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Clinical trial of the effect of probiotic supplementation compared with the placebo on disease severity, mental health, insulin resistance, inflammatory factors and biomarkers of oxidative stress in patients with multiple sclerosis

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History
# Registration date Revision Id
3 2019-09-04, 1398/06/13 103420
2 2017-09-15, 1396/06/24 26351
1
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of probiotic supplementation on insulin resistance, inflammatory factors and biomarkers of oxidative stress 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: 48 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=24) and placebo (control group: n=24). Fasting blood samples will be taken at baseline and after 16-wk intervention. Start and end date of intervention: 4 months. Outcomes: insulin resistance, inflammatory factors and biomarkers of oxidative stress will be measured at study baseline and end-of-trial
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر مقاومت به انسولین، فاکتورهای التهابی و بیومارکرهای استرس اکسیداتیو 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: 48 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:24=n) و پلاسبو (گروه کنترل: 24=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 16 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 4 ماه. پيامدها: مقاومت به انسولین، فاکتورهای التهابی و بیومارکرهای استرس اکسیداتیو در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    The aim of this study is to determine the effects of probiotic supplementation on disease severity, mental health, insulin resistance, inflammatory factors and biomarkers of oxidative stress in patients with multiple sclerosis.
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    هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر شدت بیماری، سلامت روان، مقاومت به انسولین، فاکتورهای التهابی و بیومارکرهای استرس اکسیداتیو 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. 48 patients with multiple sclerosis of eligible in the study will be selected. Patients will be assigned to receive either probiotic supplements and placebo. Fasting blood samples will be taken at baseline and after 16-wk intervention.
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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. 48 بیمار مبتلا به مولتیپل اسکلروزیس واجد شرایط در مطالعه انتخاب خواهند شد. بیماران برای دریافت مکمل پروبیوتیک و پلاسبو تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 16 هفته بعد از مداخله از بیماران گرفته خواهد شد.
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    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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    بیماران 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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    The inclusion criteria were patients with ages between 20 and 60, course of disease relapsing–remitting MS (RRMS), identified according to McDonald criteria and an expanded disability status scale (EDSS) score ≤4.5 referred to the Neurology Clinic of Shahid Beheshti Hospital in Kashan city, Iran. The exclusion criteria were primary progressive MS (PPMS), secondary progressive MS (SPMS), clinical relapse and glucocorticoid therapy during the past one month, pregnancy, women who were lactating within the prior six month, patients with bearing nephrolithiasis within the prior five years and consumers of probiotic or synbiotic during the past three month.
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    معیار ورود بیماران با محدوده سنی بین 20 تا 60 سال، دوره بیماری عود کننده، بهبود یابنده (RRMS)، تشخیص داده شده براساس معیار مک دونالد و EDSS کمتر مساوی 4.5، مراجعه کننده به کلینیک نورولوژی بیمارستان شهید بهشتی کاشان، ایران بود. معیار خروج دوره پیشرونده اولیه ام اس (PPMS)، دوره پیشرونده ثانویه ام اس (SPMS)، عود بیماری و گلوکوکورتیکوئید درمانی در طول یک ماه گذشته، بارداری، شیردهی در طول شش ماه گذشته، بیماران مبتلا به نفرولیتیازیس در طول پنج سال گذشته و مصرف کنندگان پروبیوتیک و سین بیوتیک در طول سه ماه گذشته بودند.
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    Patients will be assigned to receive either probiotic supplements (intervention group: n=24) and placebo (control group: n=24).
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    بیماران برای دریافت مکمل پروبیوتیک (گروه مداخله:24=n) و پلاسبو (گروه کنترل: 24=n) تقسیم خواهند شد.
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    Disease severity, mental health, insulin resistance, inflammatory factors and biomarkers of oxidative stress will be measured at study baseline and end-of-trial
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    شدت بیماری، سلامت روان، مقاومت به انسولین، فاکتورهای التهابی و بیومارکرهای استرس اکسیداتیو در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

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    2017-09-01, 1396/06/10
    2017-09-17, 1396/06/26
    Clinical trial of the effect of probiotic supplementation compared with the placebo on insulin resistance, inflammatory factors and biomarkers of oxidative stress in patients with multiple sclerosis
    Clinical trial of the effect of probiotic supplementation compared with the placebo on disease severity, mental health, insulin resistance, inflammatory factors and biomarkers of oxidative stress in patients with multiple sclerosis
    کارآزمایی بالینی اثر مکمل یاری پروبیوتیک در مقایسه با پلاسبو بر مقاومت به انسولین، فاکتورهای التهابی و بیومارکرهای استرس اکسیداتیو در بیماران مبتلا به مولتیپل اسکلروزیس
    کارآزمایی بالینی اثر مکمل یاری پروبیوتیک در مقایسه با پلاسبو بر شدت بیماری، سلامت روان، مقاومت به انسولین، فاکتورهای التهابی و بیومارکرهای استرس اکسیداتیو در بیماران مبتلا به مولتیپل اسکلروزیس
    Patients with multiple sclerosis identified according to McDonald criteria
    Course of disease relapsing–remitting MS (RRMS)
    EDSS ≤4.5
    یماران مبتلا به مولتیپل اسکلروزیس تشخیص داده شده براساس معیار مک دونالد
    دوره بیماری عودت‌کننده-بهبود یابنده ام اس (RRMS)
    EDSS کمتر مساوی 4.5
    Primary progressive MS (PPMS)
    Secondary progressive MS (SPMS)
    Relapse and glucocorticoid therapy during the past one month
    Pregnancy
    Women who were lactating within the prior six month
    Nephrolithiasis
    Consumption of of probiotic or synbiotic during the past three month
    دوره بیماری پیشرونده اولیه ام اس (PPMS)
    دوره بیماری پیشرونده ثانویه ام اس (SPMS)
    عود و گلوکوکورتیکوئید درمانی در طول یک ماه گذشته
    بارداری
    زنانی که در طی شش ماه گذشته شیردهی می کردند
    نفرولیتیازیس
    مصرف پروبیوتیک یا سین بیوتیک در طول سه ماه گذشته
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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 = 24) or placebo (n = 24). 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 = 24) و پلاسبو (n = 24) 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 Shahid Beheshti Clinic, 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 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
    ظرفتیت آنتی اکسیدانی توتال
    EDSS
    Spectrophotometry
    Physical Examination by Neurologist
    اسپکتروفتومتری
    معاینه فیزیکی توسط متخصص مغز و اعصاب
    #2
    Malondialdehyde
    high sensitivity C-reactive protein
    مالون دی آلدئید
    پروتئین واکنشگر C با حساسیت بالا
    Spectrophotometry
    Elisa kit
    اسپکتروفتومتری
    کیت الایزا
    #3
    Glutathione
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    گلوتاتیون
    empty
    At the beginning of the study and after 16 weeks of intervention
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    در ابتدای مطالعه و 16 هفته بعد از مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
    empty
    #4
    8-hydroxydeoxyguanosine
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    8- هیدروکسی دی آکسی گوانوزین
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    At the beginning of the study and after 16 weeks of intervention
    empty
    در ابتدای مطالعه و 16 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #5
    super oxide dismutase
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    سوپراکسید دیسموتاز
    empty
    At the beginning of the study and after 16 weeks of intervention
    empty
    در ابتدای مطالعه و 16 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty

  • Secondary outcomes

    #1
    hs-CRP
    Interleukin 6
    پروتئین واکنشی C با حساسیت بالا
    اینترلوکین-6
    #2
    Interleukin 6
    Interleukin 10
    اینترلوکین-6
    اینترلوکین-10
    #3
    Interleukin 10
    Tumor necrosis factor alpha
    اینترلوکین-10
    ﻓﺎﮐﺘﻮر ﻧﮑﺮوز دﻫﻨﺪه ﺗﻮﻣﻮر آﻟﻔﺎ
    #4
    Tumor necrosis factor alpha
    8-hydroxydeoxyguanosine
    ﻓﺎﮐﺘﻮر ﻧﮑﺮوز دﻫﻨﺪه ﺗﻮﻣﻮر آﻟﻔﺎ
    8- هیدروکسی دی آکسی گوانوزین
    #5
    empty
    Superoxide dismutase
    empty
    سوپر اکسید دیسموتاز
    empty
    At the beginning of the study and after 16 weeks of intervention
    empty
    در ابتدای مطالعه و 16 هفته بعد از مداخله
    empty
    ELISA kit
    empty
    کیت الایزا
    #6
    empty
    Glutathione
    empty
    گلوتاتیون
    empty
    At the beginning of the study and after 16 weeks of intervention
    empty
    در ابتدای مطالعه و 16 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #7
    empty
    Malondialdehyde
    empty
    مالون دی آلدئید
    empty
    At the beginning of the study and after 16 weeks of intervention
    empty
    در ابتدای مطالعه و 16 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #8
    empty
    Total antioxidant capacity
    empty
    ظرفیت آنتی اکسیدانی توتال
    empty
    At the beginning of the study and after 16 weeks of intervention
    empty
    در ابتدای مطالعه و 16 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #9
    empty
    Depression
    empty
    افسردگی
    empty
    At the beginning of the study and after 16 weeks of intervention
    empty
    در ابتدای مطالعه و 16 هفته بعد از مداخله
    empty
    Beck Depression Inventory
    empty
    پرسشنامه افسردگی بک
    #10
    empty
    General Health
    empty
    سلامت عمومی
    empty
    At the beginning of the study and after 16 weeks of intervention
    empty
    در ابتدای مطالعه و 16 هفته بعد از مداخله
    empty
    General Health Questionnaire (28 item)
    empty
    پرسشنامه سلامت عمومی (28 سوالی)
    #11
    empty
    Depression
    empty
    افسردگی
    empty
    At the beginning of the study and after 16 weeks of intervention
    empty
    در ابتدای مطالعه و 16 هفته بعد از مداخله
    empty
    depression, anxiety and stress scale
    empty
    مقیاس افسردگی، اضطراب و استرس

  • 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: Kasham
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Neurology Clinic of Shahid Beheshti Hospital
    Name of recruitment center - Persian: کلینیک نورولوژی 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: Kasham
    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:
    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:
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    Public
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    Domestic
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    Academic

  • Person responsible for general 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: 00
    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: 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:

  • 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: Mahmoud Salami
    Full name of responsible person - Persian: محمود سلامی
    Position - English: PhD of Physiology
    Position - Persian: دکترای فیزیولوژی
    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 5562 1157
    Mobile: 00
    Fax:
    Email: salami-m@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: Mahmoud Salami
    Full name of responsible person - Persian: محمود سلامی
    Position - English: PhD of Physiology
    Position - Persian: دکترای فیزیولوژی
    Latest degree: phd
    Area of specialty/work: 69
    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 1157
    Mobile: +98 913 361 5446
    Fax:
    Email: salami-m@kaums.ac.ir
    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: Omid Reza Tamtaji
    Full name of responsible person - Persian: امید رضا تمتاجی
    Position - English: MSc student of medical physiology
    Position - Persian: دانشجوی کارشناسی ارشد فیزیولوژی پزشکی
    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 5562 1157
    Mobile: +98 913 361 5446
    Fax:
    Email: tamtaji_or@yahoo.com, tamtaji-or@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: Omid Reza Tamtaji
    Full name of responsible person - Persian: امید رضا تمتاجی
    Position - English: MSc student of medical physiology
    Position - Persian: دانشجوی کارشناسی ارشد فیزیولوژی پزشکی
    Latest degree: master
    Area of specialty/work: 69
    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 1157
    Mobile: +98 938 842 5546
    Fax:
    Email: tamtaji-or@kaums.ac.ir
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    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

Protocol summary

Study aim
The aim of this study is to determine the effects of probiotic supplementation on disease severity, mental health, insulin resistance, inflammatory factors and biomarkers of oxidative stress 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. 48 patients with multiple sclerosis of eligible in the study will be selected. Patients will be assigned to receive either probiotic supplements and placebo. Fasting blood samples will be taken at baseline and after 16-wk intervention.
Settings and conduct
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
The inclusion criteria were patients with ages between 20 and 60, course of disease relapsing–remitting MS (RRMS), identified according to McDonald criteria and an expanded disability status scale (EDSS) score ≤4.5 referred to the Neurology Clinic of Shahid Beheshti Hospital in Kashan city, Iran. The exclusion criteria were primary progressive MS (PPMS), secondary progressive MS (SPMS), clinical relapse and glucocorticoid therapy during the past one month, pregnancy, women who were lactating within the prior six month, patients with bearing nephrolithiasis within the prior five years and consumers of probiotic or synbiotic during the past three month.
Intervention groups
Patients will be assigned to receive either probiotic supplements (intervention group: n=24) and placebo (control group: n=24).
Main outcome variables
Disease severity, mental health, insulin resistance, inflammatory factors and biomarkers of oxidative stress will be measured at study baseline and end-of-trial

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2017082234497N2
Registration date: 2017-09-15, 1396/06/24
Registration timing: registered_while_recruiting

Last update: 2019-09-14, 1398/06/23
Update count: 1
Registration date
2017-09-15, 1396/06/24
Registrant information
Name
Omid Reza Tamtaji
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5562 1157
Email address
tamtaji-or@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-08-17, 1396/05/26
Expected recruitment end date
2017-09-17, 1396/06/26
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 disease severity, mental health, insulin resistance, inflammatory factors and biomarkers of oxidative stress in patients with multiple sclerosis
Public title
Effect of supplementation in treatment of patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with multiple sclerosis identified according to McDonald criteria Course of disease relapsing–remitting MS (RRMS) EDSS ≤4.5
Exclusion criteria:
Primary progressive MS (PPMS) Secondary progressive MS (SPMS) Relapse and glucocorticoid therapy during the past one month Pregnancy Women who were lactating within the prior six month Nephrolithiasis Consumption of of probiotic or synbiotic during the past three month
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 48
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 = 24) or placebo (n = 24). 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 Shahid Beheshti Clinic, 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
Random assignment will be done by the use of computer-generated random numbers.

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
8715988141
Approval date
2017-08-16, 1396/05/25
Ethics committee reference number
IR.Kaums.MEDNT.REC.1396.28

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 16 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 16 weeks of intervention
Method of measurement
Elisa kit

Secondary outcomes

1

Description
Insulin
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
ELISA

2

Description
Fasting blood sugar
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Enzymatic kit

3

Description
Nitric oxide
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Spectrophotometry

4

Description
Interleukin 6
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
ELISA kit

5

Description
Interleukin 10
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
ELISA kit

6

Description
Tumor necrosis factor alpha
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
ELISA kit

7

Description
8-hydroxydeoxyguanosine
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
ELISA kit

8

Description
Superoxide dismutase
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
ELISA kit

9

Description
Glutathione
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Spectrophotometry

10

Description
Malondialdehyde
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Spectrophotometry

11

Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Spectrophotometry

12

Description
Depression
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
Beck Depression Inventory

13

Description
General Health
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
General Health Questionnaire (28 item)

14

Description
Depression
Timepoint
At the beginning of the study and after 16 weeks of intervention
Method of measurement
depression, anxiety and stress scale

Intervention groups

1

Description
Intervention group: Probiotic capsule containing four strains of Bifidobacterium infantis (2×109 CFU/g), Lactobacillus reuteri (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g), lactobacillus plantarum (2×109 CFU/g), lactobacillus fermentum (2×109 CFU/g), and bifidobacterium lactis (2×109 CFU/g), daily, for 16 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo capsule, daily, for 16 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurology Clinic of Shahid Beheshti Hospital
Full name of responsible person
Ebrahim Kouchaki
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kasham
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
Vice chancellor for research, 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
Vice chancellor for research, 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
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 scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahmoud Salami
Position
PhD of Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5562 1157
Fax
Email
salami-m@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
Omid Reza Tamtaji
Position
MSc student of medical physiology
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5562 1157
Fax
Email
tamtaji-or@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
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