Methods and compositions for treating bile acid diarrhea, diarrhea associated with small intestine resection or gallbladder removal, and short bowel syndrome
Inventors
Conte, Lisa A. • Chaturvedi, Pravin R. • Conte, Charles
Assignees
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Publication Number
US-11779564-B2
Publication Date
2023-10-10
Expiration Date
Abstract
Presented herein are methods for treating bile acid diarrhea, short bowel syndrome (SBS), and cholecystectomy-associated diarrhea by administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea. In particular embodiments, infants, and juveniles with SBS are treated with an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea. Treatment of diarrhea includes the treatment of the diarrhea as well as the pain, abdominal discomfort and other symptoms associated with diarrhea. In one embodiment, the inhibitor of chloride-ion transport is crofelemer.
Core Innovation
The invention relates to a method of treating short bowel syndrome (SBS) or secretory diarrhea associated therewith in a subject by administering a proanthocyanidin polymer composition from Croton lechleri. The method uses an amount of the proanthocyanidin polymer composition effective to treat SBS or secretory diarrhea associated therewith.
The problem addressed is diarrhea associated with short bowel syndrome and related secretory diarrhea conditions, including diarrhea after cholecystectomy and small-intestine resection-associated diarrhea. The background describes enterohepatic bile acid physiology and SBS-associated secretory diarrhea to secretory mechanisms linked to CFTR chloride secretion, including bile acid diarrhea subtypes (Type 1, Type 2, and Type 3 bile acid malabsorption).
The disclosed approach is further directed to clinically relevant SBS outcome domains, including reduced stool frequency and watery stools, improved stool consistency, reduced stool urgency and incontinence, and improved nutrition, hydration, and electrolytes. The partial content also states improvements relevant to SBS complications, including improved hepatic and biliary disorders and reduced risk of liver failure.
Claims Coverage
The independent claim is directed to administering a Croton lechleri proanthocyanidin polymer composition in an effective amount to treat short bowel syndrome (SBS) or secretory diarrhea associated therewith. Dependent claims add treatment timing for infants, necrotizing enterocolitis, resection contexts, anatomical absence patterns, and expanded therapeutic effects on SBS-associated complications.
Proanthocyanidin polymer composition from C. lechleri for treating SBS or secretory diarrhea associated therewith
Administering to a subject in need thereof an amount of a proanthocyanidin polymer composition from C. lechleri effective to treat short bowel syndrome (SBS) or secretory diarrhea associated therewith.
Treatment of SBS or secretory diarrhea in infant subjects within defined time windows after birth
Applying the method to a subject to be treated who is an infant within one week, within two weeks, within one month, or within six months after birth.
Necrotizing enterocolitis-associated treatment context
Applying the method when the subject has necrotizing enterocolitis.
Resection refinement involving a portion of the large intestine or colon
Further comprising resecting a portion of the large intestine or colon.
Anatomical absence pattern across duodenum, jejunum, and ileum
Performing the method when the subject lacks all or part of the duodenum, the jejunum, the ileum, or any combination of these.
Improvement of SBS-associated hepatic and/or biliary disorders and reduction in liver failure risk
Including effects that improve SBS-associated hepatic and/or biliary disorders and/or reduce the risk or incidence of liver failure, and/or improve hypotension and related SBS-associated conditions such as metabolic bone disease, small bowel bacterial overgrowth, enteric hyperoxaluria, D-lactic acidosis, risk of infection, and wound healing.
Overall, the claim set centers on using a C. lechleri proanthocyanidin polymer composition administered in an effective amount to treat SBS or secretory diarrhea associated therewith, with dependent features refining timing for infants, specifying necrotizing enterocolitis, specifying resection and anatomical absence contexts, and expanding therapeutic effects to hepatic/biliary disorders, reduction of liver failure risk, and multiple SBS-associated complications.
Stated Advantages
Reduced stool frequency and watery stools.
Improved stool consistency.
Reduced stool urgency and incontinence.
Improved nutrition, hydration, and electrolytes.
Improved hepatic and biliary disorders.
Reduced risk of liver failure.
Improved hypotension and related SBS-associated conditions including metabolic bone disease, small bowel bacterial overgrowth, enteric hyperoxaluria, D-lactic acidosis, risk of infection, and wound healing.
Documented Applications
Treating short bowel syndrome (SBS) or secretory diarrhea associated therewith in a subject.
Treatment in infant subjects within defined time windows after birth (within one week, within two weeks, within one month, or within six months).
Treatment when the subject has necrotizing enterocolitis.
Use in clinical contexts involving resection including a portion of the large intestine or colon.
Use in subjects lacking all or part of the duodenum, jejunum, ileum, or any combination of these.
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