Compositions and methods

A technology of therapeutic composition and product, applied in the direction of botany equipment and method, drug combination, drug delivery, etc., can solve the problems of being narrow and unable to fully replace the natural microbial flora

Inactive Publication Date: 2016-03-30
SERES HEALTH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, probiotics are restricted to a very narrow genera and a correspondingly limited number of species; thus, in many cases they cannot adequately replace the missing natural microflora of the gastrointestinal tract

Method used

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  • Compositions and methods
  • Compositions and methods
  • Compositions and methods

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0308] Example 1. Provision of fecal material

[0309] Fresh stool samples were obtained from healthy human donors who had been screened for general good health and the absence of infectious diseases and met the inclusion and exclusion criteria, which included being in good general health with no apparent history, physical examination findings, or clinical laboratory abnormalities, regular bowel movements, stool appearance typically Type 2, 3, 4, 5, or 6 on the Bristol Stool Scale, and a BMI ≥ 18 kg / m 2 And ≤25kg / m 2 . Exclusion criteria generally included significant chronic or acute medical conditions, including renal, hepatic, pulmonary, gastrointestinal, cardiovascular, genitourinary, endocrine, immune, metabolic, neurological, or hematological disorders, inflammatory bowel disease including Crohn's disease and Family history of ulcerative colitis, irritable bowel syndrome, colon, gastric, or other gastrointestinal malignancies, or gastrointestinal polyposis syndrome, ...

Embodiment 2

[0311] Example 2. Purification of spores from alcohol treatment of fecal material

[0312] A 10% w / v suspension of human fecal material in PBS was mixed with absolute ethanol in a 1:1 ratio and vortexed to mix for 1 min. The suspension was incubated at 37°C for 1 hour. After incubation, the suspension was centrifuged at 13,000 rpm for 5 minutes to pellet the spores. The supernatant was discarded and the pellet was resuspended in an equal volume of PBS. Glycerol was added to a final concentration of 15% and the purified spore fraction was then stored at -80°C.

Embodiment 2A

[0313] Example 2A. Production of spore preparations from alcohol treatment of fecal material

[0314] A 10% w / v suspension of human fecal material in PBS was mixed with absolute ethanol in a 1:1 ratio and vortexed to mix for 1 min. The suspension was incubated at 37°C for 1 hour. After incubation, the suspension was centrifuged at 13,000 rpm for 5 minutes to concentrate the spores into pellets containing a purified spore-containing preparation. The supernatant was discarded and the pellet was resuspended in an equal volume of PBS. Glycerol was added to a final concentration of 15% and the purified spore preparation was then stored at -80°C.

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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.

Description

[0001] related application [0002] This application claims U.S. Provisional Application No. 61 / 760,584 filed February 4, 2013 and U.S. Provisional Application No. 61 / 760,585 filed February 4, 2013 and U.S. Provisional Application No. 61 / 760,585 filed February 4, 2013 Priority to 61 / 760,574 and U.S. Provisional Application Nos. 61 / 760,606, filed February 4, 2013 and 61 / 926,918, filed January 13, 2014. These applications are incorporated by reference in their entirety for all purposes. [0003] References to Sequence Listings [0004] This application includes a Sequence Listing filed electronically in a text file named 25970PCT_sequencelisting.txt, which was created on February 2, 2014 and is 4,100,000 bytes in size. The sequence listing is incorporated by reference. Background technique [0005] Microbes colonize the gastrointestinal (GI) tract of mammals, on the skin, and in other epithelial and tissue habitats such as the oral cavity, ocular surfaces, and vagina. The...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A01N63/00A01N65/00
CPCC12N1/20A61K35/74A61K35/742A61P1/00A61P1/04A61P1/12A61P31/04Y02A50/30A61K9/0053A61K9/48A61K35/741A61K35/744A61K35/745A61K35/747A61K45/06A61K9/4816A61K35/37
Inventor G·麦肯齐M-J·L·麦肯齐D·库克M·武利克G·冯马尔特扎恩B·戈德曼J·G·奥宁斯M·R·赫恩D·A·贝瑞J·温科勒
Owner SERES HEALTH
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