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
BACKGROUND There are various studies showing the relationship between irritable bowel syndrome(IBS)and diet,and some dietary adjustments are recommended to reduce symptoms.In recent years,there is a growing number of ...BACKGROUND There are various studies showing the relationship between irritable bowel syndrome(IBS)and diet,and some dietary adjustments are recommended to reduce symptoms.In recent years,there is a growing number of studies that show a 4-8 wk low fermentable oligo,di-and mono-saccharides and polyols(FODMAP)diet has a 50%-80%significant effect on symptoms in IBS patients.There is strong evidence suggesting that changes in fecal microbiota have an impact on IBS pathogenesis.Based on this argument,probiotics have been used in IBS treatment for a long time.As is seen,the FODMAP diet and probiotics are used separately in IBS treatment.AIM To evaluate the effectiveness of adding probiotics to a low FODMAP diet to control the symptoms in patients with IBS.METHODS The patients who were admitted to the Gastroenterology Clinic of Dokuz Eylul University Hospital and diagnosed with IBS according to Rome IV criteria were enrolled into the study.They were randomized into 2 groups each of which consisted of 50 patients.All patients were referred to a dietitian to receive dietary recommendations for the low FODMAP diet with a daily intake of 9 g.The patients were asked to keep a diary of foods and beverages they consumed.The patients in Group 1 were given supplementary food containing probiotics(2 g)once a day in addition to their low FODMAP diet,while the patients in Group 2 were given a placebo once a day in addition to their low FODMAP diet.Visual analogue scale(VAS),the Bristol Stool Scale and IBS Symptom Severity Scale(IBSSSS)scores were evaluated before and after the 21 d treatment.RESULTS The rate of adherence of 85 patients,who completed the study,to the FODMAP restricted diet was 92%,being 90%in Group 1 and 94%in Group 2.The mean scores of VAS and IBS-SSS of the patients in Group 1 before treatment were 4.6±2.7 and 310.0±78.4,respectively,and these scores decreased to 2.0±1.9 and 172.0±93.0 after treatment(both P<0.001).The mean VAS and IBS-SSS scores of the patients in Group 2 before treatment were 4.7±2.7 and 317.0±87.5,respectively,and these scores decreased to 1.8±2.0 and 175.0±97.7 after treatment(both P<0.001).The IBS-SSS score of 37 patients(86.04%)in Group 1 and 36 patients(85.71%)in Group 2 decreased by more than 50 points.Group 1 and Group 2 were similar in terms of differences in VAS and IBS-SSS scores before and after treatment.When changes in stool shape after treatment were compared using the Bristol Stool Scale,both groups showed significant change.CONCLUSION This study is the randomized controlled study to examine the efficiency of probiotic supplementation to a low FODMAP diet in all subtypes of IBS.The low FODMAP diet has highly positive effects on symptoms of all subtypes of IBS.It was seen that adding probiotics to a low FODMAP diet does not make an additional contribution to symptom response and adherence to the diet.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BACKGROUND There are various studies showing the relationship between irritable bowel syndrome(IBS)and diet,and some dietary adjustments are recommended to reduce symptoms.In recent years,there is a growing number of studies that show a 4-8 wk low fermentable oligo,di-and mono-saccharides and polyols(FODMAP)diet has a 50%-80%significant effect on symptoms in IBS patients.There is strong evidence suggesting that changes in fecal microbiota have an impact on IBS pathogenesis.Based on this argument,probiotics have been used in IBS treatment for a long time.As is seen,the FODMAP diet and probiotics are used separately in IBS treatment.AIM To evaluate the effectiveness of adding probiotics to a low FODMAP diet to control the symptoms in patients with IBS.METHODS The patients who were admitted to the Gastroenterology Clinic of Dokuz Eylul University Hospital and diagnosed with IBS according to Rome IV criteria were enrolled into the study.They were randomized into 2 groups each of which consisted of 50 patients.All patients were referred to a dietitian to receive dietary recommendations for the low FODMAP diet with a daily intake of 9 g.The patients were asked to keep a diary of foods and beverages they consumed.The patients in Group 1 were given supplementary food containing probiotics(2 g)once a day in addition to their low FODMAP diet,while the patients in Group 2 were given a placebo once a day in addition to their low FODMAP diet.Visual analogue scale(VAS),the Bristol Stool Scale and IBS Symptom Severity Scale(IBSSSS)scores were evaluated before and after the 21 d treatment.RESULTS The rate of adherence of 85 patients,who completed the study,to the FODMAP restricted diet was 92%,being 90%in Group 1 and 94%in Group 2.The mean scores of VAS and IBS-SSS of the patients in Group 1 before treatment were 4.6±2.7 and 310.0±78.4,respectively,and these scores decreased to 2.0±1.9 and 172.0±93.0 after treatment(both P<0.001).The mean VAS and IBS-SSS scores of the patients in Group 2 before treatment were 4.7±2.7 and 317.0±87.5,respectively,and these scores decreased to 1.8±2.0 and 175.0±97.7 after treatment(both P<0.001).The IBS-SSS score of 37 patients(86.04%)in Group 1 and 36 patients(85.71%)in Group 2 decreased by more than 50 points.Group 1 and Group 2 were similar in terms of differences in VAS and IBS-SSS scores before and after treatment.When changes in stool shape after treatment were compared using the Bristol Stool Scale,both groups showed significant change.CONCLUSION This study is the randomized controlled study to examine the efficiency of probiotic supplementation to a low FODMAP diet in all subtypes of IBS.The low FODMAP diet has highly positive effects on symptoms of all subtypes of IBS.It was seen that adding probiotics to a low FODMAP diet does not make an additional contribution to symptom response and adherence to the diet.
