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WO 2016/172658 A2 27 October 2016 (27.10.2016) P O P C T

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WO 2016/172658 A2 27 October 2016 (27.10.2016) P O P C T (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2016/172658 A2 27 October 2016 (27.10.2016) P O P C T (51) International Patent Classification: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, A61K 31/702 (2006.01) BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (21) International Application Number: HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, PCT/US20 16/029083 KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, (22) International Filing Date: MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, 23 April 2016 (23.04.2016) PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, (25) Filing Language: English TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (26) Publication Language: English (84) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of regional protection available): ARIPO (BW, GH, 62/152,005 23 April 2015 (23.04.2015) US GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, 62/152,007 23 April 2015 (23.04.2015) US TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, 62/152,017 23 April 2015 (23.04.2015) US TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, 62/152,016 23 April 2015 (23.04.2015) US DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, 62/152,01 1 23 April 2015 (23.04.2015) US LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, 62/255,366 13 November 2015 (13. 11.2015) US SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, 62/255,365 13 November 2015 (13. 11.2015) US GW, KM, ML, MR, NE, SN, TD, TG). (71) Applicant: KALEIDO BIOSCIENCES, INC. [US/US]; Declarations under Rule 4.17 : 47 Moulton St, Cambridge, MA 02 138 (US). — as to applicant's entitlement to applyfor and be granted a patent (Rule 4.1 7(H)) (72) Inventors: VON MALTZAHN, Geoffrey, A.; 42 Myrtle St Apt Bl, Somerville, MA 02145 (US). GEREMIA, — as to the applicant's entitlement to claim the priority of the John, M.; 42 Myrtle St Apt Bl, Watertown, MA (US). earlier application (Rule 4.1 7(in)) (74) Agent: MYERS, P., Louis; Lando & Anastasi, LLP, Published: Riverfront Office Park, One Main Street, Suite 1100, Cam — without international search report and to be republished bridge, MA 02142 (US). upon receipt of that report (Rule 48.2(g)) (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, (54) Title: MICROBIOME REGULATORS AND RELATED USES THEREOF (57) Abstract: Compositions comprising microbiome regulators are provided, as well as methods of using the same for the modula tion of the human microbiota and to treat or prevent related diseases, disorders, or conditions. MICROBIOME REGULATORS AND RELATED USES THEREOF CLAIM OF PRIORITY This application claims priority to U.S. Application No. 62/255,365, filed November 13, 2015; U.S. Application No. 62/255,366, filed November 13, 2015; U.S. Application No. 62/152,016, filed April 23, 2015; U.S. Application No. 62/152,017, filed April 23, 2015; U.S. Application No. 62/152,011, filed April 23, 2015; U.S. Application No. 62/152,007, filed April 23, 2015; and U.S. Application No. 62/152,005, filed April 23, 2015. The disclosure of each of the foregoing applications is incorporated herein by reference in its entirety. BACKGROUND The microbiota of humans is complex. The microbiota performs many activities and may influence the physiology of the host. Changing the numbers and species of gut microbiota can alter community function and interaction with the host. A limited number of probiotic bacteria is known in the art, and some association with health benefits have been documented when ingested by humans. Certain 'prebiotic' foods contain substances that promote the growth of particular bacterial strains that are thought to be beneficial to the human host. The results of clinical tests with these substances are conflicted with respect to their efficacy, and their influence on human health is generally described as being modest. Thus, there is a need for novel therapeutics that can stimulate beneficial microbiota shifts and improve human health. SUMMARY OF THE INVENTION The present invention features compounds and compositions comprising a microbiome regulator and methods thereof to treat and prevent various diseases, disorders, or conditions. In one aspect, the present invention features a dosage form comprising a composition comprising a microbiome regulator wherein the dosage form targets the release of the composition substantially in the gastrointestinal tract (e.g., the stomach, small intestine and large intestine). In some embodiments, the microbiome regulator comprises a sugar, a sugar alcohol, an amino acid, a peptide, a micronutrient, a fatty acid, or a polyphenol. In some embodiments, the microbiome regulator comprises at least two microbiome regulators (e.g., a sugar, a sugar alcohol, an amino acid, a peptide, a micronutrient, a fatty acid, or a polyphenol). In some embodiments, the microbiome regulator comprises at least three microbiome regulators (e.g., a sugar, a sugar alcohol, an amino acid, a peptide, a micronutrient, a fatty acid, or a polyphenol). In some embodiments, the microbiome regulator comprises a sugar or sugar alcohol. In some embodiments, the microbiome regulator comprises a sugar or sugar alcohol that is metabolizable by the host. In some embodiments, the microbiome regulator comprises a sugar or sugar alcohol that is non-metabolizable by the host. In some embodiments, the sugar or sugar alcohol comprises a monosaccharide, disaccharide, trisaccharide, tetrasaccharide, or pentasaccharide. In some embodiments, the sugar or sugar alcohol comprises a monosaccharide. In some embodiments, the sugar or sugar alcohol comprises a disaccharide, trisaccharide, tetrasaccharide, or pentasaccharide. In some embodiments, the sugar or sugar alcohol comprises a disaccharide, trisaccharide, tetrasaccharide, or pentasaccharide, and at least one, at least two, at least three, at least four, or more of the glycosidic bonds independently comprise a l->2 glycosidic bond, a l->3 glycosidic bond, a l->4 glycosidic bond, or a l->6 glycosidic bond. In some embodiments, the sugar or sugar alcohol comprises a disaccharide, trisaccharide, tetrasaccharide, or pentasaccharide, and at least one, at least two, at least three, at least four, or more of the glycosidic bonds are present in the alpha or beta configuration. In some embodiments, the sugar or sugar alcohol comprises glucose, galactose, fructose, fucose, mannose, xylose, arabinose, rhamnose, ribose, sucrose, sorbose, lactose, sorbitol, maltose, mannitol, lactulose, lactitol, erythritol, tagatose, kojibiose, nigerose, isomaltose, trehalose, sophorose, laminaribiose, gentiobiose, turanose, maltulose, palatinose, gentiobiulose, mannobiose, melibiulose, rutinulose, or xylobiose. In some embodiments, the sugar or sugar alcohol comprises galactose, fructose, fucose, mannose, xylose, arabinose, rhamnose, ribose, sucrose, sorbose, lactose, sorbitol, maltose, mannitol, lactulose, lactitol, erythritol, tagatose, kojibiose, nigerose, isomaltose, trehalose, sophorose, laminaribiose, gentiobiose, turanose, maltulose, palatinose, gentiobiulose, mannobiose, melibiulose, rutinulose, or xylobiose. In some embodiments, the the sugar or sugar alcohol does not comprise glucose. In some embodiments, the sugar or sugar alcohol comprises glucose, galactose, fructose, fucose, mannose, xylose, arabinose, rhamnose, ribose, sucrose, lactose, sorbitol, or maltose. In some embodiments, the sugar or sugar alcohol is galactose, fructose, fucose, mannose, xylose, arabinose, rhamnose, ribose, sucrose, lactose, sorbitol, or maltose. In some embodiments, the sugar or sugar alcohol is metabolizable by the host and comprises glucose, galactose, fructose, fucose, mannose, xylose, ribose, sucrose, lactose, sorbitol, maltose, mannitol, or erythritol. In some embodiments, the sugar or sugar alcohol is metabolizable by the host and comprises galactose, fructose, fucose, mannose, xylose, ribose, sucrose, lactose, sorbitol, maltose, mannitol, or erythritol. In some embodiments, the composition comprises more than about 50% (w/w) of a sugar or sugar alcohol (e.g., more than about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, about 96%, about 97%, about 98%, about 99%, or more). In some embodiments, the composition comprises more than about 50% (w/w) of a sugar or sugar alcohol (e.g., more than about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, about 96%, about 97%, about 98%, about 99%, or more) that is metabolizable by the host. In some embodiments, the microbiome regulator comprises glucose. In some embodiments, the microbiome regulator comprises galactose. In some embodiments, the microbiome regulator comprises fucose. In some embodiments, the microbiome regulator comprises fructose. In some embodiments, the microbiome regulator comprises mannose. In some embodiments, the microbiome regulator comprises xylose. In some embodiments, the microbiome regulator comprises arabinose. In some embodiments, the microbiome regulator comprises rhamnose. In some embodiments, the microbiome regulator comprises sucrose. In some embodiments, the microbiome regulator comprises lactose. In some embodiments, the microbiome regulator comprises maltose. In some embodiments, the microbiome regulator comprises a molecule with a molecular weight less than about 1000 g/mol (e.g., less than about 950 g/mol, about 900 g/mol, about 850 g/mol, about 800 g/mol, about 750 g/mol, about 700 g/mol, about 650 g/mol, about 600 g/mol, about 500 g/mol, about 450 g/mol, about 400 g/mol, about 350 g/mol, about 300 g/mol, about 250 g/mol, about 200 g/mol, or less).
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