Prebiotic Formulations and Methods of Use

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.

What is claimed is: 
     
         1 . A method of treating lactose intolerance in a subject experiencing one or more symptoms of lactose intolerance comprising administering a pharmaceutical composition to said subject, wherein at least about 95% of said pharmaceutical composition is GOS, wherein said subject is administered between 1.5 and 15 g of said pharmaceutical composition per day. 
     
     
         2 . The method of  claim 1 , wherein said composition is provided in a dosing unit. 
     
     
         3 . The method of  claim 2 , wherein said dosing unit is a capsule, tablet, softgel, ephervescant tablet, or lozenge. 
     
     
         4 . The method of  claim 2 , wherein said dosing unit further comprises an enteric coating. 
     
     
         5 . The method of  claim 1 , wherein said composition does not comprise a probiotic. 
     
     
         6 . The method of  claim 1 , wherein said subject is a human subject. 
     
     
         7 . The method of  claim 6 , wherein said subject is a pediatric subject, an adult subject, an elderly subject, or a post-menopausal woman. 
     
     
         8 . The method of  claim 1 , wherein said subject has a calcium deficiency. 
     
     
         9 . The method of  claim 1 , wherein said prebiotic composition is administered each day for a predetermined number of days. 
     
     
         10 . The method of  claim 9 , wherein said predetermined number of days is 14, 30, or 35 days. 
     
     
         11 . The method of  claim 9 , wherein said method comprises administering a lower dosage of GOS on the first day of administration than the last day of administration. 
     
     
         12 . The method of  claim 9 , wherein said method comprises administering the same dosage of GOS on the first day of administration as on the last day of administration. 
     
     
         13 . The method of  claim 1 , wherein said one or more symptoms comprise flatulence, heartburn, upset stomach, nausea, bloating, diarrhea, abdominal pain, cramping, or vomiting. 
     
     
         14 . A pharmaceutically acceptable oral dosage form of GOS comprising one or more dosing units, each of said dosing units comprising 0.1 to 2 g of a GOS composition wherein said GOS composition is a liquid encapsulated in a gelatin capsule. 
     
     
         15 . The pharmaceutically acceptable oral dosage form of  claim 14 , wherein said gelatin capsule is size 000, 00, 0, 1, 2, 3, 4, or 5. 
     
     
         16 . The pharmaceutically acceptable oral dosage form of  claim 14 , wherein said GOS composition comprises at least about 80% GOS by weight. 
     
     
         17 . The pharmaceutically acceptable oral dosage form of  claim 14 , wherein said GOS composition comprises at least about 95% GOS by weight. 
     
     
         18 . The pharmaceutically acceptable oral dosage form of  claim 14 , wherein said GOS composition does not comprise a probiotic. 
     
     
         19 . The oral dosage form of  claim 14 , wherein said gelatin capsule further comprises an enteric coating. 
     
     
         20 . A method of treating lactose intolerance in a subject experiencing one or more symptoms of lactose intolerance comprising:
 a. administering a hydrogen breath test (HBT) to said subject;   b. diagnosing said subject as having or not having lactose intolerance based upon a HBT result; and,   c. administering a prebiotic composition to said subject diagnosed as having lactose intolerance based upon said HBT results, wherein said prebiotic composition comprises GOS.   
     
     
         21 . The method of  claim 20 , wherein said HBT result is an increase in breath hydrogen of greater than 12 ppm. 
     
     
         22 . The method of  claim 20 , wherein said HBT result is an increase in breath hydrogen of greater than 15 ppm. 
     
     
         23 . The method of  claim 20 , wherein said HBT result is an increase in breath hydrogen of greater than 20 ppm. 
     
     
         24 . The method of  claim 20 , further comprising administering a lactose intolerance diagnostic questionnaire to said subject and diagnosing said subject as having or not having lactose intolerance based upon said HBT result and a lactose intolerance diagnostic questionnaire result. 
     
     
         25 . The method of  claim 20  wherein at least about 95% of the total weight of said composition is GOS. 
     
     
         26 . The method of  claim 20 , wherein said composition does not comprise a probiotic. 
     
     
         27 . The method of  claim 20 , wherein said composition is provided in a dosing unit. 
     
     
         28 . The method of  claim 20 , wherein said subject is a human subject. 
     
     
         29 . The method of  claim 20 , wherein said subject has a calcium deficiency. 
     
     
         30 . The method of  claim 20 , wherein said prebiotic composition is administered each day for a predetermined number of days. 
     
     
         31 . The method of  claim 20 , wherein said predetermined number of days is 14, 30, or 35 days. 
     
     
         32 . The method of  claim 20 , wherein said one or more symptoms comprise flatulence, heartburn, upset stomach, nausea, bloating, diarrhea, abdominal pain, cramping, or vomiting.