Methods of treating celiac disease

Abstract

Described herein are compositions which include digestive enzymes and which are formulated to reduce one or more symptoms of Celiac disease. Also described herein is a method for treating a subject with Celiac disease using digestive enzymes and their derivatives to alleviate the symptoms of Celiac disease. The method comprises administering to the individual an effective amount of digestive enzymes that are either naturally or recombinantly derived, or their derivatives, in an amount effective to reduce one or more symptoms of Celiac disease.

What is claimed is: 
     
         1 . A method for preventing or treating Celiac disease or a related disorder in an individual, comprising administering a therapeutically effective amount of a composition that comprises digestive enzymes to the individual, wherein the one or more symptoms of Celiac disease or a related disorder are treated. 
     
     
         2 . The method of  claim 1  wherein the composition is administered until one or more symptoms of Celiac disease or a related disorder are partially or completely resolved 
     
     
         3 . The method of  claim 2 , wherein the one or more symptoms are selected from the group consisting of abdominal pain, bloating, gas, or indigestion, constipation, decreased appetite, diarrhea, lactose intolerance, nausea and vomiting, unexplained weight loss, bruising easily, depression, anxiety, chronic headaches, migraines, fatigue, growth delay in children, hair loss, itchy skin, missed menstrual periods, mouth ulcers, muscle cramps and joint pain, nosebleeds, seizures, tingling or numbness in the hands or feet, unexplained short height, defects in the tooth enamel and changes in tooth color, delayed puberty, irritable and fussy behavior, poor weight gain, slowed growth and shorter than normal height, or a combination thereof. 
     
     
         4 . The method of  claim 1 , wherein the one or more symptoms are reduced in severity or duration by about 2%, about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 90%, about 95%, or about 100%. 
     
     
         5 . The method of  claim 2 , wherein the composition is administered 1, 2, 3 or 4 times a day until one or more symptoms are partially or completely resolved. 
     
     
         6 . The method of  claim 2 , wherein the composition is administered 1, 2, 3 or 4 times a week until one or more symptoms are partially or completely resolved. 
     
     
         7 . The method of  claim 1 , wherein the method further comprises administering one or more additional agents or treatment regimens. 
     
     
         8 . The method of  claim 7 , wherein the one or more additional agents or treatment regimens comprises IgA or a gluten-free diet. 
     
     
         9 . The method of  claim 1 , wherein the composition comprising digestive enzymes comprises amylases, lipases, proteases, or a combination thereof. 
     
     
         10 . The method of  claim 9 , wherein the composition further comprises chymotrypsin, trypsin, pancreatin, papain, or a combination thereof. 
     
     
         11 . The method of  claim 9 , wherein the digestive enzymes are derived from a source selected from the group consisting of animal enzymes, plant enzymes, synthetic enzymes, and a combination thereof. 
     
     
         12 . The method of  claim 11 , wherein the animal enzyme is derived from a mammal. 
     
     
         13 . The method of  claim 12 , wherein the mammal is a pig. 
     
     
         14 . The method of  claim 11 , wherein the animal enzyme is derived from a pancreas. 
     
     
         15 . The method of  claim 1 , wherein the compositions comprising digestive enzymes are manufactured using a technology selected from the group consisting of enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation, and a combination thereof. 
     
     
         16 . The method of  claim 1 , wherein the composition is administered orally. 
     
     
         17 . The method of  claim 1 , wherein the composition is a dosage formulation selected from the group consisting of pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, suppository and a combination thereof. 
     
     
         18 . The method of  claim 9 , wherein the total amount of protease in the composition is from about 10,000 to about 1,500,000; from about 25,000 to about 1,000,000; from about 50,000 to about 750,000; from about 75,000 to about 500,000; from about 85,000 to about 250,000; from about 95,000 to about 200,000; or from about 110,000 to about 150,000 U.S.P. units/dose. 
     
     
         19 . The method of  claim 18 , wherein the total amount of protease in the composition is about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 25,000; about 30,000; about 35,000; about 40,000; about 50,000; about 55,000; about 65,000; about 70,000; about 75,000; about 90,000; about 95,000; about 100,000; about 110,000; about 115,000; about 130,000; about 140,000; about 140,400; about 150,000; about 155,000; about 160,000; about 170,000; about 175,000; about 180,000; about 190,000; about 195,000; about 200,000; about 210,000; about 220,000; about 230,000; about 240,000; about 250,000; about 280,000; about 290,000; about 300,000; about 310,000; about 320,000; about 330,000; about 340,000; about 350,000; about 360,000; about 370,000; about 380,000; about 390,000; about 400,000; about 410,000; about 420,000; about 430,000; about 440,000; about 450,000; about 465,000; about 470,000; about 480,000; about 490,000; about 500,000; about 510,000; about 520,000; about 530,000; about 540,000; about 550,000; about 560,000; about 570,000; about 580,000; about 590,000; about 600,000; about 610,000; about 620,000; about 630,000; about 640,000; about 650,000; about 660,000; about 670,000; about 680,000; about 690,000; about 700,000; about 710,000; about 720,000; about 730,000; about 740,000; about 750,000; about 760,000; about 770,000; about 780,000; about 790,000; about 800,000; about 810,000; about 820,000; about 830,000; about 840,000; about 850,000; about 860,000; about 870,000; about 880,000; about 890,000; about 900,000; about 910,000; about 920,000; about 930,000; about 940,000; about 950,000; about 960,000; about 970,000; about 980,000; about 990,000; about 1,000,000; about 1,010,000; about 1,020,000; about 1,020,000; about 1,030,000; about 1,040,000; about 1,050,000; about 1,060,000; about 1,070,000; about 1,080,000; about 1,090,000; about 1,100,000; about 1,100,000; about 1,120,000; about 1,130,000; about 1,140,000; about 1,150,000; about 1,170,000; about 1,190,000; about 1,200,000; about 1,210,000; about 1,250,000; about 1,300,000; about 1,350,000; about 1,400,000; about 1,450,000; or about 1,500,000; about 1,200,000; about 1,250,000; about 1,300,000; about 1,350,000; about 1,400,000; about 1,450,000; or about 1,500,000 U.S.P. units/dose. 
     
     
         20 . The method of  claim 9 , wherein the total amount of amylase in the composition is from about 1,000 to about 15,000,000; from about 5,000 to about 1,000,000; from about 15,000 to about 750,000; from about 50,000 to about 500,000; from about 75,000 to about 250,000; from about 95,000 to about 200,000; or from about 100,000 to about 150,000 U.S.P. units/dose. 
     
     
         21 . The method of  claim 20 , wherein the total amount of amylase in the composition is about 1,000; about 3,000; about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 25,000; about 30,000; about 35,000; about 40,000; about 50,000; about 65,000; about 70,000; about 75,000; about 100,000; about 140,000; about 144,000; about 210,000; about 280,000; about 350,000; about 420,000; about 490,000; about 500,000; about 560,000; about 630,000; about 700,000; about 770,000; about 840,000; about 910,000; about 980,000; about 1,000,000; about 1,050,000; about 2,000,000; about 3,000,000; about 4,000,000; about 5,000,000; about 6,000,000; about 7,000,000; about 8,000,000; about 9,000,000; about 10,000,000; about 11,000,000; about 12,000,000; about 13,000,000; about 14,000,000; and about 15,000,000 U.S.P. units/dose. 
     
     
         22 . The method of  claim 9 , wherein the total amount of lipase in the composition is from about 1,500 to about 282,000; from about 5,000 to about 200,000; from about 5,000 to about 150,000; from about 75,000 to about 100,000; from about 10,000 to about 75,000; from about 15,000 to about 50,000; or from about 20,000 to about 40,000 U.S.P. units/dose. 
     
     
         23 . The method of  claim 22 , wherein the total amount of lipase is about 1,500; about 1,880; about 2,000; about 3,000; about 5,000; about 7,500; about 8,400; about 10,000; about 15,000; about 16,800; about 20,000; about 23,000; about 23,040; about 25,000; about 30,000; about 33,600; about 40,000; about 50,000; about 50,400; about 65,000; about 67,200; about 75,000; about 84,000; about 100,000; about 100,800; about 117,600; about 125,000; about 134,400; about 150,000; about 151,200; about 168,000; about 184,800; about 200,000; about 201,600; about 218,400; about 235,200; about 250,000; about 252,000; and about 282,000 U.S.P. units/dose. 
     
     
         24 . The method of  claim 1 , wherein the pharmaceutical composition comprises about 23,000 U.S.P. units/dose of lipase, about 144,000 U.S.P. units/dose of amylase and about 140,000 U.S.P. units/dose of protease. 
     
     
         25 . The method of  claim 1 , wherein the pharmaceutical composition comprises about 23,040 U.S.P. units/dose of lipase, about 144,000 U.S.P. units/dose of amylase and about 140,400 U.S.P. units/dose of protease. 
     
     
         26 . The method of  claim 1 , wherein the pharmaceutical composition comprises about 16,800 U.S.P. units/dose of lipase, about 70,000 U.S.P. units/dose of protease, and about 70,000 U.S.P. units/dose of amylase. 
     
     
         27 . The method of  claim 1 , wherein the pharmaceutical composition comprises about 16,800 U.S.P. units/dose of lipase, about 110,000 U.S.P. units/dose of protease, and about 70,000 U.S.P. units/dose of amylase. 
     
     
         28 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 8,400 U.S.P. units lipase, 35,000 U.S.P. units protease, and about 35,000 U.S.P. units amylase. 
     
     
         29 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 16,800 U.S.P. units lipase, about 70,000 U.S.P. units protease, and about 70,000 U.S.P. units amylase. 
     
     
         30 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 33,600 U.S.P. units lipase, about 140,000 U.S.P. units protease, and about 140,000 U.S.P. units amylase. 
     
     
         31 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 50,400 U.S.P. units lipase, about 210,000 U.S.P. units protease, and about 210,000 U.S.P. units amylase. 
     
     
         32 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 67,200 U.S.P. units lipase, about 280,000 U.S.P. units protease, and about 280,000 U.S.P. units amylase. 
     
     
         33 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 84,000 U.S.P. units lipase, about 350,000 U.S.P. units protease, and about 350,000 U.S.P. units amylase. 
     
     
         34 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 100,800 U.S.P. units lipase, about 420,000 U.S.P. units protease, and about 420,000 U.S.P. units amylase. 
     
     
         35 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 117,600 U.S.P. units lipase, about 490,000 U.S.P. units protease, and about 490,000 U.S.P. units amylase. 
     
     
         36 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 134,400 U.S.P. units lipase, about 560,000 U.S.P. units protease, and about 560,000 U.S.P. units amylase. 
     
     
         37 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 151,200 U.S.P. units lipase, about 630,000 U.S.P. units protease, and about 630,000 U.S.P. units amylase. 
     
     
         38 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 168,000 U.S.P. units lipase, about 700,000 U.S.P. units protease, and about 700,000 U.S.P. units amylase. 
     
     
         39 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 184,800 U.S.P. units lipase, about 770,000 U.S.P. units protease, and about 770,000 U.S.P. units amylase. 
     
     
         40 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 201,600 U.S.P. units lipase, about 840,000 U.S.P. units protease, and about 840,000 U.S.P. units amylase. 
     
     
         41 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 218,400 U.S.P. units lipase, about 910,000 U.S.P. units protease, and about 910,000 U.S.P. units amylase. 
     
     
         42 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 235,200 U.S.P. units lipase, about 980,000 U.S.P. units protease, and about 980,000 U.S.P. units amylase. 
     
     
         43 . The method of  claim 9 , wherein the pharmaceutical composition comprises about 252,000 U.S.P. units lipase, about 1,050,000 U.S.P. units protease, and about 1,050,000 U.S.P. units amylase. 
     
     
         44 . The method of any one of  claims 28 - 43 , further comprising a supplemental amount of protease selected from the group consisting of about 0 U.S.P. units; about 20,000 U.S.P. units; about 40,000 U.S.P. units; about 60,000 U.S.P. units; about 80,000 U.S.P. units; about 100,000 U.S.P. units; about 120,000 U.S.P. units; about 140,000 U.S.P. units; and about 160,000 U.S.P. units protease. 
     
     
         45 . The method of  claim 1 , wherein the treatment increases weight gain of the individual. 
     
     
         46 . A pharmaceutical composition comprising a therapeutically effective amount of digestive enzymes for use in the prevention or treatment of Celiac disease. 
     
     
         47 . The pharmaceutical composition of  claim 46 , wherein administration of the composition to a subject partially or fully resolves one or more symptoms of Celiac disease. 
     
     
         48 . The pharmaceutical composition of  claim 47 , wherein the one or more symptoms are selected from the group consisting of abdominal pain, bloating, gas, or indigestion, constipation, decreased appetite, diarrhea, lactose intolerance, nausea and vomiting, unexplained weight loss, bruising easily, depression, anxiety, chronic headaches, migraines, fatigue, growth delay in children, hair loss, itchy skin, missed menstrual periods, mouth ulcers, muscle cramps and joint pain, nosebleeds, seizures, tingling or numbness in the hands or feet, unexplained short height, defects in the tooth enamel and changes in tooth color, delayed puberty, irritable and fussy behavior, poor weight gain, slowed growth and shorter than normal height, or a combination thereof. 
     
     
         49 . The pharmaceutical composition of  claim 46 , wherein the composition comprising digestive enzymes comprises amylases, lipases, proteases, or a combination thereof. 
     
     
         50 . The pharmaceutical composition of  claim 49 , wherein the composition further comprises chymotrypsin, trypsin, pancreatin, papain, or a combination thereof. 
     
     
         51 . The pharmaceutical composition of  claim 49 , wherein the digestive enzymes are derived from a source selected from the group consisting of animal enzymes, plant enzymes, synthetic enzymes, and a combination thereof. 
     
     
         52 . The pharmaceutical composition of  claim 51 , wherein the animal enzyme is derived from a mammal. 
     
     
         53 . The pharmaceutical composition of  claim 52 , wherein the mammal is a pig. 
     
     
         54 . The pharmaceutical composition of  claim 51 , wherein the animal enzyme is derived from a pancreas. 
     
     
         55 . The pharmaceutical composition of  claim 46 , wherein the compositions comprising digestive enzymes are manufactured using a technology selected from the group consisting of enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation, and a combination thereof. 
     
     
         56 . The pharmaceutical composition of  claim 46 , wherein the composition is formulated for oral administration. 
     
     
         57 . The pharmaceutical composition of  claim 46 , wherein the composition is a dosage formulation selected from the group consisting of pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, suppository and a combination thereof. 
     
     
         58 . The pharmaceutical composition of  claim 49 , wherein the total amount of protease in the composition is from about 10,000 to about 1,500,000; from about 25,000 to about 1,000,000; from about 50,000 to about 750,000; from about 75,000 to about 500,000; from about 85,000 to about 250,000; from about 95,000 to about 200,000; or from about 110,000 to about 150,000 U.S.P. units/dose. 
     
     
         59 . The pharmaceutical composition of  claim 58 , wherein the total amount of protease in the composition is about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 25,000; about 30,000; about 35,000; about 40,000; about 50,000; about 55,000; about 65,000; about 70,000; about 75,000; about 90,000; about 95,000; about 100,000; about 110,000; about 115,000; about 130,000; about 140,000; about 140,400; about 150,000; about 155,000; about 160,000; about 170,000; about 175,000; about 180,000; about 190,000; about 195,000; about 200,000; about 210,000; about 220,000; about 230,000; about 240,000; about 250,000; about 280,000; about 290,000; about 300,000; about 310,000; about 320,000; about 330,000; about 340,000; about 350,000; about 360,000; about 370,000; about 380,000; about 390,000; about 400,000; about 410,000; about 420,000; about 430,000; about 440,000; about 450,000; about 465,000; about 470,000; about 480,000; about 490,000; about 500,000; about 510,000; about 520,000; about 530,000; about 540,000; about 550,000; about 560,000; about 570,000; about 580,000; about 590,000; about 600,000; about 610,000; about 620,000; about 630,000; about 640,000; about 650,000; about 660,000; about 670,000; about 680,000; about 690,000; about 700,000; about 710,000; about 720,000; about 730,000; about 740,000; about 750,000; about 760,000; about 770,000; about 780,000; about 790,000; about 800,000; about 810,000; about 820,000; about 830,000; about 840,000; about 850,000; about 860,000; about 870,000; about 880,000; about 890,000; about 900,000; about 910,000; about 920,000; about 930,000; about 940,000; about 950,000; about 960,000; about 970,000; about 980,000; about 990,000; about 1,000,000; about 1,010,000; about 1,020,000; about 1,020,000; about 1,030,000; about 1,040,000; about 1,050,000; about 1,060,000; about 1,070,000; about 1,080,000; about 1,090,000; about 1,100,000; about 1,100,000; about 1,120,000; about 1,130,000; about 1,140,000; about 1,150,000; about 1,170,000; about 1,190,000; about 1,200,000; about 1,210,000; about 1,250,000; about 1,300,000; about 1,350,000; about 1,400,000; about 1,450,000; or about 1,500,000; about 1,200,000; about 1,250,000; about 1,300,000; about 1,350,000; about 1,400,000; about 1,450,000; or about 1,500,000 U.S.P. units/dose. 
     
     
         60 . The pharmaceutical composition of  claim 49 , wherein the total amount of amylase in the composition is from about 1,000 to about 15,000,000; from about 5,000 to about 1,000,000; from about 15,000 to about 750,000; from about 50,000 to about 500,000; from about 75,000 to about 250,000; from about 95,000 to about 200,000; or from about 100,000 to about 150,000 U.S.P. units/dose. 
     
     
         61 . The pharmaceutical composition of  claim 60 , wherein the total amount of amylase in the composition is about 1,000; about 3,000; about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 25,000; about 30,000; about 35,000; about 40,000; about 50,000; about 65,000; about 70,000; about 75,000; about 100,000; about 140,000; about 144,000; about 210,000; about 280,000; about 350,000; about 420,000; about 490,000; about 500,000; about 560,000; about 630,000; about 700,000; about 770,000; about 840,000; about 910,000; about 980,000; about 1,000,000; about 1,050,000; about 2,000,000; about 3,000,000; about 4,000,000; about 5,000,000; about 6,000,000; about 7,000,000; about 8,000,000; about 9,000,000; about 10,000,000; about 11,000,000; about 12,000,000; about 13,000,000; about 14,000,000; and about 15,000,000 U.S.P. units/dose. 
     
     
         62 . The pharmaceutical composition of  claim 49 , wherein the total amount of lipase in the composition is from about 1,500 to about 282,000; from about 5,000 to about 200,000; from about 5,000 to about 150,000; from about 75,000 to about 100,000; from about 10,000 to about 75,000; from about 15,000 to about 50,000; or from about 20,000 to about 40,000 U.S.P. units/dose. 
     
     
         63 . The pharmaceutical composition of  claim 62 , wherein the total amount of lipase in the composition is about 1,500; about 1,880; about 2,000; about 3,000; about 5,000; about 7,500; about 8,400; about 10,000; about 15,000; about 16,800; about 20,000; about 23,000; about 23,040; about 25,000; about 30,000; about 33,600; about 40,000; about 50,000; about 50,400; about 65,000; about 67,200; about 75,000; about 84,000; about 100,000; about 100,800; about 117,600; about 125,000; about 134,400; about 150,000; about 151,200; about 168,000; about 184,800; about 200,000; about 201,600; about 218,400; about 235,200; about 250,000; about 252,000; and about 282,000 U.S.P. units/dose. 
     
     
         64 . A pharmaceutical composition comprising digestive enzymes, wherein the pharmaceutical composition comprises about 23,000 U.S.P. units/dose of lipase, about 144,000 U.S.P. units/dose of amylase and about 140,000 U.S.P. units/dose of protease. 
     
     
         65 . A pharmaceutical composition comprising digestive enzymes, wherein the pharmaceutical composition comprises about 23,040 U.S.P. units/dose of lipase, about 144,000 U.S.P. units/dose of amylase and about 140,400 U.S.P. units/dose of protease. 
     
     
         66 . A pharmaceutical composition comprising digestive enzymes, wherein the digestive enzymes comprise about 16,800 U.S.P. units/dose of lipase, about 70,000 U.S.P. units/dose of protease, and about 70,000 U.S.P. units/dose of amylase. 
     
     
         67 . A pharmaceutical composition comprising digestive enzymes, wherein the digestive enzymes comprise about 16,800 U.S.P. units/dose of lipase, about 110,000 U.S.P. units/dose of protease, and about 70,000 U.S.P. units/dose of amylase. 
     
     
         68 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 8,400 U.S.P. units lipase, 35,000 U.S.P. units protease, and about 35,000 U.S.P. units amylase. 
     
     
         69 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 16,800 U.S.P. units lipase, about 70,000 U.S.P. units protease, and about 70,000 U.S.P. units amylase. 
     
     
         70 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 33,600 U.S.P. units lipase, about 140,000 U.S.P. units protease, and about 140,000 U.S.P. units amylase. 
     
     
         71 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 50,400 U.S.P. units lipase, about 210,000 U.S.P. units protease, and about 210,000 U.S.P. units amylase. 
     
     
         72 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 67,200 U.S.P. units lipase, about 280,000 U.S.P. units protease, and about 280,000 U.S.P. units amylase. 
     
     
         73 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 84,000 U.S.P. units lipase, about 350,000 U.S.P. units protease, and about 350,000 U.S.P. units amylase. 
     
     
         74 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 100,800 U.S.P. units lipase, about 420,000 U.S.P. units protease, and about 420,000 U.S.P. units amylase. 
     
     
         75 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 117,600 U.S.P. units lipase, about 490,000 U.S.P. units protease, and about 490,000 U.S.P. units amylase. 
     
     
         76 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 134,400 U.S.P. units lipase, about 560,000 U.S.P. units protease, and about 560,000 U.S.P. units amylase. 
     
     
         77 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 151,200 U.S.P. units lipase, about 630,000 U.S.P. units protease, and about 630,000 U.S.P. units amylase. 
     
     
         78 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 168,000 U.S.P. units lipase, about 700,000 U.S.P. units protease, and about 700,000 U.S.P. units amylase. 
     
     
         79 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 184,800 U.S.P. units lipase, about 770,000 U.S.P. units protease, and about 770,000 U.S.P. units amylase. 
     
     
         80 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 201,600 U.S.P. units lipase, about 840,000 U.S.P. units protease, and about 840,000 U.S.P. units amylase. 
     
     
         81 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 218,400 U.S.P. units lipase, about 910,000 U.S.P. units protease, and about 910,000 U.S.P. units amylase. 
     
     
         82 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 235,200 U.S.P. units lipase, about 980,000 U.S.P. units protease, and about 980,000 U.S.P. units amylase. 
     
     
         83 . A dose of a pharmaceutical composition comprising digestive enzymes, wherein the dose comprises about 252,000 U.S.P. units lipase, about 1,050,000 U.S.P. units protease, and about 1,050,000 U.S.P. units amylase. 
     
     
         84 . A dose of any one of  claims 64 - 83 , further comprising a supplemental amount of protease selected from the group consisting of about 0 U.S.P. units; about 20,000 U.S.P. units; about 40,000 U.S.P. units; about 60,000 U.S.P. units; about 80,000 U.S.P. units; about 100,000 U.S.P. units; about 120,000 U.S.P. units; about 140,000 U.S.P. units; and about 160,000 U.S.P. units protease. 
     
     
         85 . A method of inducing weight gain in a subject, comprising administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of digestive enzymes to the subject. 
     
     
         86 . The method of  claim 85 , wherein the composition is administered 1, 2, 3 or 4 times a day until the subject begins gaining weight. 
     
     
         87 . The method of  claim 85 , wherein the composition is administered 1, 2, 3 or 4 times a week until the subject begins gaining weight. 
     
     
         88 . The method of  claim 85 , wherein the method further comprises modifying the diet of the subject. 
     
     
         89 . The method of  claim 88 , wherein the diet is a gluten-free diet. 
     
     
         90 . The method of  claim 85 , wherein the composition comprising digestive enzymes comprises amylases, lipases, proteases, or a combination thereof. 
     
     
         91 . The method of  claim 90 , wherein the composition further comprises chymotrypsin, trypsin, pancreatin, papain, or a combination thereof. 
     
     
         92 . The method of  claim 85 , wherein the digestive enzymes are derived from a source selected from the group consisting of animal enzymes, plant enzymes, synthetic enzymes, and a combination thereof. 
     
     
         93 . The method of  claim 92 , wherein the animal enzyme is derived from a mammal. 
     
     
         94 . The method of  claim 93 , wherein the mammal is a pig. 
     
     
         95 . The method of  claim 92 , wherein the animal enzyme is derived from a pancreas. 
     
     
         96 . The method of  claim 85 , wherein the compositions comprising digestive enzymes are manufactured using a technology selected from the group consisting of enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation, and a combination thereof. 
     
     
         97 . The method of  claim 85 , wherein the composition is administered orally. 
     
     
         98 . The method of  claim 85 , wherein the composition is a dosage formulation selected from the group consisting of pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, suppository and a combination thereof. 
     
     
         99 . The method of  claim 90 , wherein the total amount of protease in the composition is from about 10,000 to about 1,500,000; from about 25,000 to about 1,000,000; from about 50,000 to about 750,000; from about 75,000 to about 500,000; from about 85,000 to about 250,000; from about 95,000 to about 200,000; or from about 110,000 to about 150,000 U.S.P. units/dose. 
     
     
         100 . The method of  claim 99 , wherein the total amount of protease in the composition is about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 25,000; about 30,000; about 35,000; about 40,000; about 50,000; about 55,000; about 65,000; about 70,000; about 75,000; about 90,000; about 95,000; about 100,000; about 110,000; about 115,000; about 130,000; about 140,000; about 140,400; about 150,000; about 155,000; about 160,000; about 170,000; about 175,000; about 180,000; about 190,000; about 195,000; about 200,000; about 210,000; about 220,000; about 230,000; about 240,000; about 250,000; about 280,000; about 290,000; about 300,000; about 310,000; about 320,000; about 330,000; about 340,000; about 350,000; about 360,000; about 370,000; about 380,000; about 390,000; about 400,000; about 410,000; about 420,000; about 430,000; about 440,000; about 450,000; about 465,000; about 470,000; about 480,000; about 490,000; about 500,000; about 510,000; about 520,000; about 530,000; about 540,000; about 550,000; about 560,000; about 570,000; about 580,000; about 590,000; about 600,000; about 610,000; about 620,000; about 630,000; about 640,000; about 650,000; about 660,000; about 670,000; about 680,000; about 690,000; about 700,000; about 710,000; about 720,000; about 730,000; about 740,000; about 750,000; about 760,000; about 770,000; about 780,000; about 790,000; about 800,000; about 810,000; about 820,000; about 830,000; about 840,000; about 850,000; about 860,000; about 870,000; about 880,000; about 890,000; about 900,000; about 910,000; about 920,000; about 930,000; about 940,000; about 950,000; about 960,000; about 970,000; about 980,000; about 990,000; about 1,000,000; about 1,010,000; about 1,020,000; about 1,020,000; about 1,030,000; about 1,040,000; about 1,050,000; about 1,060,000; about 1,070,000; about 1,080,000; about 1,090,000; about 1,100,000; about 1,100,000; about 1,120,000; about 1,130,000; about 1,140,000; about 1,150,000; about 1,170,000; about 1,190,000; about 1,200,000; about 1,210,000; about 1,250,000; about 1,300,000; about 1,350,000; about 1,400,000; about 1,450,000; or about 1,500,000; about 1,200,000; about 1,250,000; about 1,300,000; about 1,350,000; about 1,400,000; about 1,450,000; or about 1,500,000 U.S.P. units/dose. 
     
     
         101 . The method of  claim 90 , wherein the total amount of amylase in the composition is from about 1,000 to about 15,000,000; from about 5,000 to about 1,000,000; from about 15,000 to about 750,000; from about 50,000 to about 500,000; from about 75,000 to about 250,000; from about 95,000 to about 200,000; or from about 100,000 to about 150,000 U.S.P. units/dose. 
     
     
         102 . The method of  claim 101 , wherein the total amount of amylase in the composition is about 1,000; about 3,000; about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 25,000; about 30,000; about 35,000; about 40,000; about 50,000; about 65,000; about 70,000; about 75,000; about 100,000; about 140,000; about 144,000; about 210,000; about 280,000; about 350,000; about 420,000; about 490,000; about 500,000; about 560,000; about 630,000; about 700,000; about 770,000; about 840,000; about 910,000; about 980,000; about 1,000,000; about 1,050,000; about 2,000,000; about 3,000,000; about 4,000,000; about 5,000,000; about 6,000,000; about 7,000,000; about 8,000,000; about 9,000,000; about 10,000,000; about 11,000,000; about 12,000,000; about 13,000,000; about 14,000,000; and about 15,000,000 U.S.P. units/dose. 
     
     
         103 . The method of  claim 90 , wherein the total amount of lipase in the composition is from about 1,500 to about 282,000; from about 5,000 to about 200,000; from about 5,000 to about 150,000; from about 75,000 to about 100,000; from about 10,000 to about 75,000; from about 15,000 to about 50,000; or from about 20,000 to about 40,000 U.S.P. units/dose. 
     
     
         104 . The method of  claim 103 , wherein the total amount of lipase in the composition is about 1,500; about 1,880; about 2,000; about 3,000; about 5,000; about 7,500; about 8,400; about 10,000; about 15,000; about 16,800; about 20,000; about 23,000; about 23,040; about 25,000; about 30,000; about 33,600; about 40,000; about 50,000; about 50,400; about 65,000; about 67,200; about 75,000; about 84,000; about 100,000; about 100,800; about 117,600; about 125,000; about 134,400; about 150,000; about 151,200; about 168,000; about 184,800; about 200,000; about 201,600; about 218,400; about 235,200; about 250,000; about 252,000; and about 282,000 U.S.P. units/dose. 
     
     
         105 . The method of  claim 85 , wherein the subject has Celiac disease. 
     
     
         106 . The method of  claim 85 , wherein the pharmaceutical composition comprises about 23,000 U.S.P. units/dose of lipase, about 144,000 U.S.P. units/dose of amylase and about 140,000 U.S.P. units/dose of protease. 
     
     
         107 . The method of  claim 85 , wherein the pharmaceutical composition comprises about 23,040 U.S.P. units/dose of lipase, about 144,000 U.S.P. units/dose of amylase and about 140,400 U.S.P. units/dose of protease. 
     
     
         108 . The method of  claim 85 , wherein the pharmaceutical composition comprises digestive enzymes, wherein the digestive enzymes comprise about 16,800 U.S.P. units/dose of lipase, about 70,000 U.S.P. units/dose of protease, and about 70,000 U.S.P. units/dose of amylase. 
     
     
         109 . The method of  claim 85 , wherein the pharmaceutical composition comprises digestive enzymes, wherein the digestive enzymes comprise about 16,800 U.S.P. units/dose of lipase, about 110,000 U.S.P. units/dose of protease, and about 70,000 U.S.P. units/dose of amylase. 
     
     
         110 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 8,400 U.S.P. units lipase, 35,000 U.S.P. units protease, and about 35,000 U.S.P. units amylase. 
     
     
         111 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 16,800 U.S.P. units lipase, about 70,000 U.S.P. units protease, and about 70,000 U.S.P. units amylase. 
     
     
         112 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 33,600 U.S.P. units lipase, about 140,000 U.S.P. units protease, and about 140,000 U.S.P. units amylase. 
     
     
         113 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 50,400 U.S.P. units lipase, about 210,000 U.S.P. units protease, and about 210,000 U.S.P. units amylase. 
     
     
         114 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 67,200 U.S.P. units lipase, about 280,000 U.S.P. units protease, and about 280,000 U.S.P. units amylase. 
     
     
         115 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 84,000 U.S.P. units lipase, about 350,000 U.S.P. units protease, and about 350,000 U.S.P. units amylase. 
     
     
         116 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 100,800 U.S.P. units lipase, about 420,000 U.S.P. units protease, and about 420,000 U.S.P. units amylase. 
     
     
         117 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 117,600 U.S.P. units lipase, about 490,000 U.S.P. units protease, and about 490,000 U.S.P. units amylase. 
     
     
         118 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 134,400 U.S.P. units lipase, about 560,000 U.S.P. units protease, and about 560,000 U.S.P. units amylase. 
     
     
         119 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 151,200 U.S.P. units lipase, about 630,000 U.S.P. units protease, and about 630,000 U.S.P. units amylase. 
     
     
         120 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 168,000 U.S.P. units lipase, about 700,000 U.S.P. units protease, and about 700,000 U.S.P. units amylase. 
     
     
         121 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 184,800 U.S.P. units lipase, about 770,000 U.S.P. units protease, and about 770,000 U.S.P. units amylase. 
     
     
         122 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 201,600 U.S.P. units lipase, about 840,000 U.S.P. units protease, and about 840,000 U.S.P. units amylase. 
     
     
         123 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 218,400 U.S.P. units lipase, about 910,000 U.S.P. units protease, and about 910,000 U.S.P. units amylase. 
     
     
         124 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 235,200 U.S.P. units lipase, about 980,000 U.S.P. units protease, and about 980,000 U.S.P. units amylase. 
     
     
         125 . The method of  claim 90 , wherein the pharmaceutical composition comprises about 252,000 U.S.P. units lipase, about 1,050,000 U.S.P. units protease, and about 1,050,000 U.S.P. units amylase. 
     
     
         126 . The method of any one of  claims 110 - 125 , further comprising a supplemental amount of protease selected from the group consisting of about 0 U.S.P. units; about 20,000 U.S.P. units; about 40,000 U.S.P. units; about 60,000 U.S.P. units; about 80,000 U.S.P. units; about 100,000 U.S.P. units; about 120,000 U.S.P. units; about 140,000 U.S.P. units; and about 160,000 U.S.P. units protease.