Prebiotic Formulations and Methods of Use

Abstract

The invention provides methods and compositions for treating symptoms associated with lactose intolerance and for overall improvement in gastrointestinal health. Described herein are methods and compositions for improving overall gastrointestinal health or for decreasing symptoms of lactose intolerance by administering to subject in need thereof a prebiotic composition, optionally in combination with effective amount of a probiotic microbe or microbes.

1 - 31 . (canceled) 
     
     
         32 . An oral dosage form comprising a prebiotic composition and an excipient, wherein the prebiotic composition comprises 50% or more galactooligosaccharides (GOS) by weight and less than 9% digestible saccharides by weight. 
     
     
         33 . The oral dosage form of  claim 32 , wherein the prebiotic composition comprises 60%, 70%, 80%, 85%, 90%, or more GOS by weight. 
     
     
         34 . The oral dosage form of  claim 32 , wherein the prebiotic composition comprises 95% or more GOS by weight. 
     
     
         35 . The oral dosage form of  claim 32 , wherein the dosage form is a solid dosage form. 
     
     
         36 . The oral dosage form of  claim 32 , wherein the dosage form is a gel dosage form. 
     
     
         37 . The oral dosage form of  claim 32 , formulated for controlled release. 
     
     
         38 . The oral dosage form of  claim 32 , further comprising an enteric coating. 
     
     
         39 . The oral dosage form of  claim 32 , provided as a capsule, tablet, softgel, powder, effervescent form, chewable formulation, or lozenge. 
     
     
         40 . The oral dosage form of  claim 32 , wherein the prebiotic composition comprises less than 8%, 7%, or 6% digestible saccharides by weight. 
     
     
         41 . The oral dosage form of  claim 32 , wherein the prebiotic composition comprises less than 5% digestible saccharides by weight. 
     
     
         42 . The oral dosage form of  claim 32 , wherein the digestible saccharides comprise lactose, galactose, or glucose. 
     
     
         43 . The oral dosage form of  claim 32 , wherein the prebiotic composition comprises about 0.001% to about 1% glucose. 
     
     
         44 . The oral dosage form of  claim 32 , wherein the prebiotic composition comprises about 0.01% to about 0.1% glucose. 
     
     
         45 . The oral dosage form of  claim 32 , wherein the prebiotic composition comprises about 0.1% galactose to about 2% galactose. 
     
     
         46 . The oral dosage form of  claim 32 , wherein the prebiotic composition comprises less than 2% lactose. 
     
     
         47 . The oral dosage form of  claim 32 , wherein the GOS comprises about 45-55% by weight trisaccharides. 
     
     
         48 . The oral dosage form of  claim 32 , wherein the GOS comprises about 15-25% by weight tetrasaccharides. 
     
     
         49 . The oral dosage form of  claim 32 , wherein the GOS comprises about 1-10% by weight pentasaccharides. 
     
     
         50 . The oral dosage form of  claim 32 , wherein the GOS comprises about 45-55% by weight trisaccharides, about 15-25% by weight tetrasaccharides, and about 1-10% by weight pentasaccharides. 
     
     
         51 . The oral dosage form of  claim 32 , wherein the prebiotic composition comprises less than about 10 ppm heavy metals. 
     
     
         52 . The oral dosage form of  claim 32 , wherein the prebiotic composition comprises less than about 0.10% by weight sulphated ash. 
     
     
         53 . The oral dosage form of  claim 32 , comprising about 1 mg to about 20 g of the prebiotic composition. 
     
     
         54 . The oral dosage form of  claim 32 , wherein the excipient is silicone dioxide or microcrystalline cellulose. 
     
     
         55 . The oral dosage form of  claim 54 , wherein the microcrystalline cellulose is silicified microcrystalline cellulose. 
     
     
         56 . The oral dosage form of  claim 32 , further comprising a flavoring and/or colorant. 
     
     
         57 . The oral dosage form of  claim 32 , wherein the dosage form does not comprise a probiotic. 
     
     
         58 . A powder comprising a prebiotic composition and an excipient, wherein the prebiotic composition comprises 95% or more GOS by weight and less than 5% digestible saccharides by weight. 
     
     
         59 . A sachet comprising a powder, wherein the powder comprises a prebiotic composition, and wherein the prebiotic composition comprises 50% or more GOS by weight and less than 9% digestible saccharides by weight. 
     
     
         60 . The sachet of  claim 59 , further comprising an excipient. 
     
     
         61 . The sachet of  claim 59 , comprising about 1 mg to about 20 g of the prebiotic composition. 
     
     
         62 . The sachet of  claim 59 , wherein the excipient is silicone dioxide or microcrystalline cellulose. 
     
     
         63 . The sachet of  claim 62 , wherein the microcrystalline cellulose is silicified microcrystalline cellulose. 
     
     
         64 . The sachet of  claim 59 , further comprising a flavoring and/or colorant. 
     
     
         65 . The sachet of  claim 59 , wherein the sachet does not comprise a probiotic. 
     
     
         66 . A sachet comprising a powder comprising an excipient and a prebiotic composition, wherein the prebiotic composition comprises 95% or more GOS by weight and less than 5% digestible saccharides by weight.