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Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in patients with diabetic hemodialysis

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History
# Registration date Revision Id
3 2019-09-26, 1398/07/04 109138
2 2016-03-23, 1395/01/04 6099
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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 diabetic hemodialysis. 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 diabetic hemodialysis and aged 18 to 80 years will be included in this study. Exclusion criteria: Pregnant women, intestinal diseases, change in type and dosage of insulin, taking probiotic supplements and other forms of probiotics including probiotic yogurt, kefir and other fermented foods, taking prebiotic, taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids, taking antibiotics, immunosuppressive medications within 3 months prior to the enrollment in the study will be excluded in the study. Population and sample size: 60 patients with diabetic hemodialysis of eligible and referred to Akhavan 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: 12 weeks. Outcomes: Metabolic profiles will be meseaured at study baseline and end-of-trial
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر پروفایل های متابولیک در بیماران مبتلا به همودیالیز دیابتیک 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 همودیالیز دیابتیک در محدوده سنی 18 تا 80 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: زنان باردار، بیماری های روده ای، تغییر در نوع و دوز انسولین، گرفتن مکمل پروبیوتیک و سایر فرم های پروبیوتیک از قبیل ماست پروبیوتیک، کفیر و سایر غذاهای تخمیری، گرفتن مکمل آنتی اکسیدانت و ضد التهابی از قبیل ویتامین E، ویتامین C و اسیدهای چرب امگا-3، گرفتن آنتی بیوتیک ها، داروهای سرکوب کننده ایمنی در طول سه ماه قبل نام نویسی در مطالعه از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به همودیالیز دیابتیک واجد شرایط و ارجاع شده به کلینیک اخوان 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: 12 هفته. پيامدها: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    Objective: The aim of this study is to determine the effects of probiotic supplementation on metabolic profiles in patients with diabetic hemodialysis.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر پروفایل های متابولیک در بیماران مبتلا به همودیالیز دیابتیک است.
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    Study design: randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive supplement (n=30) or placebo (n=30).
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    طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
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    Among diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size.
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    از بین بیماران همودیالیزی دیابتیک ارجاع شده به کلینیک اخوان وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند.
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    Inclusion criteria: Patients with diabetic hemodialysis aged 18 to 80 years. Exclusion criteria: Pregnant women, intestinal diseases, taking probiotic supplements and other forms of probiotics including probiotic yogurt, kefir and other fermented foods, taking prebiotic, antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids, taking antibiotics, immunosuppressive medications within 3 months prior to the enrollment in the study.
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    معیار ورود به مطالعه: بیماران مبتلا به همودیالیز دیابتیک در محدوده سنی 18 تا 80 سال. معیار خروج از مطالعه: زنان باردار، بیماری های روده ای، گرفتن مکمل پروبیوتیک و سایر فرم های پروبیوتیک از قبیل ماست پروبیوتیک، کفیر و سایر غذاهای تخمیری، گرفتن پری بیوتیک، مکمل آنتی اکسیدانت و ضد التهابی از قبیل ویتامین E، ویتامین C و اسیدهای چرب امگا-3، گرفتن آنتی بیوتیک ها، داروهای سرکوب کننده ایمنی در طول سه ماه قبل نام نویسی در مطالعه.
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    Intervention group: Probiotic supplements containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, for 12 weeks orally.Control group: Placebo, daily, for 12 weeks orally.
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    گروه مداخله: مکمل پروبیوتیک حاوی 3 سویه لاکتوباسیلوس اسیدوفیلوس (109×2 واحد به ازای هر گرم)، لاکتوباسیلوس کازئی (109×2 واحد به ازای هر گرم) و بیفیدوباکتریوم بیفیدوم (109×2 واحد به ازای هر گرم)، روزانه، به صورت خوراکی برای 12 هفته.گروه کنترل: پلاسبو، روزانه، به صورت خوراکی برای 12 هفته.
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    Outcomes: Glycemic control (primary outcomes), and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
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    پيامدها: گلیسمیک کنترل (پیامدهای اولیه) و پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامد ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

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    Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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    بخاطر یک اشتباه، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شد. اگرچه، اصلاحات مطابق با یا پروپوزال تصویب شده اولیه یا با هماهنگی معاونت پژوهشی دانشگاه بود.
    Inclusion criteria: Patients with diabetic hemodialysis aged 18 to 80 years.
    معیار ورود به مطالعه: بیماران مبتلا به همودیالیز دیابتیک در محدوده سنی 18 تا 80 سال.
    Pregnant women
    Intestinal diseases
    Taking probiotic supplements and other forms of probiotics including probiotic yogurt, kefir and other fermented foods
    Taking prebiotic, antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids
    Taking antibiotics, immunosuppressive medications within 3 months prior to the enrollment in the study
    زنان باردار،
    بیماری های روده ای
    گرفتن مکمل پروبیوتیک و سایر فرم های پروبیوتیک از قبیل ماست پروبیوتیک، کفیر و سایر غذاهای تخمیری
    گرفتن پری بیوتیک، مکمل آنتی اکسیدانت و ضد التهابی از قبیل ویتامین E، ویتامین C و اسیدهای چرب امگا-3
    گرفتن آنتی بیوتیک ها، داروهای سرکوب کننده ایمنی در طول سه ماه قبل نام نویسی در مطالعه
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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 supplementation (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 یاری (n=30) و پلاسبو (n=30) تخصیص داده می شوند. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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    شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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  • Primary outcomes

    #1
    Questionnaire
    Calcution using HOMA formula
    پرسشنامه
    محاسبه شده با استفاده از فرمول HOMA
    #2
    Hs-CRP
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    پروتئین واکنشگر C با حساسیت بالا
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    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
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    Elisa kit
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    کیت الایزا
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    #3
    Total antioxidant capacity
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    ظرفتیت آنتی اکسیدانی توتال
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    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
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    Spectrophotometry
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    اسپکتروفتومتری
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    #4
    Malondialdehyde
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    مالون دی آلدئید
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    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
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    Spectrophotometry
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    اسپکتروفتومتری
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  • Secondary outcomes

    #1
    Added at 2016-08-09: Lipid profiles
    Triglycerides
    بروزرسانی 1395/5/19: لیپید پروفایل ها
    تری گلیسرید
    Added at 2016-08-09: At the beginning of the study and 12 weeks after the intervention
    At the beginning of the study and 12 weeks after the intervention
    بروزرسانی 1395/5/19: در ابتدای مطالعه و 12 هفته بعد از مداخله
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    Added at 2016-08-09: Enzymatic
    Enzymatic kit
    بروزرسانی 1395/5/19: آنزیمی
    کیت آنزیمی
    #2
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    Total cholesterol
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    کلسترول تام
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Enzymatic kit
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    کیت آنزیمی
    #3
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    HDL
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    HDL
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Enzymatic kit
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    کیت آنزیمی
    #4
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    Total antioxidant
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    توتال آنتی اکسیدانت
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
    #5
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    Glutathione
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    گلوتاتیون
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
    #6
    empty
    Malondialdehyde
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    مالون دی آلدئید
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
    #7
    empty
    Nitric oxide
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    نیتریک اکساید
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
    #8
    empty
    Hs-CRP
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    Hs-CRP
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Elisa kit
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    کیت الایزا
    #9
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    Creatinine
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    کراتی نین
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Enzymatic kit
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    کیت آنزیمی
    #10
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    BUN
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    BUN
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Enzymatic kit
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    کیت آنزیمی
    #11
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    Albumin
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    آلبومین
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Enzymatic kit
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    کیت آنزیمی
    #12
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    TIBC
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    TIBC
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Enzymatic kit
    empty
    کیت آنزیمی
    #13
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    LDL
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    LDL
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Enzymatic kit
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    کیت آنزیمی
    #14
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    VLDL
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    VLDL
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Enzymatic kit
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    کیت آنزیمی
    #15
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    Sodium
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    سدیم
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Flame photometry
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    فلیم فتومتری
    #16
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    Potassium
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    پتاسیم
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Flame photometry
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    فلیم فتومتری
    #17
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    Hemoglobin A1c
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    هموگلوبین A1c
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    At the beginning of the study and 12 weeks after the intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Glycomat kit
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    کیت گلیکومت

  • Recruitment centers

    #1
    Name of recruitment center - English: Akhavan Clinic
    Name of recruitment center - Persian: کلینیک اخوان
    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: Akhavan Clinic
    Name of recruitment center - Persian: کلینیک اخوان
    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: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5546 3378
    Fax:
    Email: asemi_r@yahoo.com
    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: 8115187159
    Phone: +98 31 5554 0022
    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:
    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:
    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: Associate professor
    Position - Persian: دانشیار
    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: 8115187159
    Phone: +98 31 5546 3378
    Mobile: 00
    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:
    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: 8115187159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: 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: 8115187159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_r@yahoo.com
    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
Objective: The aim of this study is to determine the effects of probiotic supplementation on metabolic profiles in patients with diabetic hemodialysis.
Design
Study design: randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive supplement (n=30) or placebo (n=30).
Settings and conduct
Among diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with diabetic hemodialysis aged 18 to 80 years. Exclusion criteria: Pregnant women, intestinal diseases, taking probiotic supplements and other forms of probiotics including probiotic yogurt, kefir and other fermented foods, taking prebiotic, antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids, taking antibiotics, immunosuppressive medications within 3 months prior to the enrollment in the study.
Intervention groups
Intervention group: Probiotic supplements containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, for 12 weeks orally.Control group: Placebo, daily, for 12 weeks orally.
Main outcome variables
Outcomes: Glycemic control (primary outcomes), and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.

General information

Reason for update
Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
Acronym
IRCT registration information
IRCT registration number: IRCT201603185623N69
Registration date: 2016-03-23, 1395/01/04
Registration timing: retrospective

Last update: 2019-10-28, 1398/08/06
Update count: 1
Registration date
2016-03-23, 1395/01/04
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
2016-02-29, 1394/12/10
Expected recruitment end date
2016-03-10, 1394/12/20
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 diabetic hemodialysis
Public title
Effect of supplementation in treatment of patients with diabetic hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients with diabetic hemodialysis aged 18 to 80 years.
Exclusion criteria:
Pregnant women Intestinal diseases Taking probiotic supplements and other forms of probiotics including probiotic yogurt, kefir and other fermented foods Taking prebiotic, antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids Taking antibiotics, immunosuppressive medications within 3 months prior to the enrollment in the study
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
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 supplementation (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
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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
8115187159
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
IR.Kaums.REC.1394.166

Health conditions studied

1

Description of health condition studied
همودیالیز
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease

Primary outcomes

1

Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

2

Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calcution using HOMA formula

Secondary outcomes

1

Description
Triglycerides
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Enzymatic kit

2

Description
Total cholesterol
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Enzymatic kit

3

Description
HDL
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Enzymatic kit

4

Description
Total antioxidant
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

5

Description
Glutathione
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

6

Description
Malondialdehyde
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

7

Description
Nitric oxide
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry

8

Description
Hs-CRP
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Elisa kit

9

Description
Creatinine
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Enzymatic kit

10

Description
BUN
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Enzymatic kit

11

Description
Albumin
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Enzymatic kit

12

Description
TIBC
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Enzymatic kit

13

Description
LDL
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Enzymatic kit

14

Description
VLDL
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Enzymatic kit

15

Description
Sodium
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Flame photometry

16

Description
Potassium
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Flame photometry

17

Description
Hemoglobin A1c
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Glycomat kit

Intervention groups

1

Description
Intervention group: Probiotic supplements containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, for 12 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo, daily, for 12 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhavan Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com

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
8115187159
Phone
+98 31 5554 0022
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
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
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
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
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
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
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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