673, SEQ ID NO. 674, SEQ ID NO. 774, SEQ ID NO. 845, SEQ ID NO. 847, SEQ ID NO. 848, SEQ ID NO. 856, and SEQ ID NO. 1670,
Specification