BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastroint...BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable 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 subtype.Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D.AIM To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D.METHODS This is a pragmatic,real world,open label,single arm study comparing a 2-week baseline assessment to a 2-week intervention period.One 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 care.The 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 reported.Forty 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 minimally clinically important difference of>95 points.An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants.For functional symptoms,76% of participants reported symptom relief on the GIS.CONCLUSION The amino acid-based medical food was well-tolerated,when added to the standard of care,and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.展开更多
Irritable bowel syndrome with diarrhea is a very frequent clinical condition characterized by disabling intestinal symptoms.This disease presents with daily abdominal pain for at least 3 months related to defecation a...Irritable bowel syndrome with diarrhea is a very frequent clinical condition characterized by disabling intestinal symptoms.This disease presents with daily abdominal pain for at least 3 months related to defecation and associated with a change in the frequency of bowel movements and the shape of the stool.International surveys about this disease report a global prevalence of about 1.5%.A new amino acid based electrolyte solution has recently been commercialized for oral rehydration in diarrhea.It is composed of water,electrolytes,and five selected amino acids that function as sodium co-transporters without containing glucose.In recent years,some studies explored the effectiveness of the amino acid based electrolyte beverage in oncologic patients with gastrointestinal mucositis,reporting good results.Recently,a prospective study to evaluate the clinical impact of the amino acid based medical beverage was conducted in patients with diarrhea predominant irritable bowel syndrome.The research was based on a real-life methodology minimizing the disruption of the routine care.One hundred patients suffering from irritable bowel syndrome with diarrhea drank a solution based on selected amino acids twice a day for 2 wk.Each enrolled patient completed the study and showed a significant response rate with regard to stool consistency and pain reduction.Based on this data,we can hypothesize that the amino acid based oral rehydration solution could be a valid tool in the treatment of patients affected by irritable bowel syndrome with diarrhea.It is certainly necessary to plan highquality clinical trials comparing glucose based oral solutions and amino acid based solutions in patients with persisting diarrhea.Probably in the near future all oral rehydration solutions will contain amino acids.展开更多
文摘BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable 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 subtype.Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D.AIM To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D.METHODS This is a pragmatic,real world,open label,single arm study comparing a 2-week baseline assessment to a 2-week intervention period.One 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 care.The 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 reported.Forty 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 minimally clinically important difference of>95 points.An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants.For functional symptoms,76% of participants reported symptom relief on the GIS.CONCLUSION The amino acid-based medical food was well-tolerated,when added to the standard of care,and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.
文摘Irritable bowel syndrome with diarrhea is a very frequent clinical condition characterized by disabling intestinal symptoms.This disease presents with daily abdominal pain for at least 3 months related to defecation and associated with a change in the frequency of bowel movements and the shape of the stool.International surveys about this disease report a global prevalence of about 1.5%.A new amino acid based electrolyte solution has recently been commercialized for oral rehydration in diarrhea.It is composed of water,electrolytes,and five selected amino acids that function as sodium co-transporters without containing glucose.In recent years,some studies explored the effectiveness of the amino acid based electrolyte beverage in oncologic patients with gastrointestinal mucositis,reporting good results.Recently,a prospective study to evaluate the clinical impact of the amino acid based medical beverage was conducted in patients with diarrhea predominant irritable bowel syndrome.The research was based on a real-life methodology minimizing the disruption of the routine care.One hundred patients suffering from irritable bowel syndrome with diarrhea drank a solution based on selected amino acids twice a day for 2 wk.Each enrolled patient completed the study and showed a significant response rate with regard to stool consistency and pain reduction.Based on this data,we can hypothesize that the amino acid based oral rehydration solution could be a valid tool in the treatment of patients affected by irritable bowel syndrome with diarrhea.It is certainly necessary to plan highquality clinical trials comparing glucose based oral solutions and amino acid based solutions in patients with persisting diarrhea.Probably in the near future all oral rehydration solutions will contain amino acids.
