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Compositions for the restoration of a fecal microbiota and methods for making and using them

A technology of microbiota and excreta, applied in the fields of medicine and gastroenterology, can solve problems such as failure

Inactive Publication Date: 2015-09-16
托马斯·朱利叶斯·波洛迪
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Antibiotics produce temporary improvement but often fail (eg, recurrent CDI), and these failures indicate the need for new treatments

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0168] Example 1: Exemplary "Coarse Filtered" Compositions of the Invention

[0169] In one embodiment, an exemplary composition of the invention is mostly (eg, substantially) whole donor excreta (eg, feces) homogenized with saline into a human fecal extract. Biological material, such as donor excreta (e.g., feces), is obtained, dissolved and homogenized, and passed through a sieve initially with a pore size of 2.0 mm, then progressively passed through: 1.0 mm, 0.5 mm and finally up to 0.1 mm mesh . By stopping at 0.1 mm mesh, this exemplary embodiment is in contrast to WO 2012 / 122478 A1 of Sadowsky et al., which is prepared by continuous filtration through a sieve of even smaller mesh until faeces pass through a sieve of up to 0.020 mm FMT material; this results in an extremely highly purified microbiota mass of well over 95% bacterial cells alone, while discarding the surrounding liquid material (in bacterial cell-only formulations, the goal is to have an essentially bact...

Embodiment 2

[0172] Example 2: Exemplary "High Level Filtration" Compositions of the Invention

[0173] In one embodiment, exemplary compositions of the invention comprise starting material obtained from a donor of a defined donor pool (see below), wherein the donor donates feces that are centrifuged followed by filtration using, for example, metal A strainer or Millipore filter or equivalent is used to filter at an extremely high level, ultimately allowing only cells of bacterial origin to remain, eg often less than about 5 microns in diameter. After the initial centrifugation, the solid material is separated from the fluid, and the solids are then filtered in a progressively reducing size filter and a tangential flow filter, for example using Millipore filtration, and optionally also using nanomembrane filtration. Filtration can also be carried out as described in WO 2012 122478, but in contrast, using a filter mesh of less than 0.0120 mm up to about 0.0110 mm, which ultimately results...

Embodiment 3

[0183] Example 3: Exemplary "culture or incubation" compositions of the invention

[0184] In one embodiment, an exemplary composition of the invention comprises a population of bacteria cultured or incubated with a starting composition as described in Example 1 or 2. In one embodiment, a representative extract of the entire flora as in 1 or 2 (e.g. a substantially complete representative of the human microbiota) is prepared as described herein, for example, in Example 1 or Example 2, but The FMT product is then incubated for a variable period of time, such as from about 2 hours to about 72 hours, or from about 1 hour to 24 hours, or from about 30 minutes to 12 hours, thereby increasing the number of bacteria and their products without using a larger amount of donor. In an alternative embodiment, the flora extract is incubated in a liquid enrichment medium under anaerobic conditions using a nutrient broth of appropriate standard composition. These aliquots can then be froz...

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Abstract

In alternative embodiments, the invention provides compositions and methods for treating various disorders and conditions in mammals, including chronic disorders in which there is a presence of an abnormal microbiota or an abnormal distribution of microflora in the gastrointestinal tract. In alternative embodiments, the invention provides liquid preparations or formulations derived from a human fecal material (e.g., a stool) processed, e.g., filtered and / or centrifuged, such that all bacteria, fungal spores and viruses are removed, but retaining the native biologically active molecules from the fecal material and bacteriophages. In alternative embodiments, the invention provides a "rough-", "incomplete-" or medium- filtered microbiota which still comprises native physiological components or nutritive agents for the bacteria, e.g., retains native biologically and nutritionally active components. In alternative embodiments, the invention provides a highly filtered or substantially purified microbiota in combination with, or having added back, a liquid preparation or formulation of the invention. In alternative embodiments, the invention provides compositions or formulations where the bacteria, or microbiota, component has been cultured, or cultured under anaerobic conditions, or harvested, stored and / or cultured under anaerobic conditions. In alternative embodiments, the invention provides various additives, compositions and donor restrictions for treating these disorders and conditions.

Description

field of invention [0001] The present invention relates generally to medicine and gastroenterology, pharmacology and microbiology. In alternative embodiments, the present invention provides compositions and methods for treating various diseases and conditions in mammals, including chronic conditions in which an abnormal microbiota is present or abnormally distributed in the gastrointestinal tract. disease. In alternative embodiments, the present invention provides fluid preparations or formulations derived from human excreta (e.g. feces) that have been treated (e.g. filtered and / or centrifuged) such that all bacterial, fungal spores are removed and viruses, but retains natural bioactive molecules from feces. In alternative embodiments, the present invention provides "coarsely" filtered, "partially" filtered or moderately filtered microbial populations that still contain the bacteria's natural physiological or nutritional factors, e.g., retain natural bioactive components or...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/24A61K36/8962A61K38/40A61K38/46A61K38/47A61K38/51A61K45/06A61K9/20A61K31/341A61K31/4164A61K31/4439A61K31/485A61K31/606A61K31/635A61K31/655A61K31/706A61K35/38A61K35/74A61K35/741A61K35/742A61K35/744A61K35/76A61K36/28A61K36/31A61K36/48C12N1/20A61P1/00A61P39/00A61K35/745A61K35/747
CPCA61K9/19A61K31/635C12Y302/01052A61K35/744A61K35/74A61K31/655A61K36/48A61K31/341A61K31/4164A61K36/28A61K36/8962A61K36/31A61K38/40A61K9/2004A61K38/51A61K35/38C12N1/20A61K45/06A61K38/465C12Y302/01C12Y301/21001A61K35/76A61K31/606A61K38/47A61K35/741A61K31/485A61K31/4439A61K31/706A61K35/742A61K35/745A61K35/747A61P1/00A61P1/02A61P1/04A61P1/10A61P1/12A61P1/16A61P1/18A61P11/00A61P13/12A61P17/00A61P17/04A61P19/02A61P21/02A61P25/00A61P25/04A61P25/08A61P25/16A61P25/20A61P25/24A61P25/28A61P3/02A61P31/04A61P37/00A61P37/02A61P37/08A61P39/00A61P39/02A61P3/10Y02A50/30A61K2300/00
Inventor 托马斯·朱利叶斯·波洛迪
Owner 托马斯·朱利叶斯·波洛迪
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