Compositions for Fecal Floral Transplantation and Methods for Making and Using Them and Devices for Delivering Them

A method of manufacturing a stool composition comprising viable fecal bacteria from a stool of a healthy human donor, while limiting damage of the fecal bacteria during the manufacture and storage of the stool composition, the method comprising:

• obtaining the stool from the healthy human donor,
• storing the stool below room temperature but above freezing prior to processing the stool at a centralized flora bank,
• processing the stool at the centralized flora bank by adding a cryoprotectant to the stool and homogenizing the stool and the cryoprotectant to form the stool composition, and
• incorporating the stool composition into a container for storage and transport of the stool composition to a location distant from the centralized flora bank,
• wherein the method preserves a number of viable bacteria from the stool sufficient to overcome a Clostridium difficile infection in a patient following administration of the stool composition to the patient.

A method of manufacturing a standardized stool composition comprising viable fecal bacteria from a stool of a healthy human donor, while limiting damage of the fecal bacteria during the manufacture and storage of the standardized stool composition, the method comprising:

• obtaining the stool from the healthy human donor,
• storing the stool below room temperature but above freezing prior to processing the stool at a centralized flora bank,
• processing the stool at the centralized flora bank by adding a cryoprotectant to the stool and homogenizing the stool and the cryoprotectant to form a standardized stool composition, and
• incorporating the standardized stool composition into a container for storage and transport of the standardized stool composition to a location distant from the centralized flora bank,
• wherein the standardized stool composition comprises sufficient viable bacteria from the stool to restore deficient fecal flora in a patient with a Clostridium difficile infection following administration of the standardized stool composition to the patient.