Microbiota restoration therapy (MRT), compositions and methods of manufacture
Microbiota restoration therapy compositions and methods for manufacturing, processing, and/or delivering microbiota restoration therapy compositions are disclosed. An example method for manufacturing a microbiota restoration therapy composition may include collecting a human fecal sample and adding a diluent to the human fecal sample to form a diluted sample. The diluent may include a cryoprotectant. The method may also include mixing the diluted sample with a mixing apparatus and filtering the diluted sample. Filtering may form a filtrate. The method may also include transferring the filtrate to a sample bag and sealing the sample bag.
1. A therapeutic composition comprising:
a population of microbes derived from a fecal sample; and
a cryoprotectant;
wherein the cryoprotectant includes a polyethylene glycol solution having a concentration of 30-90 g/L of polyethylene glycol,
wherein the composition exhibits one or both of the following properties:
(i) the composition has a colony forming unit (CFU) count of said microbes of from about 30 to about 300 CFU at a serial dilution of 10 −6 when cultured on a Center for Disease Control (CDC) culture plate, and
(ii) the composition has a colony forming unit (CFU) count of said microbes of from about 30 to about 300 CFU at a serial dilution of 10 −5 when cultured on a Bacteroides Bile Esculin Agar (BBE) culture plate.
2. The composition of claim 1 , wherein the composition has a colony forming unit (CFU) count of said microbes of about 30 to about 300 CFU at a serial dilution of 10 −6 when cultured on a Center for Disease Control (CDC) culture plate.
3. The composition of claim 1 , wherein the composition has a colony forming unit (CFU) count of said microbes of about 30 to about 300 CFU at a serial dilution of 10 −5 when cultured on a Bacteroides Bile Esculin Agar (BBE) culture plate.
4. The composition of claim 1 , wherein 36-48% of the population of microbes includes bacteria from the family Bacteroidaceae.
5. The composition of claim 1 , wherein the composition includes bacteria from at least seven different families.
6. The composition of claim 1 , wherein the composition has a Shannon Diversity Index of 0.4-2.5 when calculated at the family level.
7. The composition of claim 1 , wherein the composition is formulated as a liquid for enema administration.
8. The composition of claim 1 , wherein the composition is formulated as a solid for oral administration.
9. The composition of claim 1 , wherein the composition is freeze dried.
10. A composition for displacing a pathogenic organism in the digestive tract, comprising:
a population of microbes derived from a fecal sample; and
a diluent comprising a polyethylene glycol solution having a concentration of 30-90 g/L of polyethylene glycol,
wherein the composition exhibits one or both of the following properties:
(i) the composition has a colony forming unit (CFU) count of said microbes of about 30 to about 300 CFU at a serial dilution of 10 −6 when cultured on a Center for Disease Control (CDC) culture plate, and
(ii) the composition has a colony forming unit (CFU) count of said microbes of about 30 to about 300 CFU at a serial dilution of 10 −5 when cultured on a Bacteroides Bile Esculin Agar (BBE) culture plate.
11. The composition of claim 10 , wherein the composition has a colony forming unit (CFU) count of said microbes of about 30 to about 300 CFU at a serial dilution of 10 −6 when cultured on a Center for Disease Control (CDC) culture plate.
12. The composition of claim 10 , wherein the composition has a colony forming unit (CFU) count of said microbes of about 30 to about 300 CFU at a serial dilution of 10 −5 when cultured on a Bacteroides Bile Esculin Agar (BBE) culture plate.
13. The composition of claim 10 , wherein 36-48% of the population of microbes includes bacteria from the family Bacteroidaceae.
14. The composition of claim 10 , wherein the composition includes bacteria from at least seven different families.
15. The composition of claim 10 , wherein the composition has a Shannon Diversity Index of 0.4-2.5 when calculated at the family level.
16. The composition of claim 10 , wherein the composition is formulated as a liquid for enema administration.
17. The composition of claim 10 , wherein the composition is formulated as a solid for oral administration.
18. The composition of claim 10 , wherein the composition is freeze dried.
19. A composition, comprising:
a population of microbes derived from a fecal sample; and
a cryoprotectant, wherein the cryoprotectant includes a polyethylene glycol solution having a concentration of 30-90 g/L of polyethylene glycol,
wherein the composition is formed by mixing the population of microbes with the cryoprotectant, and
wherein the composition exhibits one or both of the following properties:
(i) the composition has a colony forming unit (CFU) count of said microbes of about 30 to about 300 CFU at a serial dilution of 10 −6 when cultured on a Center for Disease Control (CDC) culture plate, and
(ii) the composition has a colony forming unit (CFU) count of said microbes of about 30 to about 300 CFU at a serial dilution of 10 −5 when cultured on a Bacteroides Bile Esculin Agar (BBE) culture plate.
20. The composition of claim 19 , wherein the composition is formulated as a liquid for enema administration or a solid for oral administration.