Method to Improve The Health Of The Microbiome In A Human Gastrointestinal System and Multi-Chamber Probiotic Delivery Products Therefor

Abstract

A method for treating the gastro-intestinal or a urogenital system of a subject with prebiotic nutrients and probiotic bacteria is provided. Multi-chamber products are described which include at least two chambers wherein probiotic bacteria or human microbiome transplants are contained in one or more inner chambers and wherein prebiotic nutrients are contained in an outer chamber, the outer chamber completely enclosing the inner chamber(s). One or both chambers may contain a pharmaceutically acceptable material that is solid outside the human body when in a dry environment, but that melts at internal body temperature. The products may be administered by oral, rectal, vaginal, or urethral routes.

1 . A method for delivering probiotic bacteria to the gastrointestinal system or urogenital system of a subject in need thereof comprising the steps of:
 first administering to the gastrointestinal system or urogenital system of the subject a prebiotic nutrient in an amount effective to improve the receptivity of the gastrointestinal system or urogenital system to probiotic bacteria, and   second, administering probiotic bacteria to the gastrointestinal system or urogenital system of the subject   wherein the prebiotic nutrient and the probiotic bacteria are administered in a multi-chamber dosage form comprising:   a) an inner chamber containing one or more species of freeze-dried probiotic bacteria;   b) a pharmaceutically acceptable matrix material that is solid at room temperature when in a dry environment, but that melts at body temperature when in contact with the mucosa of the rectum or vagina of the subject, wherein the matrix material fully encloses the inner chamber;   wherein the matrix material contains prebiotic nutrients for said probiotic bacteria and a mixture of fatty acids that are solid at room temperature but melt at a subject's body temperature.   
     
     
         2 . The method according to  claim 1 , wherein the prebiotic nutrient is selected from the group consisting of plant-derived oils, animal-derived oils and fatty acids, fruit vinegars, acetic acid, butyric acid, butyrate, complex carbohydrates, fibers, apple cider vinegar, iron, calcium, potassium, vitamin B12, vitamin C and vitamin K, polyethylene glycol, hydrogels, cocoa butter, glycerinated gelatin, shea butter, petrolatum, mineral oil, shark liver oil, Vitamin A, Vitamin B 6 , Vitamin D, Vitamin K 2  (MK 1), potassium, folic acid, L-carnitine, quercetin, magnesium, calcium, alpha-lipoic acid, fiber, omega-3 fatty acids, nuclear factor-like 2 activators, L-glutathione, L-glutamate and gamma-aminobutyric acid, lemon juice, lactic acid, chamomile, coenzyme Q-10, collagen, gelatin, green tea extract, lactose, galactose, fructose, fructose oligosaccharides, iso-maltose, dextrose, glucose, amylopectin, inulin, resistant starch, corn starch, oligosaccharides, rosemary leaf extract, oregano oil, curcumin, coffee, ginger, flax seed oil, green barley, agrimony, aniseed-basil, aniseed-fennel, cayenne,  Echinacea , garlic, honey, molasses, horseradish, lavender, marshmallow, olive oil, milk, peppermint, slippery elm, buttermilk, goldenrod, St John's wort, uva  ursi , yarrow, bee pollen, bee propolis, mint and mixtures thereof. 
     
     
         3 . The method according to  claim 1 , wherein the prebiotic nutrient is apple cider vinegar. 
     
     
         4 . The method according to  claim 1 , wherein the prebiotic nutrient is blended into a mixture of fatty acids containing at least 90 wt. % saturated fatty acids. 
     
     
         5 . The method according to  claim 4 , wherein at least 50 wt. % of the saturated fatty acids of the mixture of fatty acids is lauric acid. 
     
     
         6 . The method according to  claim 4 , wherein the mixture of fatty acids includes coconut oil. 
     
     
         7 . The method according to  claim 1 , wherein the probiotic bacteria comprises one or more purified bacterial species and strains selected from the group consisting of  Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus brevis, Lactobacillus gasseri, Bifidobacterium longum, Lactobacillus salivarius, Lactobacillus casei, Lactobacillus jensenii, Lactobacillus lactis, Bifidobacterium bifidum, Streptococcus thermophilus , and mixtures thereof. 
     
     
         8 . The method according to  claim 1  wherein the probiotic bacteria include human microbiome transplant samples collected from the human colon, rectum, vagina, urethra, skin, mouth, or throat. 
     
     
         9 . (canceled) 
     
     
         10 . A multi-chamber dosage form comprising:
 a) an inner chamber containing one or more species of probiotic;   b) a pharmaceutically acceptable matrix material that is solid at room temperature when in a dry environment, but that melts at body temperature when in contact with the mucosa of the rectum or vagina of the subject, wherein the matrix material fully encloses the inner chamber;   wherein the matrix material contains prebiotic nutrients for said probiotic bacteria and a mixture of fatty acids that are solid at room temperature but melt at a subject's body temperature, and   wherein the dosage form is a capsule, a capsule embedded in suppository, a capsule embedded in prefilled applicator or a capsule embedded in prefilled sealed pouch.   
     
     
         11 . The multi-chamber dosage form of  claim 10 , wherein said source of prebiotic nutrients comprises apple cider vinegar. 
     
     
         12 . The multi-chamber dosage form of  claim 10 , wherein said mixture of fatty acids comprises at least 90 wt. % of saturated fatty acids. 
     
     
         13 . The multi-chamber dosage form of  claim 10 , wherein at least 50 wt. % of the saturated fatty acids of said mixture of fatty acids is lauric acid. 
     
     
         14 . The multi-chamber dosage form of  claim 10 , wherein said mixture of fatty acids comprises coconut oil. 
     
     
         15 . The multi-chamber dosage form of  claim 10 , wherein said probiotic bacteria comprise one or more species of bacteria selected from the group consisting of  Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus brevis, Bifidobacterium longum, Lactobacillus salivarius, Lactococcus lactis, Lactobacillus reuterii, Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Bacillus coagulans, Lactobacillus bulgaricus, Lactobacillus gasseri, Bifidobacterium bifidum  and mixtures thereof. 
     
     
         16 - 25 . (canceled) 
     
     
         26 . A method for delivering probiotic bacteria to the gastrointestinal system or urogenital system of a subject in need thereof comprising the steps of:
 first administering to the gastrointestinal system or urogenital system of the subject a prebiotic nutrient in an amount effective to improve the receptivity of the gastrointestinal system or urogenital system to probiotic bacteria, and   second, administering probiotic bacteria to the gastrointestinal system or urogenital system of the subject,   wherein the probiotic bacteria is administered to the gastrointestinal system or urogenital system about 30 seconds after the prebiotic nutrient is administered to the gastrointestinal system or urogenital system.   
     
     
         27 . A method for delivering probiotic bacteria to an area of the gastrointestinal system or urogenital system of a subject in need thereof comprising the steps of:
 first administering to the area of the gastrointestinal system or urogenital system of the subject a prebiotic nutrient in an amount effective to improve the receptivity of the area of the gastrointestinal system or urogenital system to probiotic bacteria, and   second, administering probiotic bacteria to the area of the gastrointestinal system or urogenital system of the subject containing the prebiotic nutrient,   wherein the probiotic bacteria is administered to the gastrointestinal system or urogenital system about 30 seconds after the prebiotic nutrient is administered to the gastrointestinal system or urogenital system.