# US 8,785,160 B2 · Prebiotic formulations and methods of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,785,160 B2 - Document ID: US8785160B2 - Status: Granted - Kind: B2 - Application number: 13/096,711 - Filed: 2011-04-28 - Published: 2011-09-29 - Granted: 2014-07-22 - Earliest claimed: 2009-02-24 - Assignees: Ritter Pharmaceuticals, Inc. - Applicants: Andrew J. Ritter; Dennis Savaiano; David Barnes; Todd Klaenhammer - Inventors: Andrew J. Ritter; Dennis Savaiano; David Barnes; Todd Klaenhammer - Web page: https://patentgrep.com/patent/US8785160B2 ## CPC - A61K 31/702: Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages - A23L 33/10: using additives (addition of substantially indigestible substances A23L33/21) - A23L 33/135: Bacteria or derivatives thereof, e.g. probiotics - A23L 33/21: Addition of substantially indigestible substances, e.g. dietary fibres - A61K 9/4825: {Proteins, e.g. gelatin (gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816)} - A61K 9/4891: {Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004)} - A61K 31/715: Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters - A61K 35/742: Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes - A61K 35/744: Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs - A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system - A61P 1/08: for nausea, cinetosis or vertigo; Antiemetics - A61P 1/14: Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents - A61P 19/10: for osteoporosis - A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs - Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION - Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE ## Abstract The invention provides methods and pharmaceutical compositions for treating symptoms associated with lactose intolerance and for overall improvement in gastrointestinal health. Described herein are methods and pharmaceutical compositions for improving overall gastrointestinal health or for decreasing symptoms of lactose intolerance by administering to subject in need thereof a pharmaceutical composition comprising a prebiotic, optionally in combination with effective amount of a probiotic microbe or microbes. ## Claims ### Claim 1 A method of treating lactose intolerance in a subject who has experienced one or more symptoms of lactose intolerance comprising: a) administering a hydrogen breath test (HBT) to said subject; b) diagnosing said subject as having lactose intolerance based upon a HBT result; and, c) administering from about 0.1 g to about 20 g of a pharmaceutical composition to said subject diagnosed as having lactose intolerance based upon said HBT result, wherein said pharmaceutical composition comprises at least 50% galactooligosaccharides (GOS) by weight. ### Claim 2 (depends on 1) The method of claim 1, wherein said subject is diagnosed as having lactose intolerance if said HBT result is an increase in breath hydrogen of 12 ppm or greater from a baseline level of breath hydrogen. ### Claim 3 (depends on 1) The method of claim 1, wherein said subject is diagnosed as having lactose intolerance if said HBT result is an increase in breath hydrogen of 15 ppm or greater from a baseline level of breath hydrogen. ### Claim 4 (depends on 1) The method of claim 1, wherein said subject is diagnosed as having lactose intolerance if said HBT result is an increase in breath hydrogen of 20 ppm or greater from a baseline level of breath hydrogen. ### Claim 5 (depends on 1) The method of claim 1, further comprising administering a lactose intolerance diagnostic questionnaire to said subject and wherein diagnosing said subject as having lactose intolerance is further based upon a lactose intolerance diagnostic questionnaire result. ### Claim 6 (depends on 1) The method of claim 1, wherein at least about 95% of the total weight of said pharmaceutical composition is GOS. ### Claim 7 (depends on 1) The method of claim 1, wherein said pharmaceutical composition does not comprise a probiotic. ### Claim 8 (depends on 1) The method of claim 1, wherein said pharmaceutical composition is provided in a dosing unit. ### Claim 9 (depends on 1) The method of claim 1, wherein said subject is a human subject. ### Claim 10 (depends on 1) The method of claim 1, wherein said subject has a calcium deficiency. ### Claim 11 (depends on 1) The method of claim 1, wherein said pharmaceutical composition is administered each day for a predetermined number of days. ### Claim 12 (depends on 11) The method of claim 11, wherein said predetermined number of days is from about 7 days to about 60 days. ### Claim 13 (depends on 1) The method of claim 1, wherein said one or more symptoms of lactose intolerance comprise flatulence, heartburn, upset stomach, nausea, bloating, diarrhea, abdominal pain, cramping, or vomiting. ### Claim 14 (depends on 1) The method of claim 1, wherein said subject is diagnosed as having lactose intolerance if said HBT result is an increase in breath hydrogen of 10 ppm or greater from a baseline level of breath hydrogen. ### Claim 15 (depends on 1) The method of claim 1, wherein at least about 60% of the total weight of said pharmaceutical composition is GOS. ### Claim 16 (depends on 1) The method of claim 1, wherein at least about 80% of the total weight of said pharmaceutical composition is GOS. ### Claim 17 A method of treating lactose intolerance in a subject who has experienced one or more symptoms of lactose intolerance, said method comprising: a) administering a diagnostic questionnaire to said subject, optionally in conjunction with a lactose or milk challenge; b) diagnosing said subject as having lactose intolerance based upon a diagnostic questionnaire result, wherein said diagnostic questionnaire result comprises subject-indicated severity scores for each of said one or more symptoms of lactose intolerance; and, c) administering from about 0.1 g to about 20 g of a pharmaceutical composition to said subject diagnosed as having lactose intolerance based upon said diagnostic questionnaire result, wherein said pharmaceutical composition comprises at least 50% GOS by weight. ### Claim 18 A method of treating lactose intolerance in a subject who has experienced one or more symptoms of lactose intolerance comprising: a) diagnosing said subject as having lactose intolerance, wherein said diagnosing comprises a HBT test, a stool acidity test, a blood glucose test, a lactose challenge, a milk challenge, a diagnostic questionnaire, a self-reported history of having symptoms of lactose intolerance, or a combination thereof; and b) administering from about 0.1 g to about 20 g of a pharmaceutical composition comprising indigestible oligosaccharides to said subject diagnosed as having lactose intolerance, wherein said pharmaceutical composition comprising indigestible oligosaccharides selectively promotes growth of beneficial bacteria in the gastrointestinal tract of said subject, wherein said indigestible oligosaccharides comprise GOS and wherein at least 50% of said pharmaceutical composition by weight is GOS. ### Claim 19 (depends on 18) The method of claim 18, wherein said pharmaceutical composition comprising indigestible oligosaccharides promotes growth of said beneficial bacteria to a greater extent than E. coli or other coliform bacteria. ### Claim 20 (depends on 18) The method of claim 18, wherein said indigestible oligosaccharides further comprise fructooligosaccharides, inulin, lactulose, raffinose, stachyose, or a combination thereof. ### Claim 21 A method for treating lactose intolerance in a subject who has experienced one or more symptoms of lactose intolerance, said method comprising administering an effective amount of a pharmaceutical composition comprising at least 50% GOS by weight to said subject, wherein said effective amount of said pharmaceutical composition administered to said subject is based on said subject's weight. ### Claim 22 A method for treating a subject who has experienced one or more symptoms comprising flatulence, heartburn, upset stomach, nausea, bloating, diarrhea, abdominal pain, cramping, or vomiting, the method comprising administering from about 0.1 g to about 20 g of a pharmaceutical composition comprising at least 50% GOS by weight and less than 20% digestible saccharides by weight to said subject, wherein said subject experiences a decrease in at least one of said one or more symptoms. ### Claim 23 (depends on 22) The method of claim 22, wherein said decrease in said at least one of said one or more symptoms is about a 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, or 100% decrease. ### Claim 24 (depends on 22) The method of claim 22, wherein said decrease in at least one of said symptoms persists for at least about a day, a week, or a month. ### Claim 25 (depends on 22) The method of claim 22, wherein said subject has a psychological aversion to dairy products and wherein said subject experiences a decrease in said psychological aversion to dairy products. ### Claim 26 (depends on 22) The method of claim 22, wherein said pharmaceutical composition comprises at least 60% GOS by weight. ### Claim 27 (depends on 22) The method of claim 22, wherein said pharmaceutical composition comprises at least 70% GOS by weight. ### Claim 28 (depends on 22) The method of claim 22, wherein said pharmaceutical composition comprises at least 80% GOS by weight. ### Claim 29 (depends on 22) The method of claim 22, wherein said pharmaceutical composition comprises at least 90% GOS by weight. ### Claim 30 (depends on 22) The method of claim 22, wherein said pharmaceutical composition comprises at least 95% GOS by weight. ### Claim 31 (depends on 22) The method of claim 22, wherein said pharmaceutical composition comprises less than 9% digestible saccharides by weight.