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US 2020/0046777 A1Published application
Autologous fecal sample for use in the treatment of microbial dysbiosis
AssigneeBactaviva AB
InventorsHans, Peter, Torsten EKRE, Lars, Georg ENGSTRAND, Ola, Gosta FLINK, Otto, Sten, Gunnar SKOLLING
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Abstract
The present disclosure relates to the use of autologous fecal samples obtained from a subject for use in prevention and/or treatment of microbial dysbiosis in the gastrointestinal tract in said subject and to related pharmaceutical compositions for oral administration. The disclosed autologous fecal samples are useful for treatment of microbial dysbiosis in the gastrointestinal tract associated with medical treatment and/or various indications, including chronic disease and infectious disease, for example Clostridium difficile infection.
Claims21
1:
- A method for prevention and/or treatment of microbial dysbiosis in the gastrointestinal tract comprising orally administering to a subject in need thereof a therapeutically effective amount of an autologous fecal sample which comprises at least one desired species of live microorganisms, wherein said method comprises 1-10 oral administration events per day during 1-30 days, wherein said sample is obtained from said subject while in healthy condition or said state of remission and wherein said sample comprises the unselected diversity of live microorganisms of the gastrointestinal tract of said subject.
2:
- Method for prevention and/or treatment of microbial dysbiosis according to claim 1, wherein said at least one desired species of live microorganisms is present in the gastrointestinal tract of said subject when in a healthy condition or, wherein said at least one desired species of live microorganisms is present in the gastrointestinal tract of said subject when in a state of remission in the case said subject suffers from a chronic disease.
3:
- Pharmaceutical composition for oral administration comprising a therapeutically effective amount of an autologous fecal sample, obtained from a subject and comprising at least one desired species of live microorganisms, and at least one pharmaceutically acceptable excipient, for use in a method for prevention and/or treatment of microbial dysbiosis in the gastrointestinal tract in said subject in need thereof, wherein said method comprises 1-10 administration events per day during 1-30 days, wherein said sample is obtained from said subject while in healthy condition or state of remission and wherein said sample comprises the unselected diversity of live microorganisms of the gastrointestinal tract of said subject.
4:
- Method for prevention and/or treatment of microbial dysbiosis according to claim 1, wherein said prevention and/or treatment comprises autologous reconstitution of normal microbiota of the gastrointestinal tract.
5:
- Method for prevention and/or treatment of microbial dysbiosis according to claim 1, wherein the autologous reconstitution comprises repopulation of the gastrointestinal tract with said at least one species of microorganisms.
6:
- Method for prevention and/or treatment of microbial dysbiosis according to claim 1, wherein said microbial dysbiosis is caused by medical treatment.
7:
- Method for prevention and/or treatment of microbial dysbiosis according to claim 6, wherein said medical treatment is antibiotic treatment.
8:
- Method for prevention and/or treatment of microbial dysbiosis according to claim 6, wherein said medical treatment is selected from the group consisting of immunosuppressive treatment;
- cytostatic treatment;
- radiation treatment;
- surgical treatment;
- and treatment with biguanides.
2 more elements
9:
- Method for prevention and/or treatment of microbial dysbiosis according to claim 6, wherein said medical treatment, is earlier medical treatment.
10:
- Method for prevention and/or treatment of microbial dysbiosis according to claim 9, wherein said oral administration begins at least 1 day after completion of the antibiotic treatment.
11:
- Method for prevention and/or treatment of microbial dysbiosis according to claim 1, wherein said microbial dysbiosis is associated with a disease selected from the group consisting of chronic diseases affecting the gastrointestinal tract and infectious diseases affecting the gastrointestinal tract.
12:
- Method for prevention and/or treatment of microbial dysbiosis according to claim 1, wherein said microbial dysbiosis is associated with an infectious disease selected from the group consisting of infection by Clostridium, Salmonella, EHEC, ETEC, Klebsiella or Shigella;
- infection by calicivirus or ROTA-virus;
- and infection by Crytosporidium or Giardia.
(canceled)
14:
- Method for prevention and/or treatment of microbial dysbiosis according to claim 1, wherein said administration is continued for a period of at least 5 days.
15:
- Pharmaceutical composition for oral administration according to claim 3, which is formulated as a capsule, a pill, or a tablet.
16:
- Pharmaceutical composition for oral administration according to claim 3, wherein said therapeutically effective amount comprises at least 1×107 CFU of said microorganisms per administration event.
17:
- Pharmaceutical composition for use according to claim 3, which is stable at 4-10° C. for a period of at least 10 days.
18:
- Kit comprising i) the pharmaceutical composition according to claim 3 and ii) an additional therapeutic agent and/or an additional agent effective to promote bacterial repopulation.
19-20. (canceled)
21:
- Method for prevention and/or treatment of microbial dysbiosis according to claim 1, wherein said prevention and/or treatment comprises autologous reconstitution of normal microbiota downstream of the duodenum and wherein the autologous reconstitution comprises repopulation of the gastrointestinal tract downstream of the duodenum with said at least one species of microorganisms.
22:
- Method for prevention and/or treatment of microbial dysbiosis according to claim 1, wherein said microbial dysbiosis is associated with an infectious disease affecting the gastrointestinal tract caused by a bacterial infection by Clostridium.
Dependencies are inferred from the claim text.