Compositions for fecal floral transplantation and methods for making and using them and devices for delivering them
View Patent ↗In alternative embodiments, the invention provides compositions, e.g., formulations, used for gastric, gastrointestinal and/or colonic treatments or lavage, e.g., orthostatic lavage, e.g., for inducing the purgation (e.g., cleansing) of a gastrointestinal (GI) tract, including a colon; and methods for making and using them. In alternative embodiments, compositions and methods of the invention are used for the stabilization, amelioration, treatment and/or prevention of constipation, for the treatment of abdominal pain, particularly non-specific abdominal pain, and diarrhea, including diarrhea caused by a drug side effect, a psychological condition, a disease or a condition such as Crohn's Disease, a poison, a toxin or an infection, e.g., a toxin-mediated traveler's diarrhea, or C. difficile or the pseudo-membranous colitis associated with this infection. In alternative embodiments, the invention provides pharmaceuticals and products (articles) of manufacture for delivering these compositions and formulations to an individual, e.g., a human or an animal. The invention also provides devices for delivering a fecal material to a patient.
1. An oxygen-free or substantially oxygen-free pharmaceutical preparation, comprising:
(a) a formulation comprising:
(i) a frozen, freeze-dried, spray-dried, lyophilized or powdered entire or at least 90% anaerobic microorganism population of a complete microbiota of a fecal sample; or
(ii) all or at least 90% anaerobic microorganism population of a complete microbiota of a fecal sample in an excipient, a saline, a buffer, a buffering agent or medium, or a fluid-glucose-cellobiose agar (RGCA) medium,
(b) an oxygen scavenging material, and
(c) an air tight or an anaerobic container,
wherein the pharmaceutical preparation provides an at least about 99.5% oxygen-free or oxygen-free containment or storage of the anaerobic microorganism population of (a)(i) or (a)(ii) in the air tight or the anaerobic container.
2. The pharmaceutical preparation of claim 1 , wherein the anaerobic microorganism population of (a)(i) or (a)(ii) comprise a human anaerobic fecal flora.
3. The pharmaceutical preparation of claim 1 , having contained therein a built-in or a clipped-on oxygen-scavenging mechanism.
4. The pharmaceutical preparation of claim 1 , wherein the pharmaceutical preparation or the air tight or anaerobic container is coated with an oxygen scavenging material.
5. The pharmaceutical preparation of claim 1 , wherein the pharmaceutical preparation or the air tight or anaerobic container comprises an inert non-reactive gas or gases.
6. The pharmaceutical preparation of claim 1 , wherein the formulation is for human or animal use or for a veterinary use.
7. The pharmaceutical preparation of claim 1 , wherein the formulation further comprises a stabilizing agent or a glycerol.
8. The pharmaceutical preparation of claim 1 , wherein the pharmaceutical preparation is capable of being re-formulated for final delivery as comprising a liquid, a suspension, a gel, a geltab, a semisolid, a tablet, a sachet, a lozenge or a capsule, or as an enteral formulation.
9. The pharmaceutical preparation of claim 1 , wherein the anaerobic microorganism population of (a)(i) or (a)(ii) are free or substantially free of rough fecal particulate matter or non-floral matter.
10. The pharmaceutical preparation of claim 1 , wherein the anaerobic microorganism population of (a)(i) or (a)(ii) are initially derived from an individual screened or tested for a disease or infection, or are initially derived from an individual screened to have a normal, healthy or wild type population of fecal flora.
11. The pharmaceutical preparation of claim 1 , wherein the anaerobic microorganism population of (a)(i) or (a)(ii) are at least about 90% isolated or pure, or having no more than 1.0% non-fecal floral material.
12. The pharmaceutical preparation of claim 1 , wherein the anaerobic microorganism population of (a)(i) or (a)(ii) are formulated for or calibrated for repeat or multiple implantations, administration, delivery or infusions.
13. The pharmaceutical preparation of claim 1 , wherein the anaerobic microorganism population of (a)(i) or (a)(ii) are formulated with or mixed with a saline, a defoaming agent, a surfactant agent, a lubricant, an acid neutralizer, a marker, a cell marker, a drug, an antibiotic, a contrast agent, a dispersal agent, a buffer or a buffering agent, a sweetening agent, a debittering agent, a flavoring agent, a pH stabilizer, an acidifying agent, a preservative, a desweetening agent, coloring agent, at least one vitamin, mineral supplement, a dietary supplement, a prebiotic nutrient or any combination thereof.
14. The pharmaceutical preparation of claim 1 , wherein the pharmaceutical preparation is made substantially or completely oxygen-free by completely or substantially replacing the air in the pharmaceutical preparation with nitrogen.
15. A product of manufacture, comprising:
(a) a formulation comprising a frozen, freeze-dried, spray-dried, lyophilized or powder-processed entire or at least 90% anaerobic microorganism population of a complete microbiota of a fecal sample,
(b) an oxygen scavenging material, and
(c) an air tight or an anaerobic container,
wherein the product of manufacture provides an at least about 99.5% oxygen-free or oxygen-free containment or storage of the anaerobic microorganism population of (a)(i) or (a)(ii) in the air tight or the anaerobic container.
16. A product of manufacture, comprising:
(a) a formulation comprising entire or at least 90% anaerobic microorganism population of a complete microbiota of a fecal sample in an excipient, a saline, a buffer, a buffering agent or medium, or a fluid-glucose-cellobiose agar (RGCA) medium,
(b) an oxygen scavenging material, and
(c) an air tight or an anaerobic container,
wherein the product of manufacture provides an at least about 99.5% oxygen-free or oxygen-free containment or storage of the anaerobic microorganism population of (a)(i) or (a)(ii) in the air tight or the anaerobic container.
17. The pharmaceutical preparation of claim 1 , wherein the formulation is enhanced with one or more additional bacterial species.
18. The pharmaceutical preparation of claim 17 , wherein the one or more additional bacterial species are selected from the group consisting of a Bacteroides species, a Firmicutes species, and Bacillus thuringiensis.