US2022133759A1PendingUtilityA1

Synthetic composition

Assignee: GLYCOM ASPriority: May 19, 2016Filed: Jan 17, 2022Published: May 5, 2022
Est. expiryMay 19, 2036(~9.8 yrs left)· nominal 20-yr term from priority
A61P 25/00A61K 31/702A61P 1/00
65
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Claims

Abstract

A method of increasing the relative abundance of Bifidobacterium adolescentis in the gastrointestinal tract and regulating levels of one or both of tryptophan and serotonin in a non-infant human is disclosed. In some examples, the method is effective for treating migraines. The method includes administering for an initial treatment period an amount of one or more human milk oligosaccharides (HMOs) selected from 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), lacto-N-fucopentaose I (LNFP-I), difucosyllactose (DFL), lacto-N-tetraose (LNT), and lacto-N-neotetraose (LNnT), where the amount is effective to increase the relative abundance of Bifidobacterium adolescentis in the gastrointestinal tract of the non-infant human.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of increasing the relative abundance of  Bifidobacterium adolescentis  in the gastrointestinal tract and regulating levels of one or both of tryptophan and serotonin in a non-infant human, the method comprising
 administering for an initial treatment period an amount of one or more human milk oligosaccharides (HMOs) selected from 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), lacto-N-fucopentaose I (LNFP-I), difucosyllactose (DFL), lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), and combinations thereof,   wherein the amount is effective to increase the relative abundance of  Bifidobacterium adolescentis  in the gastrointestinal tract of the non-infant human.   
     
     
         2 . The method of  claim 1 , wherein the non-infant human is an irritable bowel syndrome (IBS) patient. 
     
     
         3 . The method of  claim 1 , wherein during the initial treatment period the selected total amount of the one or more HMOs that is effective to increase the relative abundance of  Bifidobacterium adolescentis  in the gastrointestinal tract of the non-infant human is from 3 g to 10 g per day. 
     
     
         4 . The method of  claim 1 , wherein the selected amount of the one or more HMOs is effective to increase the level of serotonin in the blood of the non-infant human. 
     
     
         5 . The method of  claim 1 , wherein administering to the non-infant human the selected amount of the one or more HMOs further comprises:
 administering, during a maintenance treatment period of one or more days following the initial treatment period, a reduced amount, relative to the selected amount administered during the initial treatment period, of the one or more HMOs that is effective for increasing the relative abundance of one or both of  Bifidobacterium longum  and  Bifidobacterium  bifidum in the microbiota in the gastrointestinal tract of the non-infant human.   
     
     
         6 . The method of  claim 5 , wherein the maintenance treatment period is at least one month. 
     
     
         7 . The method of  claim 1 , wherein the selected amount of the one or more HMOs is effective to decrease the concentration of one or both of IFN-γ and TNF-α in the blood of the non-infant human. 
     
     
         8 . A method of increasing the relative abundance of  Bifidobacterium adolescentis  and regulating serotonin to improve gut motility in a non-infant human with irritable bowel syndrome (IBS), the method comprising:
 selecting an effective amount of one or more human milk oligosaccharides (HMOs) chosen from the group consisting of 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), lacto-N-fucopentaose I (LNFP-I), difucosyllactose (DFL), lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), and combinations thereof; and   increasing the relative abundance of  Bifidobacterium adolescentis  in the gastrointestinal tract of the non-infant human and regulating serotonin to improve gut motility by administering to the non-infant human the selected amount of the one or more HMOs during an initial treatment period.   
     
     
         9 . The method of  claim 8 , wherein during the initial treatment period the selected total amount of the one or more HMOs that is effective to increase the relative abundance of  Bifidobacterium adolescentis  in the gastrointestinal tract of the non-infant human is from 3 g to 10 g per day. 
     
     
         10 . The method of  claim 8 , wherein the selected amount of the one or more HMOs is effective to increase the level of serotonin in the blood of the non-infant human. 
     
     
         11 . The method of  claim 8 , wherein administering to the non-infant human the selected amount of the one or more HMOs further comprises:
 administering, during a maintenance treatment period of one or more days following the initial treatment period, a reduced amount, relative to the selected amount administered during the initial treatment period, of the one or more HMOs that is effective for increasing the relative abundance of one or both of  Bifidobacterium longum  and  Bifidobacterium  bifidum in the microbiota in the gastrointestinal tract of the non-infant human.   
     
     
         12 . The method of  claim 8 , wherein the non-infant human is an IBS-D patient and the method further comprises decreasing stool frequency and improving stool consistency by administering to the non-infant human the selected amount of the mixture. 
     
     
         13 . The method of  claim 8 , wherein the non-infant human is an IBS-C patient and the method further comprises increasing stool frequency and softening stool consistency by administering to the non-infant human the selected amount of the mixture. 
     
     
         14 . The method of  claim 8 , wherein the non-infant human is an IBS-A patient and the method further comprises normalizing stool frequency and stool consistency by administering to the non-infant human the selected amount of the mixture. 
     
     
         15 . A method for treating migraines associated with serotonin dysregulation in a non-infant human, the method comprising:
 selecting an effective amount of one or more human milk oligosaccharides (HMOs) chosen from the group consisting of 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), lacto-N-fucopentaose I (LNFP-I), difucosyllactose (DFL), lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), and combinations thereof, the amount effective for increasing a relative abundance of  Bifidobacterium adolescentis  in the gastrointestinal microbiota of the non-infant human;   regulating serotonin synthesis in the non-infant human by increasing the relative abundance of  Bifidobacterium adolescentis  in the gastrointestinal tract non-infant human by administering the effective amount of the selected HMOs to the non-infant human for an initial treatment period of at least 14 days, thereby treating the migraines in the non-infant human.   
     
     
         16 . The method of  claim 15 , wherein during the initial treatment period the selected total amount of the one or more HMOs that is effective to increase the relative abundance of  Bifidobacterium adolescentis  in the gastrointestinal tract of the non-infant human is from 3 g to 10 g per day. 
     
     
         17 . The method of  claim 15 , wherein the selected amount of the one or more HMOs is effective to increase the level of serotonin in the blood of the non-infant human. 
     
     
         18 . The method of  claim 15 , wherein administering to the non-infant human the selected amount of the one or more HMOs further comprises:
 administering, during a maintenance treatment period of one or more days following the initial treatment period, a reduced amount, relative to the selected amount administered during the initial treatment period, of the one or more HMOs that is effective for increasing the relative abundance of one or both of  Bifidobacterium longum  and  Bifidobacterium bifidum  in the gastrointestinal tract of the non-infant human.   
     
     
         19 . The method of  claim 15 , wherein the maintenance treatment period is at least one month. 
     
     
         20 . The method of  claim 16 , wherein the selected amount of the one or more HMOs is effective to decrease the concentration of one or both of IFN-γ and TNF-α in the blood of the non-infant human.

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