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Effectiveness of an amino acid beverage formulation in diarrheapredominant irritable bowel syndrome:A pragmatic real-world study

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world Journal of Gastrointestinal Pharmacology and Therapeutics 2023年第5期14卷 39-49页

作者： Samantha E Niles Phil Blazy Samuel N Cheuvront robert w kenefick Sadasivan Vidyasagar Adam BSmith Neil Fawkes william Denman Department of Research and Development Entrinsic BioscienceNorwoodMA 02062United States Department of Radiation Oncology University of FloridaGainesvilleFL 32611United States Department of Anesthesiology Massachusetts General HospitalBostonMA 02114United States

BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant *** bowel syndrome(IBS)is a gastrointestinal disorder that affects up to 9% of people globally,with diarrhea predominant IBS(IBS-D)being the most prevalent *** trials are needed to explore potential added benefits when integrated into standard care for *** To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with *** This is a pragmatic,real world,open label,single arm study comparing a 2-week baseline assessment to a 2-week intervention *** hundred adults,aged 18 to 65 years,with IBS-D,according to Rome IV criteria,were enrolled after completing a 2-week baseline assessment period and received a 2-week supply of an amino acid based medical food which was consumed at home twice daily on top of their standard of *** primary outcome was an assessment of tolerability after 2-weeks of consumption,while secondary outcomes included changes in stool consistency(Bristol Stool Form Scale),severity of abdominal pain&discomfort,symptoms of urgency,Global Improvement Survey(GIS),and the IBS severity scoring system(IBS-SSS).RESULTS The test product was well-tolerated as each participant successfully completed the full 14-day trial,and there were no instances of dropouts or discontinuation of the study product *** percent of participants achieved a 50% or more reduction in the number of days with type 6-7 bowel movements(IBS-D stool consistency responders).Fifty-three percent of participants achieved a clinically meaningful reduction of 30% in mean weekly pain scores,and 55%experienced the same for mean weekly discomfort scores(IBS-D pain and discomfort responders).Participants experienced a mean-109.4(95% confidence interval:-130.1,-88.8)point reduction on the IBS-SSS and 52% experienced a minimal

关键词： Diarrhea-predominant irritable bowel syndrome Amino acid beverage formulation Pragmatic real-world study Medical food Bristol Stool Form Scale Irritable Bowel Syndrome–Severity Scoring System

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