US2021161839A1PendingUtilityA1

Methods and compositions to modulate the gut microbiota and to manage weight

Assignee: XENO BIOSCIENCES INCPriority: Jun 1, 2015Filed: Jan 26, 2021Published: Jun 3, 2021
Est. expiryJun 1, 2035(~8.8 yrs left)· nominal 20-yr term from priority
Inventors:Hasan Celiker
A61P 3/00A61K 31/327A61K 33/40A61K 31/185A61K 38/44A61K 9/4866A61K 9/2846A61K 9/2866A61P 3/04A61K 31/17A61K 9/4891C12Y 111/01006A61K 33/00A61K 9/0053
68
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Claims

Abstract

Methods of weight management for a subject are provided. Generally the methods comprising: administering an effective amount to the small intestine and/or large intestine of the subject of at least one agent that increases oxygen tension and/or redox potential and/or pH in the colon of the subject to thereby manage the weight of the subject. Also provided are compositions comprising at least one agent that increases oxygen tension and/or redox potential and/or pH, wherein the composition is formulated for delivery of an effective amount of the at least one agent to the small intestine and/or large intestine of a subject following oral administration of the composition to the subject.

Claims

exact text as granted — not AI-modified
1 - 58 . (canceled) 
     
     
         59 . A method of treating a metabolic disorder, the method comprising:
 orally administering to a subject in need thereof a tablet, troche, pill or, capsule comprising an enterically-coated oxygen-releasing composition comprising a peroxide,   wherein the enterically-coated oxygen-releasing composition is characterized in that it achieves release of oxygen when assayed in PBS buffer at pH 7.4 after immersion at pH 1.2 for 2 hours.   
     
     
         60 . The method of  claim 59 , wherein the peroxide comprises a peroxide selected from the group consisting of sodium percarbonate and carbamide peroxide. 
     
     
         61 . The method of  claim 59 , wherein the metabolic disorder is selected from type 2 diabetes, hypertension, and dyslipidemia. 
     
     
         62 . The method of  claim 59 , wherein the metabolic disorder is glucose intolerance. 
     
     
         63 . The method of  claim 62 , wherein the method lowers blood glucose. 
     
     
         64 . The method of  claim 62 , wherein the method lowers fasting blood glucose. 
     
     
         65 . The method of  claim 59 , wherein the metabolic disorder is selected from insulin-deficiency, insulin-resistance, syndrome X, osteoarthritis, metabolic syndrome, non-alcoholic fatty liver disease, hypertension, high cholesterol, hypercholesterolemia, atherosclerosis, and coronary artery disease. 
     
     
         66 . The method of  claim 59 , wherein the composition is further characterized in that, when contacted with a sample containing both anaerobic and aerobic bacteria, an increase in the relative abundance of aerobic bacteria is achieved. 
     
     
         67 . The method of  claim 59 , wherein the composition comprises a dose of 5 mg to 100 mg of hydrogen peroxide equivalent. 
     
     
         68 . The method of  claim 59 , wherein the composition comprises a dose of 20 mg to 40 mg of hydrogen peroxide equivalent. 
     
     
         69 . The method of  claim 59 , wherein the enteric coating dissolves at a pH above 6.0. 
     
     
         70 . The method of  claim 59 , wherein the composition is formulated for sustained release. 
     
     
         71 . The method of  claim 59 , wherein the release of oxygen is measured by a dissolved oxygen meter. 
     
     
         72 . A method of treating a metabolic disorder, the method comprising:
 orally administering to a subject who is in need thereof a tablet, troche, pill, capsule, or powder comprising an oxygen-releasing composition formulated for enteric delivery of its active to the small intestine and/or large intestine of the subject, wherein the active is or comprises a peroxide.   
     
     
         73 . The method of  claim 72 , wherein the peroxide comprises a peroxide selected from the group consisting of sodium percarbonate and carbamide peroxide. 
     
     
         74 . The method of  claim 72 , wherein the metabolic disorder is selected from type 2 diabetes, hypertension, and dyslipidemia. 
     
     
         75 . The method of  claim 72 , wherein the metabolic disorder is glucose intolerance. 
     
     
         76 . The method of  claim 75 , wherein the method lowers blood glucose. 
     
     
         77 . The method of  claim 75 , wherein the method lowers fasting blood glucose. 
     
     
         78 . The method of  claim 72 , wherein the metabolic disorder is selected from insulin-deficiency, insulin-resistance, syndrome X, osteoarthritis, metabolic syndrome, non-alcoholic fatty liver disease, hypertension, high cholesterol, hypercholesterolemia, atherosclerosis, and coronary artery disease. 
     
     
         79 . The method of  claim 72 , wherein the composition is further characterized in that, when contacted with a sample containing both anaerobic and aerobic bacteria, an increase in the relative abundance of aerobic bacteria is achieved. 
     
     
         80 . The method of  claim 72 , wherein the active is administered at a dose of 5 mg to 100 mg of hydrogen peroxide equivalent. 
     
     
         81 . The method of  claim 72 , wherein the active is administered at a dose of 20 mg to 40 mg of hydrogen peroxide equivalent. 
     
     
         82 . The method of  claim 72 , wherein the composition is administered as an oral dosage form comprising the active and an enteric coating encasing the active. 
     
     
         83 . The method of  claim 82 , wherein the enteric coating dissolves at a pH above 6.0. 
     
     
         84 . The method of  claim 82 , wherein the enteric coating dissolves at a pH above 7.0. 
     
     
         85 . The method of  claim 82 , wherein the oral dosage form is formulated for sustained release. 
     
     
         86 . A method of treating glucose intolerance in a human subject in need thereof, the method comprising:
 orally administering to a subject a tablet, troche, pill or capsule containing an enterically coated oxygen-releasing composition comprising a peroxide.   
     
     
         87 . The method of  claim 86 , wherein the peroxide comprises a peroxide selected from the group consisting of sodium percarbonate and carbamide peroxide. 
     
     
         88 . The method of  claim 86 , wherein the method lowers blood glucose. 
     
     
         89 . The method of  claim 86 , wherein the method lowers fasting blood glucose. 
     
     
         90 . The method of  claim 86 , wherein the glucose intolerance comprises type 2 diabetes. 
     
     
         91 . The method of  claim 86 , wherein the composition is further characterized in that, when contacted with a sample containing both anaerobic and aerobic bacteria, an increase in the relative abundance of aerobic bacteria is achieved. 
     
     
         92 . The method of  claim 86 , wherein the composition is administered at a dose of 5 mg to 100 mg of hydrogen peroxide equivalent. 
     
     
         93 . The method of  claim 86 , wherein the composition is administered at a dose of 20 mg to 40 mg of hydrogen peroxide equivalent. 
     
     
         94 . The method of  claim 86 , wherein the enteric coating dissolves at a pH above 6.0. 
     
     
         95 . The method of  claim 86 , wherein the enteric coating dissolves at a pH above 7.0. 
     
     
         96 . The method of  claim 86 , wherein the composition is formulated for sustained release. 
     
     
         97 . A method comprising a step of:
 orally administering to a subject in need of treatment of a metabolic disorder a tablet, troche, pill or, capsule comprising an enterically coated oxygen-releasing composition comprising a peroxide.   
     
     
         98 . The method of  claim 97 , wherein the composition achieves delivery preferentially to the small and/or large intestine.

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