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Protocol summary
Objective: The aim of this study is to determine the effects of probiotic supplementation on metabolic profiles in patients with multiple sclerosis. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with multiple sclerosis, higher than 2 years of their disease and aged 20 to 60 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with multiple sclerosis of eligible and referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either probiotic supplements (intervention group: n=30) and placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention. Start and end date of intervention: 3 months. Outcomes: Metabolic profiles will be meseaured at study baseline and end-of-trial.
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Objective: The aim of this study is to determine the effects of probiotic supplementation on metabolic profiles in patients with multiple sclerosis. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with multiple sclerosis, higher than 2 years of their disease and aged 20 to 60 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with multiple sclerosis of eligible and referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either probiotic supplements (intervention group: n=30) and placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention. Start and end date of intervention: 3 months. Outcomes: Metabolic profiles will be meseaured at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر پروفایل های متابولیک در بیماران مبتلا به مولتیپل اسکلروزیس است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به مولتیپل اسکلروزیس، بیشتر از 2 سال از سابقه بیماری آن ها و در محدوده سنی 20 تا 60 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به مولتیپل اسکلروزیس واجد شرایط و ارجاع شده به کلینیک بهشتی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل پروبیوتیک (گروه مداخله:30=n) و پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 3 ماه. پيامدها: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر پروفایل های متابولیک در بیماران مبتلا به مولتیپل اسکلروزیس است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به مولتیپل اسکلروزیس، بیشتر از 2 سال از سابقه بیماری آن ها و در محدوده سنی 20 تا 60 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به مولتیپل اسکلروزیس واجد شرایط و ارجاع شده به کلینیک بهشتی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل پروبیوتیک (گروه مداخله:30=n) و پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 3 ماه. پيامدها: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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he aim of this study is to determine the effects of probiotic supplementation on disease severity and metabolic profiles in patients with multiple sclerosis.
he aim of this study is to determine the effects of probiotic supplementation on disease severity and metabolic profiles in patients with multiple sclerosis.
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هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر شدت بیماری و پروفایل های متابولیک در بیماران مبتلا به مولتیپل اسکلروزیس است.
هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر شدت بیماری و پروفایل های متابولیک در بیماران مبتلا به مولتیپل اسکلروزیس است.
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Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
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تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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60 patients with multiple sclerosis of eligible and referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
60 patients with multiple sclerosis of eligible and referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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60 بیمار مبتلا به مولتیپل اسکلروزیس واجد شرایط و ارجاع شده به کلینیک بهشتی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
60 بیمار مبتلا به مولتیپل اسکلروزیس واجد شرایط و ارجاع شده به کلینیک بهشتی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
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Peoples will be entered in the study if they will be at ages between 18 and 55 with clinically definite RRMS will be diagnosed according to McDonald criteria and an expanded disability status scale (EDSS) score ≤4.5. The participants will be excluded from the study under following conditions: women who were pregnant or lactating during the past six months, patients bearing nephrolithiasis for the past 5 years, menopaused women with irregular menstruation and unwillingness to utilize appropriate contraceptive tools.
Peoples will be entered in the study if they will be at ages between 18 and 55 with clinically definite RRMS will be diagnosed according to McDonald criteria and an expanded disability status scale (EDSS) score ≤4.5. The participants will be excluded from the study under following conditions: women who were pregnant or lactating during the past six months, patients bearing nephrolithiasis for the past 5 years, menopaused women with irregular menstruation and unwillingness to utilize appropriate contraceptive tools.
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افراد در صورتی که در سنین 18 تا 55 سال باشند و دوره RRMS مطابق معیارهای مک دونالد تشخیص داده شده باشند و نمره EDSS کمتر مساوی 4.5 داشته باشند وارد مطالعه خواهند شد. شرکت کنندگان دارای این شرایط از مطالعه خارج شدند: زنانی که طی 6 ماه گذشته حامله بودند یا شیردهی می کردند ، بیمارانی که در 5 سال گذشته دچار نفرولیتیتاسیس شده بودند ، زنان یائسه با قاعدگی نامنظم و عدم تمایل به استفاده از وسایل مناسب پیشگیری از بارداری.
افراد در صورتی که در سنین 18 تا 55 سال باشند و دوره RRMS مطابق معیارهای مک دونالد تشخیص داده شده باشند و نمره EDSS کمتر مساوی 4.5 داشته باشند وارد مطالعه خواهند شد. شرکت کنندگان دارای این شرایط از مطالعه خارج شدند: زنانی که طی 6 ماه گذشته حامله بودند یا شیردهی می کردند ، بیمارانی که در 5 سال گذشته دچار نفرولیتیتاسیس شده بودند ، زنان یائسه با قاعدگی نامنظم و عدم تمایل به استفاده از وسایل مناسب پیشگیری از بارداری.
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Patients will be assigned to receive either probiotic supplements (intervention group: n=30) and placebo (control group: n=30).
Patients will be assigned to receive either probiotic supplements (intervention group: n=30) and placebo (control group: n=30).
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بیماران برای دریافت مکمل پروبیوتیک (گروه مداخله:30=n) و پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد.
بیماران برای دریافت مکمل پروبیوتیک (گروه مداخله:30=n) و پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد.
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Fasting blood samples will be taken at baseline and after 12-wk intervention. Disease severity and metabolic profiles will be meseaured at study baseline and end-of-trial.
Fasting blood samples will be taken at baseline and after 12-wk intervention. Disease severity and metabolic profiles will be meseaured at study baseline and end-of-trial.
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نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. شدت بیماری و پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. شدت بیماری و پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
20
18
2018
60
55
6055
1
1
1
1
1
1
Ages between 18 and 55
The course of RRMS diagnosed according to McDonald criteria
EDSS score ≤4.5
Ages between 18 and 55 The course of RRMS diagnosed according to McDonald criteria EDSS score ≤4.5
سن بین 18 تا 55 سال
دوره RRMS تشخیص داده شده براساس معیار مک دونالد
امتیاز EDSS کمتر مساوی 4.5
سن بین 18 تا 55 سال دوره RRMS تشخیص داده شده براساس معیار مک دونالد امتیاز EDSS کمتر مساوی 4.5
Women who were pregnant
Lactating during the past six months
Nephrolithiasis for the past 5 years
Menopaused women with irregular menstruation
Unwillingness to utilize appropriate contraceptive tools.
Women who were pregnant Lactating during the past six months Nephrolithiasis for the past 5 years Menopaused women with irregular menstruation Unwillingness to utilize appropriate contraceptive tools.
زنان باردار
شیردهی در طول شش ماه گذشته
نفرولیتیتازیس در 5 سال گذشته
زنان یائسه با قاعدگی نامنظم
عدم تمایل به استفاده از وسایل مناسب پیشگیری از بارداری
زنان باردار شیردهی در طول شش ماه گذشته نفرولیتیتازیس در 5 سال گذشته زنان یائسه با قاعدگی نامنظم عدم تمایل به استفاده از وسایل مناسب پیشگیری از بارداری
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either probiotic supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either probiotic supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
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در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل پروبیوتیک (n = 30) و پلاسبو (n = 30) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل پروبیوتیک (n = 30) و پلاسبو (n = 30) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic of Shahid Beheshti Hospital , who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic of Shahid Beheshti Hospital , who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک بیمارستان شهید بهشتی که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک بیمارستان شهید بهشتی که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
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Primary outcomes
#1
Total antioxidant capacity
EDSS
Total antioxidant capacityEDSS
ظرفتیت آنتی اکسیدانی توتال
EDSS
ظرفتیت آنتی اکسیدانی توتالEDSS
Spectrophotometry
Physical Examination by Neurologist
SpectrophotometryPhysical Examination by Neurologist
اسپکتروفتومتری
معاینه فیزیکی توسط متخصص مغز و اعصاب
اسپکتروفتومتریمعاینه فیزیکی توسط متخصص مغز و اعصاب
#2
Malondialdehyde
High-sensitivity C-reactive protein
MalondialdehydeHigh-sensitivity C-reactive protein
مالون دی آلدئید
ﭘﺮوﺗﺌﻴﻦ واﻛﻨﺸﻲ C ﺑﺎ ﺣﺴﺎﺳﻴﺖ ﺑﺎﻻ
مالون دی آلدئیدﭘﺮوﺗﺌﻴﻦ واﻛﻨﺸﻲ C ﺑﺎ ﺣﺴﺎﺳﻴﺖ ﺑﺎﻻ
Spectrophotometry
ELISA kit
SpectrophotometryELISA kit
اسپکتروفتومتری
کیت الایزا
اسپکتروفتومتریکیت الایزا
#3
Glutathione
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Glutathione
گلوتاتیون
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گلوتاتیون
At the beginning of the study and after 12 weeks of intervention
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At the beginning of the study and after 12 weeks of intervention
در ابتدای مطالعه و 12 هفته بعد از مداخله
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در ابتدای مطالعه و 12 هفته بعد از مداخله
Spectrophotometry
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Spectrophotometry
اسپکتروفتومتری
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اسپکتروفتومتری
Secondary outcomes
#1
hs-CRP
Malondialdehyde
hs-CRPMalondialdehyde
پروتئین واکنشگر C با حساسیت بالا
مالون دی آلدئید
پروتئین واکنشگر C با حساسیت بالامالون دی آلدئید
Elisa kit
Spectrophotometry
Elisa kitSpectrophotometry
کیت الایزا
اسپکتروفوتومتری
کیت الایزااسپکتروفوتومتری
#2
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Glutathione
Glutathione
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گلوتاتیون
گلوتاتیون
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Spectrophotometry
Spectrophotometry
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اسپکتروفتومتری
اسپکتروفتومتری
#3
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Total antioxidant capacity
Total antioxidant capacity
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ظرفیت آنتی اکسیدانی تام
ظرفیت آنتی اکسیدانی تام
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Spectrophotometry
Spectrophotometry
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اسپکتروفتومتری
اسپکتروفتومتری
#4
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Insulin resistance
Insulin resistance
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مقاومت به انسولین
مقاومت به انسولین
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Calculation using HOMA formula
Calculation using HOMA formula
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محاسبه با استفاده از فرمول HOMA
محاسبه با استفاده از فرمول HOMA
#5
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General health
General health
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سلامت عمومی
سلامت عمومی
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Standard questionnaire GHQ-28
Standard questionnaire GHQ-28
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پرسشنامه استاندارد 28 سوالی GHQ
پرسشنامه استاندارد 28 سوالی GHQ
#6
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Depression
Depression
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افسردگی
افسردگی
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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depression, anxiety and stress scale
depression, anxiety and stress scale
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مقیاس افسردگی، اضطراب و استرس
مقیاس افسردگی، اضطراب و استرس
#7
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Depression
Depression
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افسردگی
افسردگی
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Beck Depression Inventory
Beck Depression Inventory
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پرسشنامه افسردگی بک
پرسشنامه افسردگی بک
Recruitment centers
#1
Name of recruitment center - English: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Shahid Beheshti Hospital
Name of recruitment center - Persian: بیمارستان شهید بهشتی
Full name of responsible person - English: Ebrahim Kouchaki
Full name of responsible person - Persian: ابراهیم کوچکی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5554 0026
Fax:
Email: beheshtihospital@kaums.ac.ir
Web page address:
Name of recruitment center - English: Naghavi ClinicShahid Beheshti Hospital Name of recruitment center - Persian: کلینیک نقویبیمارستان شهید بهشتی Full name of responsible person - English: Zatollah AsemiEbrahim Kouchaki Full name of responsible person - Persian: ذات اله عاصمیابراهیم کوچکی Street address - English: Shahid Rajaee AvenueGhotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، خیابان شهید رجاییبلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5554 0026 Fax: Email: beheshtihospital@kaums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5554 2999
Fax:
Email: research@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Gholamali Hamidi Full name of responsible person - Persian: غلامعلی حمیدی Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5554 2999 Fax: Email: research@kaums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Vice chancellor for research, Kashan University of Medical Sciences
Kashan University of Medical Sciences
Vice chancellor for research, Kashan University of Medical Sciences
معاونت پژوهشی دانشگاه علوم پزشکی کاشان
دانشگاه علوم پزشکی کاشان
معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English:
Full name of responsible person - Persian:
Position - English:
Position - Persian:
Latest degree:
Area of specialty/work:
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English:
Street address - Persian:
City - English:
City - Persian:
Province:
Province - English:
Province - Persian:
contact.provinces_available:
Country:
Postal code:
Phone:
Mobile:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Nutritionist
Position - Persian: متخصص تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5562 0608
Mobile: +98 913 361 5446
Fax:
Email: asemi_r@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: Nutritionist Position - Persian: متخصص تغذیه Latest degree: phd Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5562 0608 Mobile: +98 913 361 5446 Fax: Email: asemi_r@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکترای تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکترای تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: PhD of Nutrition Position - Persian: دکترای تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: PhD of Nutrition Position - Persian: دکتری تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
Undecided - It is not yet known if there will be a plan to make this available
Undecided - It is not yet known if there will be a plan to make this available
empty
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
Protocol summary
Study aim
he aim of this study is to determine the effects of probiotic supplementation on disease severity and metabolic profiles in patients with multiple sclerosis.
Design
Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
Settings and conduct
60 patients with multiple sclerosis of eligible and referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Peoples will be entered in the study if they will be at ages between 18 and 55 with clinically definite RRMS will be diagnosed according to McDonald criteria and an expanded disability status scale (EDSS) score ≤4.5. The participants will be excluded from the study under following conditions: women who were pregnant or lactating during the past six months, patients bearing nephrolithiasis for the past 5 years, menopaused women with irregular menstruation and unwillingness to utilize appropriate contraceptive tools.
Intervention groups
Patients will be assigned to receive either probiotic supplements (intervention group: n=30) and placebo (control group: n=30).
Main outcome variables
Fasting blood samples will be taken at baseline and after 12-wk intervention. Disease severity and metabolic profiles will be meseaured at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201511015623N59
Registration date:2015-12-02, 1394/09/11
Registration timing:retrospective
Last update:2019-09-23, 1398/07/01
Update count:1
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2015-11-01, 1394/08/10
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in patients with multiple sclerosis
Public title
Effect of supplementation in treatment of patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 18 and 55
The course of RRMS diagnosed according to McDonald criteria
EDSS score ≤4.5
Exclusion criteria:
Women who were pregnant
Lactating during the past six months
Nephrolithiasis for the past 5 years
Menopaused women with irregular menstruation
Unwillingness to utilize appropriate contraceptive tools.
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either probiotic supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic of Shahid Beheshti Hospital , who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2015-10-28, 1394/08/06
Ethics committee reference number
IR.Kaums.REC.1394.81
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
EDSS
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Physical Examination by Neurologist
2
Description
High-sensitivity C-reactive protein
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
ELISA kit
Secondary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Fasting blood sugar
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
9
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
10
Description
General health
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Standard questionnaire GHQ-28
11
Description
Depression
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
depression, anxiety and stress scale
12
Description
Depression
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Beck Depression Inventory
Intervention groups
1
Description
Intervention group: Probiotic capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/g) and Lactobacillus fermentum (2×109 CFU/g), daily, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule, daily, for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Ebrahim Kouchaki
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0026
Email
beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5562 0608
Email
asemi_r@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available