Glycan therapeutic compositions and related methods thereof

Abstract

Preparations of glycan therapeutics, pharmaceutical compositions, dietary supplements and medical foods thereof are provided, and methods of using said gycan therapeutics, e.g. in cancer therapy.

1 . A pharmaceutical composition, medical food, or dietary supplement for use in treating an immune imbalance in a human subject comprising a glycan therapeutic preparation in an effective amount to treat the subject. 
     
     
         2 . The composition of  claim 1 , wherein the pharmaceutical composition, medical food, or dietary supplement is administered in combination with a second agent or therapy. 
     
     
         3 . The composition of any one of  claims 2 - 3 , wherein the pharmaceutical composition, medical food, or dietary supplement is administered simultaneously with a second agent or therapy. 
     
     
         4 . The composition of any one of  claims 2 - 3 , wherein the second agent is a dietary fiber or probiotic bacterium. 
     
     
         5 . The composition of any one of  claims 2 - 3 , wherein the combination is administered to a subject that has been previously treated for an immune imbalance. 
     
     
         6 . The composition of any one of  claims 2 - 3 , wherein the combination is administered to a subject that has been previously not been treated for an immune imbalance. 
     
     
         7 . A pharmaceutical composition for use in reducing an infection and/or an inflammation in a subject having an immune imbalance, wherein the composition comprises an effective amount of a glycan therapeutic preparation to reduce the infection and/or inflammation in the subject. 
     
     
         8 . A pharmaceutical composition for use in modulating the composition and/or metabolic activity of the intestinal bacterial community of a subject having an immune imbalance, comprising a glycan therapeutic preparation and an anti- or pro-inflammatory agent in an amount effective to modulate the subject's immune system. 
     
     
         9 . A pharmaceutical composition for use in treating a dysbiosis in a subject having an immune imbalance, wherein the composition comprises an effective amount of a glycan therapeutic preparation to treat the dysbiosis. 
     
     
         10 . The composition of any one of  claims 7 - 9 , wherein the composition further comprises a probiotic microorganism. 
     
     
         11 . The composition of any one of  claims 7 - 9 , wherein the level of a short-chain fatty acid (SCFA) is modulated in a subject upon administration of the composition. 
     
     
         12 . The composition of any one of  claims 7 - 9 , wherein administration of the composition results in the stimulation of growth or stimulation of activity of beneficial gut bacteria, e.g., Bifidobacteria. 
     
     
         13 . The composition of any one of  claims 7 - 9 , wherein administration of the composition results in the modulation of one or more biomarkers comprising Interleukin 10, Interleukin, 4, Interleukin 13, or Interleukin 35. 
     
     
         14 . The composition of any one of  claims 7 - 9 , wherein administration of the composition results in the modulation of one or more biomarkers comprising C-reactive protein, interleukin-6, interleukin-8, interleukin-18, insulin, blood glucose, leptin, serum amyloid A, serum amyloid P, or tumor necrosis factor-alpha. 
     
     
         15 . The composition of any one of  claims 7 - 9 , wherein administration of the composition results in the modulation of one or more cytokines comprising TNF-α, IL-8, monocyte chemoattracting protein 1 (MCP-1), TGF-β, IL-12, IFN-γ, IL-4, or IL-10. 
     
     
         16 . The composition of any one of the preceding claims, wherein the immune imbalance comprises a suppression of the subject's immune system. 
     
     
         17 . The composition of any one of the preceding claims, wherein the immune imbalance is an aberrant activation of the subject's immune system. 
     
     
         18 . The composition of any one of the preceding claims, wherein the subject exhibits deficient immune surveillance. 
     
     
         19 . The composition of any one of the preceding claims, wherein the immune imbalance is chronic or acute. 
     
     
         20 . The composition of any one of the preceding claims, wherein the immune imbalance is local or systemic. 
     
     
         21 . The composition of any one of the preceding claims, wherein the immune imbalance is accompanied by aberrant growth of a pathogenic cell (e.g., an intracellular pathogen, an extracellular pathogen, or a cancerous cell). 
     
     
         22 . The composition of any one of the preceding claims, wherein the subject has a cancer, an inflammatory disease, an autoimmune disease, or an infection (e.g., a pathogenic infection). 
     
     
         23 . The composition of any one of the preceding claims, wherein the subject has a cancer. 
     
     
         24 . The composition of  claim 22 , wherein the inflammatory disease is an inflammatory gastrointestinal disease. 
     
     
         25 . A pharmaceutical composition, a medical food or a dietary supplement for use in treating a nutritional imbalance in a human subject, comprising a glycan therapeutic preparation in an effective amount to treat the subject. 
     
     
         26 . The composition of  claim 25 , wherein the pharmaceutical composition, medical food, or dietary supplement is administered in combination with a second agent or therapy. 
     
     
         27 . The composition of any one of  claims 25 - 26 , wherein the pharmaceutical composition, medical food, or dietary supplement is administered simultaneously with a second agent or therapy. 
     
     
         28 . The composition of any one of  claims 25 - 26 , wherein the second agent is a metabolism modulating agent, a dietary fiber, or a probiotic bacterium 
     
     
         29 . The composition of any one of  claims 25 - 26 , wherein the combination is administered to a subject that has been previously treated for a nutritional imbalance. 
     
     
         30 . The composition of any one of  claims 25 - 26 , wherein the combination is administered to a subject that has been previously not been treated for a nutritional imbalance. 
     
     
         31 . A pharmaceutical composition for use in reducing an inflammation in a subject having a nutritional imbalance, wherein the composition comprises an effective amount of a glycan therapeutic preparation to reduce the inflammation. 
     
     
         32 . A pharmaceutical composition for use in modulating the composition and/or metabolic activity of the intestinal bacterial community of a subject having a nutritional imbalance, comprising a glycan therapeutic preparation and an anti- or pro-inflammatory agent in an amount effective to modulate the subject's immune system. 
     
     
         33 . A pharmaceutical composition for use in treating a dysbiosis in a subject having a nutritional imbalance, wherein the composition comprises an effective amount of a glycan therapeutic preparation to treat the dysbiosis. 
     
     
         34 . The composition of any one of  claims 31 - 33 , wherein the composition further comprises a probiotic microorganism. 
     
     
         35 . The composition of any one of  claims 31 - 33 , wherein the level of a short-chain fatty acid (SCFA) is modulating in a subject upon administration of the composition. 
     
     
         36 . The composition of any one of  claims 31 - 33 , wherein administration of the composition results in the stimulation of growth or stimulation of activity of beneficial gut bacteria, e.g., Bifidobacteria. 
     
     
         37 . The composition of any one of  claims 31 - 33 , wherein administration of the composition results in the modulation of one or more biomarkers comprising Interleukin 10, Interleukin, 4, Interleukin 13, or Interleukin 35. 
     
     
         38 . The composition of any one of  claims 31 - 33 , wherein administration of the composition results in the modulation of one or more biomarkers comprising C-reactive protein, interleukin-6, interleukin-8, interleukin-18, insulin, blood glucose, leptin, serum amyloid A, serum amyloid P, or tumor necrosis factor-alpha. 
     
     
         39 . The composition of any one of  claims 31 - 33 , wherein administration of the composition results in the modulation of one or more cytokines comprising TNF-α, IL-8, monocyte chemoattracting protein 1 (MCP-1), TGF-β, IL-12, IFN-γ, IL-4, or IL-10. 
     
     
         40 . The composition of any one of  claims 31 - 39 , wherein the nutritional imbalance is chronic or acute. 
     
     
         41 . The composition of any one of the  claims 31 - 40 , wherein the nutritional imbalance is local or systemic. 
     
     
         42 . The composition of any one of  claims 31 - 41 , wherein the subject has a metabolic disease or syndrome, a wasting syndrome, or cancer. 
     
     
         43 . The composition of any one of  claims 31 - 41 , wherein the subject has cancer (e.g., a gastrointestinal cancer or a non-gastrointestinal cancer). 
     
     
         44 . The composition of  claim 42 , wherein the wasting syndrome is cachexia. 
     
     
         45 . A pharmaceutical composition, medical food, or dietary supplement for use in treating cancer in a human subject comprising an effective amount of a glycan therapeutic preparation to treat the subject. 
     
     
         46 . The composition of  claim 45 , wherein the pharmaceutical composition, medical food, or dietary supplement is administered in combination with a second agent or therapy. 
     
     
         47 . The composition of any one of  claims 45 - 46 , wherein the pharmaceutical composition, medical food, or dietary supplement is administered simultaneously with a second agent or therapy. 
     
     
         48 . The composition of any one of  claims 45 - 46 , wherein the second agent comprises a checkpoint modulator, a cancer vaccine, an anti-cancer biologic, or a chemotherapeutic agent. 
     
     
         49 . The composition of  claim 48 , wherein the immune checkpoint inhibitor comprises an antibody, a fusion protein, or a small molecule. 
     
     
         50 . The composition of  claim 48 , wherein the cancer vaccine comprises a tumor cell vaccine, an antigen vaccine, a dendritic cell vaccine, a DNA vaccine, or a vector based vaccine. 
     
     
         51 . The composition of  claim 48 , wherein the anti-cancer biologic comprises a cytokine or an antibody. 
     
     
         52 . The composition of any one of  claims 45 - 51 , wherein the combination is administered to a subject that has been previously treated for cancer. 
     
     
         53 . The composition of any one of  claims 45 - 51 , wherein the combination is administered to a subject that has been previously not been treated for cancer. 
     
     
         54 . A pharmaceutical composition for use in modulating the composition and/or metabolic activity of the intestinal bacterial community of a subject having cancer, comprising a glycan therapeutic preparation and an anti- or pro-inflammatory agent in an amount effective to modulate the subject's immune system. 
     
     
         55 . A pharmaceutical composition for use in treating a dysbiosis in a subject having cancer comprising a glycan therapeutic preparation in an effective amount to treat the dysbiosis. 
     
     
         56 . The composition of any one of  claims 54 - 55 , wherein the composition further comprises a probiotic microorganism or an anti-cancer agent. 
     
     
         57 . The composition of any one of  claims 54 - 55 , wherein the level of a short-chain fatty acid (SCFA) is modulating in a subject upon administration of the composition. 
     
     
         58 . The composition of any one of  claims 54 - 55 , wherein administration of the composition results in the stimulation of growth or stimulation of activity of beneficial gut bacteria, e.g., Bifidobacteria. 
     
     
         59 . The composition of any one of  claims 54 - 58 , wherein administration of the composition results in the modulation of one or more biomarkers comprising Interleukin 10, Interleukin, 4, Interleukin 13, or Interleukin 35. 
     
     
         60 . The composition of any one of  claims 54 - 58 , wherein administration of the composition results in the modulation of one or more biomarkers comprising C-reactive protein, interleukin-6, interleukin-8, interleukin-18, insulin, blood glucose, leptin, serum amyloid A, serum amyloid P, or tumor necrosis factor-alpha. 
     
     
         61 . The composition of any one of  claims 54 - 58 , wherein administration of the composition results in the modulation of one or more cytokines comprising TNF-α, IL-8, monocyte chemoattracting protein 1 (MCP-1), TGF-β, IL-12, IFN-γ, IL-4, or IL-10. 
     
     
         62 . The composition of any one of  claims 54 - 58 , wherein the subject undergoes an anti-cancer therapy. 
     
     
         63 . The composition of  claim 62 , wherein the cancer therapy is a non-drug therapy. 
     
     
         64 . The composition of  claim 62 , wherein the subject has constipation or diarrhea. 
     
     
         65 . A pharmaceutical composition for use in reducing an infection and/or an inflammation in a subject having cancer, wherein the composition comprises an effective amount of a glycan therapeutic preparation to reduce the infection and/or inflammation in the subject. 
     
     
         66 . A pharmaceutical composition for use in inducing apoptosis of a cancer or a precancerous cell in a subject having cancer comprising a glycan therapeutic preparation in an effective amount to induce apoptosis of the cancer or precancerous cell. 
     
     
         67 . The composition of any one of  claims 65 - 66 , wherein the cancer comprises colon cancer or liver cancer. 
     
     
         68 . The composition of any one of  claims 65 - 66 , wherein the glycan therapeutic preparation is administered in combination with another agent or therapy. 
     
     
         69 . The composition of  claim 68 , wherein the other agent or therapy comprises radiation, chemotherapy, or antibiotic therapy. 
     
     
         70 . The composition of  claim 69 , wherein the other agent comprises a probiotic, a prebiotic dietary fiber, an antibacterial agent, an anti-inflammatory agent, or an anti-cancer agent. 
     
     
         71 . The composition of any one of  claims 65 - 66 , wherein the composition modulates (e.g., directly or indirectly) one or more genes or gene products comprising Jun, Myc, Fos, Adamts1, ATF3, DDit4, Egr1, Sox9, IL1a, Gadd45b, or Gadd45g. 
     
     
         72 . A pharmaceutical composition for use in reducing the risk of cancer in a subject comprising a glycan therapeutic preparation in an effective amount to promote a healthy microbiota in the subject, thereby reducing the cancer risk in the subject. 
     
     
         73 . A pharmaceutical composition for use in modulating the composition of the intestinal bacterial community of a subject having cancer, wherein the composition comprises a glycan therapeutic preparation and an anti-cancer agent in an amount effective to stimulate the growth of beneficial bacteria in the digestive system. 
     
     
         74 . A pharmaceutical composition for use in modulating the metabolic activity of the intestinal bacterial community of a subject having cancer, wherein the composition comprises a glycan therapeutic composition and an anti-cancer agent in an amount effective to modulate the metabolic activity of beneficial bacteria in the digestive system. 
     
     
         75 . The composition of any one of  claims 72 - 74 , further administering an anti-inflammatory agent or a probiotic microorganism. 
     
     
         76 . The composition of any one of  claims 72 - 74 , wherein administration of the composition comprises a change in the diet of the subject. 
     
     
         77 . The composition of any one of  claims 72 - 74 , wherein the cancer comprises a solid cancer or a liquid cancer. 
     
     
         78 . The composition of any one of  claims 72 - 74 , wherein the cancer comprises a metastatic or metastasized tumor. 
     
     
         79 . The composition of any one of  claims 72 - 74 , wherein the cancer is an immunogenic cancer and comprises one or more of the following characteristics:
 (a) tumor infiltrating lymphocytes (TIL);   (b) somatic mutations;   (c) neoantigens;   (d) tertiary lymphoid structures;   (e) high expression of inflammatory gene expression; or   (f) immune cells exhibiting immunosuppressive phenotype.   
     
     
         80 . The composition of any one of  claims 72 - 74 , wherein the cancer comprises a gastrointestinal cancer (e.g., colorectal cancer, pancreatic cancer, gastric cancer, oesophageal cancer, hepatocellular cancer, cholangiocellular cancer, oral cancer, or lip cancer) or a non-gastrointestinal cancer (e.g., urogenital cancer, a gynecological cancer, a lung cancer, a head and neck cancer, a CNS cancer, a malignant mesothelioma; a breast cancer, a skin cancer, a thyroid cancer; a bone and soft tissue sarcoma; or a hematologic neoplasia). 
     
     
         81 . A pharmaceutical composition for use in reducing a symptom of a treatment or therapy in a subject, comprising an effective amount of a glycan therapeutic preparation to thereby reducing a symptom of the treatment or therapy in the subject. 
     
     
         82 . A pharmaceutical composition for use in reducing toxicity of a drug treatment or therapy in a subject in need thereof, comprising an effective amount of a glycan therapeutic preparation to thereby reducing toxicity of a drug treatment or therapy in the subject. 
     
     
         83 . The composition of any one of  claims 81 - 82 , wherein the treatment or therapy is an anti-cancer treatment or therapy. 
     
     
         84 . The composition of any one of  claims 81 - 82 , wherein the treatment or therapy is treatment or therapy for a nutritional imbalance. 
     
     
         85 . The composition of any one of  claims 81 - 82 , wherein the treatment or therapy is treatment or therapy for an immune imbalance. 
     
     
         86 . A pharmaceutical composition for use in treating symptoms associated with gastrointestinal distress comprising an effective amount of a glycan therapeutic preparation comprising a mixture of branched glycans to treat one or more symptom associated with gastrointestinal distress. 
     
     
         87 . The composition of  claim 86 , wherein the symptoms are associated with cancer, a nutritional imbalance, or an immune imbalance. 
     
     
         88 . The composition of any one of  claims 86 - 87 , wherein the composition is administered prior to the onsent of the symptom. 
     
     
         89 . The composition of any one of  claims 86 - 87 , wherein the composition is administered after the onsent of the symptom. 
     
     
         90 . The composition of any one of  claims 86 - 89 , wherein the symptom comprises one or more of abdominal pain, cramping, nausea, vomiting, upset stomach, gas, bloating, flatulence, diarrhea, constipation, heartburn, mucositis, weight-gain, or weight loss. 
     
     
         91 . The composition of any one of  claims 86 - 89 , wherein the symptom comprises one or more of anxiety, fear, depression, mental fog, dermatitis, chest pain, or shortness of breath. 
     
     
         92 . The composition of any one of  claims 86 - 89 , wherein the symptom is dose-limiting for a drug treatment or therapy, thereby preventing the subject from being treated with the maximal efficacious dose of a drug treatment or therapy. 
     
     
         93 . A pharmaceutical composition for use in modulating the function and/or activity of a pathway of a subject having an immune imbalance, comprising an effective amount of a glycan therapeutic preparation. 
     
     
         94 . A pharmaceutical composition for use in modulating the function and/or activity of a pathway of a subject having a nutritional imbalance, comprising an effective amount of a glycan therapeutic preparation. 
     
     
         95 . A pharmaceutical composition for use in modulating the function and/or activity of a pathway of a subject having cancer, comprising an effective amount of a glycan therapeutic preparation. 
     
     
         96 . The composition of any one of  claims 93 - 95 , wherein the pharmaceutical composition is administered in combination with a second agent or therapy. 
     
     
         97 . The composition of any one of  claims 93 - 95 , wherein the pharmaceutical composition is administered simultaneously with a second agent or therapy. 
     
     
         98 . The composition of any one of  claims 93 - 95 , wherein the second agent is a dietary fiber or probiotic bacterium. 
     
     
         99 . The composition of any one of  claims 93 - 95 , wherein the combination is administered to a subject that has been previously treated for an immune imbalance, a nutritional imbalance, or cancer. 
     
     
         100 . The composition of any one of  claims 93 - 95 , wherein the combination is administered to a subject that has been previously not been treated for an immune imbalance, a nutritional imbalance, or cancer. 
     
     
         101 . The composition of any one of  claims 93 - 95 , wherein the level of a short-chain fatty acid (SCFA) is modulating in a subject upon administration of the composition. 
     
     
         102 . The composition of any one of  claims 93 - 95 , wherein administration of the composition results in the stimulation of growth or stimulation of activity of beneficial gut bacteria, e.g., Bifidobacteria. 
     
     
         103 . The composition of any one of  claims 93 - 95 , wherein administration of the composition results in the modulation of one or more biomarkers comprising Interleukin 10, Interleukin, 4, Interleukin 13, or Interleukin 35. 
     
     
         104 . The composition of any one of  claims 93 - 95 , wherein administration of the composition results in the modulation of one or more biomarkers comprising C-reactive protein, interleukin-6, interleukin-8, interleukin-18, insulin, blood glucose, leptin, serum amyloid A, serum amyloid P, or tumor necrosis factor-alpha. 
     
     
         105 . The composition of any one of  claims 93 - 95 , wherein administration of the composition results in the modulation of one or more cytokines comprising TNF-α, IL-8, monocyte chemoattracting protein 1 (MCP-1), TGF-β, IL-12, IFN-γ, IL-4, or IL-10. 
     
     
         106 . The composition of any one of  claims 93 - 95 , wherein one or more pathways are modulated (e.g., inflammatory responses, complement, apoptosis, antigen presentation, oxidative stress, cell adhesion, cytoskeleton remodeling, Notch signaling, Wnt signaling, and/or one or more of the metabolic pathways listed in Table 19). 
     
     
         107 . The composition of any one of the preceding claims, wherein:
 i) the glycan therapeutic preparation comprises branched glycans;   ii) the glycan therapeutic preparation comprises branched glycans that comprise branched oligosaccharides;   iii) the glycan therapeutic preparation comprises an average degree of branching (DB) of at least 0.01;   iv) at least 50% of the glycans in the glycan therapeutic preparation have a degree of polymerization (DP) of at least 3 and less than 30 glycan units;   v) the ratio of alpha- to beta-glycosidic bonds present in the glycans of the glycan therapeutic preparation overall is between about 1:1 to about 5:1; or   vi) any combination of one, two, three, four or five of i), ii), iii), iv) and v).   
     
     
         108 . The composition of  claim 107 , wherein the branched oligosaccharides comprise glucose, galactose, arabinose, mannose, fructose, xylose, fucose, or rhamnose glycan units. 
     
     
         109 . The composition of any one of  claims 107 - 108 , wherein the glycan therapeutic preparation has a final solubility limit in water of at least about 60 Brix at 23° C. 
     
     
         110 . The composition of any one of  claims 107 - 109 , wherein:
 i) the branched glycans comprise a mixture of beta and alpha linkages of one or more of (1-2), (1-3), (1-4), (1-6), (2-3), and (2-6);   ii) the glycan therapeutic preparation comprises a mixture of branched glycans and unbranched glycans;   iii) the glycan therapeutic preparation comprises a mixture of digestible and non-digestible glycans; or   iv) any combination of one, two, or three of i), ii), and iii).   
     
     
         111 . A kit for treating cancer in a human subject, comprising: a package comprising
 (i) a first pharmaceutical composition comprising a glycan therapeutic preparation,   (ii) optionally, a second anti-neoplastic or anti-cancer pharmaceutical composition, and   (iii) instructions for using the first and/or the second pharmaceutical compositions for treating cancer in a human patient.   
     
     
         112 . The kit of  claim 111 , wherein:
 i) the glycan therapeutic preparation comprises branched glycans,   ii) the glycan therapeutic preparation comprises branched glycans that comprise branched oligosaccharides,   iii) the glycan therapeutic preparation has an average degree of branching (DB) of at least 0.01,   iv) at least 50% of the glycans in the preparation have a degree of polymerization (DP) of at least 3 and less than 30 glycan units,   v) the ratio of alpha- to beta-glycosidic bonds present in the glycans of the preparation overall is between about 1:1 to about 5:1, or   vi) any combination of one, two, three, four or five of i), ii), iii), iv) and v).   
     
     
         113 . The kit of  claim 111 , wherein:
 i) the glycan therapeutic preparation comprises branched glycans,   ii) the glycan therapeutic preparation comprises branched glycans that comprise branched oligosaccharides,   iii) the glycan therapeutic preparation comprises branched oligosaccharides that comprise glucose, galactose, arabinose, mannose, fructose, xylose, fucose, or rhamnose glycan units,   iv) the average degree of branching (DB) of the branched glycans in the glycan therapeutic preparation is between 0.01 and 0.3,   v) at least 50% of the glycans in the glycan therapeutic preparation have a degree of polymerization (DP) of at least 3 and less than 30 glycan units,   vi) the average DP of the glycan therapeutic preparation is between about DP6 and about DP10, vii) the ratio of alpha- to beta-glycosidic bonds present in the glycans of the glycan therapeutic preparation is between about 1:1 to about 5:1,   viii) the glycan therapeutic preparation has a final solubility limit in water of at least about 60 Brix at 23° C., or ix) any combination of one, two, three, or four, five, six, seven, or eight of i), ii), iii), iv), v), vi), vii), and viii).   
     
     
         114 . The kit of  claim 111 , wherein:
 i) the glycan therapeutic preparation comprises branched glycans,   ii) the glycan therapeutic preparation comprises branched glycans that comprise one or more glycan units,   iii) the glycan therapeutic preparation comprises branched glycans that comprise at least 1% of branched glycan units,   iv) the glycan therapeutic preparation comprises branched glycans that have a degree of polymerization (DP) of between 2 and 30 glycan units,   v) the glycan therapeutic preparation comprise branched glycans that have a 1:1, 1:2, 1:3, 1:4, or 1:5 beta- to alpha-configuration,   vi) the glycan therapeutic preparation comprises branched glycans that comprise a mixture of beta and alpha linkages of one or more of (1-2), (1-3), (1-4), (1-6), (2-3), and (2-6);   vii) the glycan therapeutic preparation comprises a mixture of branched glycans and unbranched glycans, or   viii) the glycan therapeutic preparation comprises a mixture of digestible and non-digestible glycans.   
     
     
         115 . A unit dosage form effective to treat a disease, disorder, or pathological condition comprising a glycan therapeutic preparation formulated for oral, enteral, rectal, intravenous, or intratumoral administration. 
     
     
         116 . The unit dosage form of  claim 115 , wherein:
 i) the glycan therapeutic preparation comprises branched glycans,   ii) the glycan therapeutic preparation comprises branched glycans that comprise branched oligosaccharides,   iii) the glycan therapeutic preparation has an average degree of branching (DB) of at least 0.01,   iv) at least 50% of the glycans in the preparation have a degree of polymerization (DP) of at least 3 and less than 30 glycan units,   v) the ratio of alpha- to beta-glycosidic bonds present in the glycans of the preparation overall is between about 1:1 to about 5:1, or   vi) any combination of one, two, three, four or five of i), ii), iii), iv) and v).   
     
     
         117 . The unit dosage form of  claim 115 , wherein:
 i) the glycan therapeutic preparation comprises branched glycans,   ii) the glycan therapeutic preparation comprises branched glycans that comprise branched oligosaccharides,   iii) the glycan therapeutic preparation comprises branched oligosaccharides that comprise glucose, galactose, arabinose, mannose, fructose, xylose, fucose, or rhamnose glycan units,   iv) the average degree of branching (DB) of the branched glycans in the glycan therapeutic preparation is between 0.01 and 0.3,   v) at least 50% of the glycans in the glycan therapeutic preparation have a degree of polymerization (DP) of at least 3 and less than 30 glycan units,   vi) the average DP of the glycan therapeutic preparation is between about DP6 and about DP10,   vii) the ratio of alpha- to beta-glycosidic bonds present in the glycans of the glycan therapeutic preparation is between about 1:1 to about 5:1,   viii) the glycan therapeutic preparation has a final solubility limit in water of at least about 60 Brix at 23° C., or ix) any combination of one, two, three, or four, five, six, seven, or eight of i), ii), iii), iv), v), vi), vii), and viii).   
     
     
         118 . The unit dosage form of  claim 115 , wherein:
 i) the glycan therapeutic preparation comprises branched glycans,   ii) the glycan therapeutic preparation comprises branched glycans that comprise one or more glycan units,   iii) the glycan therapeutic preparation comprises branched glycans that comprise at least 1% of branched glycan units,   iv) the glycan therapeutic preparation comprise branched glycans that have a degree of polymerization (DP) of between 2 and 30 glycan units,   v) the glycan therapeutic preparation comprises branched glycans that have a 1:1, 1:2, 1:3, 1:4, or 1:5 beta- to alpha-configuration,   vi) the glycan therapeutic preparation comprises branched glycans that comprise a mixture of beta and alpha linkages of one or more of (1-2), (1-3), (1-4), (1-6), (2-3), and (2-6);   vii) the glycan therapeutic preparation comprises a mixture of branched glycans and unbranched glycans, or   viii) the glycan therapeutic preparation comprises a mixture of digestible and non-digestible glycans.   
     
     
         119 . A composition comprising:
 a) a digestible glycan therapeutic preparation and a substantially non-digestible saccharide or dietary fiber,   b) a substantially non-digestible glycan therapeutic preparation and a digestible saccharide or dietary fiber,   c) a substantially non-digestible glycan therapeutic preparation and a substantially non-digestible saccharide or dietary fiber, or   d) a digestible glycan therapeutic preparation and a digestible saccharide or dietary fiber, and any one of (a), (b), (c), (d) optionally comprising a probiotic bacterium.   
     
     
         120 . The composition of  claim 119 , wherein:
 i) the glycan therapeutic preparation comprises branched glycans,   ii) the glycan therapeutic preparation comprises branched glycans that comprise branched oligosaccharides,   iii) the glycan therapeutic preparation has an average degree of branching (DB) of at least 0.01,   iv) at least 50% of the glycans in the preparation have a degree of polymerization (DP) of at least 3 and less than 30 glycan units,   v) the ratio of alpha- to beta-glycosidic bonds present in the glycans of the preparation overall is between about 1:1 to about 5:1, or   vi) any combination of one, two, three, four or five of i), ii), iii), iv) and v).   
     
     
         121 . The composition of  claim 119 , wherein:
 i) the glycan therapeutic preparation comprises branched glycans,   ii) the branched glycans that comprise branched oligosaccharides,   iii) the branched oligosaccharides comprise glucose, galactose, arabinose, mannose, fructose, xylose, fucose, or rhamnose glycan units,   iv) the average degree of branching (DB) of the branched glycans in the glycan therapeutic preparation is between 0.01 and 0.3, v) at least 50% of the glycans in the glycan therapeutic preparation have a degree of polymerization (DP) of at least 3 and less than 30 glycan units, vi) the average DP of the glycan therapeutic preparation is between about DP6 and about DP10, vii) the ratio of alpha- to beta-glycosidic bonds present in the glycans of the glycan therapeutic preparation is between about 1:1 to about 5:1, viii) the glycan therapeutic preparation has a final solubility limit in water of at least about 60 Brix at 23° C., or ix) any combination of one, two, three, or four, five, six, seven, or eight of i), ii), iii), iv), v), vi), vii), and viii).   
     
     
         122 . The composition of  claim 119 , wherein the glycan therapeutic preparation:
 i) comprises branched glycans;   ii) c branched glycans comprise one or more glycan units;   iii) the branched glycans comprise at least 1% of branched glycan units;   iv) the branched glycans have a degree of polymerization (DP) of between 2 and 30 glycan units;   v) the branched glycans have a 1:1, 1:2, 1:3, 1:4, or 1:5 beta- to alpha-configuration;   vi) the branched glycans comprise a mixture of beta and alpha linkages of one or more of (1-2), (1-3), (1-4), (1-6), (2-3), and (2-6);   vii) the glycan therapeutic preparation comprises a mixture of branched glycans and unbranched glycans,   viii) the glycan therapeutic preparation comprises a mixture of digestible and non-digestible glycans.   
     
     
         123 . A composition for treatment of any of the diseases, disorders, or conditions described herein. 
     
     
         124 . A dosage form comprising the composition of  claim 123 .