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Effects of probiotic supplementation on inflammatory factors and biomarkers of oxidative stress in

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History
# Registration date Revision Id
2 2019-09-25, 1398/07/03 106289
1 2015-03-10, 1393/12/19 6068
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of probiotic supplementation on preventing abortion, inflammatory factors and biomarkers of oxidative stress in pregnant women with spontaneously abortion. Study design: Double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with spontaneously abortion will be included in this study. The use of substitute treatments including hormone or vitamin supplements as well as those with pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 60 patients with spontaneously abortion among pregnant women of eligible and referred to Kossar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either probiotic supplement containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei(2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g) (intervention group: n=30) or placebo (control group: n=30). Aborthion rate will be determined after 16-wk intervention. Fasting blood samples will be taken at baseline and after 16-wk intervention to measure inflammatory factor and biomarkers of oxidative stress. Start and End Date of Intervention: 16 weeks (March 20, 2015-July 21, 2015). Outcomes: Inflammatory factors and biomarkers of oxidative stress will be measured at baseline and end-of-trial.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر روی پیشگیری سقط جنین، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو در زنان باردار مبتلا به سقط خودبخودی است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور. معیار ورود و خروج مطالعه: زنان باردار 40-18 ساله مبتلا به سقط خودبخودی، در این مطالعه وارد خواهند شد. استفاده از درمان های جایگزین از قبیل هورمون یا مکمل ویتامینی و همچنین آن هایی که مبتلا به پری اکلامسی، استراحت مطلق، مرگ جنینی داخل رحمی، جدا شدن جفت و زایمان زودرس می شوند از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 زن باردار مبتلا به سقط خودبخودی واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت کپسول 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) (گروه مداخله: 30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. میزان سقط جنین، 16 هفته بعد از مداخله تعیین خواهد شد. نمونه خون ناشتا در ابتدای مطالعه و 16 هفته بعد از مداخله برای تعیین فاکتورهای التهابی و بیومارکرهای استرس اکسیداتیو از بیماران گرفته خواهد شد. زمان مداخله: 16 هفته (از 29 اسفند 1393 تا 29 تیر 1394). پيامدها: 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 inflammatory factors and biomarkers of oxidative stress in pregnant women.
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    هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر روی فاکتور التهابی و بیومارکرهای استرس اکسیداتیو در زنان باردار است.
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    Study design: Double-blind randomized controlled clinical trial.
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    طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور.
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    Population and sample size: 60 pregnant women of eligible and referred to gynecology clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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    حجم نمونه و جمعیت مورد مطالعه: 60 زن باردار واجد شرایط و ارجاع شده به کلینیک زنان و زایمان وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
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    Inclusion criteria: Pregnant women aged 18-37 years will be included in this study. Exclusion criteria: Pregnant women with a recognized cause of recurrent miscarriages or a structural uterine abnormality, history of rheumatoid arthritis, thyroid and parathyroid, adrenal diseases, hepatic or renal failure.
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    معیار ورود مطالعه: زنان باردار 37-18 ساله، در این مطالعه وارد خواهند شد. معیار خروج مطالعه: زنان باردار با علت شناخته شده از سقط مکرر یا یک ناهنجاری ساختاری رحم، سابقه آرتریت روماتوئید، تیروئید و پاراتیروئید، بیماری آدرنال، نارسایی کلیوی و کبدی.
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    Intervention: Patients will be assigned to receive either probiotic supplement containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei(2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g) (intervention group: n=30) or placebo (control group: n=30).
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    مداخله مورد مطالعه: بیماران برای دریافت کپسول 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) (گروه مداخله: 30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد.
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    Outcomes: Insulin and insulin resistance (primary outcomes) and biomarkers of oxidative stress, lipid and inflammation (secondary outcomes) will be quantified at study baseline and end-of-trial.
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    پيامدها: انسولین و مقاومت به انسولین (پیامدهای اولیه) و بیومارکرهای استرس اکسیداتیو، لیپیدی و التهابی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

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    2015-03-14, 1393/12/23
    2015-03-02, 1393/12/11
    2015-03-19, 1393/12/28
    2015-03-31, 1394/01/11
    Effect of probiotic in the prevention of spontaneously abortion
    Effect of probiotic in the treatment of pregnant women
    اثر پروبیوتیک در پیشگیری از سقط خودبخودی
    اثر پروبیوتیک در درمان زنان باردار
    Effects of probiotic supplementation on preventing abortion,inflammatory factors and biomarkers of oxidative stress in women with spontaneously abortion history
    Effects of probiotic supplementation on inflammatory factors and biomarkers of oxidative stress in
    بررسی تاثیر مکمل یاری پروبیوتیک بر پیشگیری از سقط، فاکتورهای التهابی و بیومارکرهای استرس اکسیداتیو در زنان باردار با سابقه سقط خودبخودی
    بررسی تاثیر مکمل یاری پروبیوتیک بر فاکتورهای التهابی و بیومارکرهای استرس اکسیداتیو در زنان باردار
    Pregnant women aged 18-37 years
    زنان باردار 37-18 ساله
    Pregnant women with a recognized cause of recurrent miscarriages or a structural uterine abnormality
    History of rheumatoid arthritis, thyroid and parathyroid
    Adrenal diseases
    Hepatic or renal failure.
    زنان باردار با علت شناخته شده از سقط مکرر یا یک ناهنجاری ساختاری رحم
    سابقه آرتریت روماتوئید، تیروئید و پاراتیروئید
    بیماری آدرنال
    نارسایی کلیوی و کبدی
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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 probiotic supplements (n=30) or the standard diet (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 پروبیوتیک (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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  • Health conditions studied

    #1
    N96
    Z34.-
    Habitual aborter
    Normal pregnancy
    Spontaneously abortion
    Pregnancy
    سقط خودبخودی
    بارداری

  • Primary outcomes

    #1
    Abortion rate
    Insulin
    میزان سقط
    انسولین
    20 weeks of gestation
    Baseline and End-of-trial
    هفته بیست بارداری
    ابتدا و انتهای مداخله
    Sonography
    Elisa kit
    سونوگرافی
    کیت الایزا
    #2
    Hs-CRP
    Insulin resistance
    پروتئین واکنشگر C با حساسیت بالا
    مقاومت به انسولین
    Elisa
    Elisa kit
    الایزا
    کیت الایزا
    #3
    Total antioxidant capacity
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    ظرفتیت آنتی اکسیدانی توتال
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #4
    Nitric oxide
    empty
    نیتریک اکساید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #5
    Glutathione
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    گلوتاتیون
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty

  • Secondary outcomes

    #1
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    Fasting blood sugar
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    قند خون ناشتا
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #2
    empty
    Triglycerides
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    تری گلیسرید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #3
    empty
    HDL-cholesterol
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    کلسترول HDL
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #4
    empty
    Total cholesterol
    empty
    کلسترول تام
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #5
    empty
    VLDL
    empty
    VLDL
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #6
    empty
    LDL
    empty
    LDL
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #7
    empty
    Total Antioxidant Capacity
    empty
    ظرفیت توتال آنتی اکسیدان
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #8
    empty
    Glutathione
    empty
    گلوتاتیون
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #9
    empty
    Hs-CRP
    empty
    Hs-CRP
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Elisa kit
    empty
    کیت الایزا
    #10
    empty
    Malondialdehyde
    empty
    مالون دی آلدئید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #11
    empty
    Nitric oxide
    empty
    نیتریک اکساید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری

  • Intervention groups

    #1
    Intervention group: Probiotic capsule 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 16 weeks orally.
    Intervention group: Probiotic capsule 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.
    گروه مداخله: کپسول 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 16 هفته.
    گروه مداخله: کپسول 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.
    #2
    Control group: Placebo capsule, daily, for 16 weeks orally.
    Control group: Placebo capsule, daily, for 12 weeks orally.
    گروه کنترل: کپسول پلاسبو، روزانه، به صورت خوراکی برای 16 هفته.
    گروه کنترل: کپسول پلاسبو، روزانه، به صورت خوراکی برای 12 هفته.

  • Recruitment centers

    #1
    Name of recruitment center - English: Kossar Clinic
    Name of recruitment center - Persian: کلینیک کوثر
    Full name of responsible person - English: Mehri Jamilian
    Full name of responsible person - Persian: مهری جمیلیان
    Street address - English:
    Street address - Persian:
    City - English: Arak
    City - Persian: اراک
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Gynecology Clinic
    Name of recruitment center - Persian: کلینیک زنان و زایمان
    Full name of responsible person - English: Mehri Jamilian
    Full name of responsible person - Persian: مهری جمیلیان
    Street address - English: Emam Khomeyni Avenue, Arak
    Street address - Persian: اراک، خیابان امام خمینی
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3848176941
    Phone: +98 84 3223 3823
    Fax:
    Email: research@arakmu.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Arak University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
    Full name of responsible person - English: Mehri Jamilian
    Full name of responsible person - Persian: مهری جمیلیان
    Street address - English: Vice-chancellor for Education and Research, Sardasht Avenue, Arak
    Street address - Persian: اراك، خیابان سردشت، معاونت آموزش و تحقيقات
    City - English: Arak
    City - Persian: اراک
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Arak University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
    Full name of responsible person - English: Mehri Jamilian
    Full name of responsible person - Persian: مهری جمیلیان
    Street address - English: Vice-chancellor for Education and Research, Sardasht Avenue, Arak
    Street address - Persian: اراك، خیابان سردشت، معاونت آموزش و تحقيقات
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3848176941
    Phone: +98 86 3417 3639
    Fax:
    Email: research@arakmu.ac.ir
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    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:
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    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: 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_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: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: Nutrition PhD
    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: Bolvare Ghotbe Ravandi, 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: Nutrition PhD
    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: Bolvare Ghotbe Ravandi, 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_z@kaums.ac.ir
    Web page address:

  • Person responsible for updating data

    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:
    Position - Persian:
    Latest degree:
    Area of specialty/work: 0
    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: 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: 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_z@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 inflammatory factors and biomarkers of oxidative stress in pregnant women.
Design
Study design: Double-blind randomized controlled clinical trial.
Settings and conduct
Population and sample size: 60 pregnant women of eligible and referred to gynecology clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women aged 18-37 years will be included in this study. Exclusion criteria: Pregnant women with a recognized cause of recurrent miscarriages or a structural uterine abnormality, history of rheumatoid arthritis, thyroid and parathyroid, adrenal diseases, hepatic or renal failure.
Intervention groups
Intervention: Patients will be assigned to receive either probiotic supplement containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei(2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g) (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Outcomes: Insulin and insulin resistance (primary outcomes) and biomarkers of oxidative stress, lipid and inflammation (secondary outcomes) will be quantified at study baseline and end-of-trial.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201503035623N38
Registration date: 2015-03-10, 1393/12/19
Registration timing: registered_while_recruiting

Last update: 2019-10-04, 1398/07/12
Update count: 1
Registration date
2015-03-10, 1393/12/19
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
Arak University of Medical Sciences
Expected recruitment start date
2015-03-02, 1393/12/11
Expected recruitment end date
2015-03-31, 1394/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of probiotic supplementation on inflammatory factors and biomarkers of oxidative stress in
Public title
Effect of probiotic in the treatment of pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 18-37 years
Exclusion criteria:
Pregnant women with a recognized cause of recurrent miscarriages or a structural uterine abnormality History of rheumatoid arthritis, thyroid and parathyroid Adrenal diseases Hepatic or renal failure.
Age
From 18 years old to 37 years old
Gender
Female
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 probiotic supplements (n=30) or the standard diet (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
Arak University of Medical Sciences
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2014-09-08, 1393/06/17
Ethics committee reference number
19-167-93

Health conditions studied

1

Description of health condition studied
Pregnancy
ICD-10 code
Z34.-
ICD-10 code description
Normal pregnancy

Primary outcomes

1

Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa kit

2

Description
Insulin resistance
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa kit

Secondary outcomes

1

Description
Fasting blood sugar
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

2

Description
Triglycerides
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

3

Description
HDL-cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

4

Description
Total cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

5

Description
VLDL
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

6

Description
LDL
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

7

Description
Total Antioxidant Capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

8

Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

9

Description
Hs-CRP
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa kit

10

Description
Malondialdehyde
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

11

Description
Nitric oxide
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

Intervention groups

1

Description
Intervention group: Probiotic capsule 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 capsule, daily, for 12 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gynecology Clinic
Full name of responsible person
Mehri Jamilian
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 84 3223 3823
Email
research@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
8115187159
Phone
+98 31 5546 3378
Email
asemi_z@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
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
8115187159
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
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