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Protocol summary
Objective: The aim of this study is to determine the effects of probiotic supplementation on hormonal profiles and biomarkers of oxidative stress in patients with polycystic ovary syndrome. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with polycystic ovary syndrome referred to Akbarabadi Clinic affiliated to Iran University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive probiotic (n=30) or placebo (n=30) per day. Probiotic and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Hormonal profiles (primary outcome) and biomarkers of oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
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Objective: The aim of this study is to determine the effects of probiotic supplementation on hormonal profiles and biomarkers of oxidative stress in patients with polycystic ovary syndrome. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with polycystic ovary syndrome referred to Akbarabadi Clinic affiliated to Iran University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive probiotic (n=30) or placebo (n=30) per day. Probiotic and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Hormonal profiles (primary outcome) and biomarkers of oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر پروفایل های هورمونی و بیمارکرهای استرس اکسیداتیو در بیماران مبتلا به سندروم تخمدان پلی کیستیک است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک اکبرآبادی وابسته به دانشگاه علوم پزشکی ایران، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت پروبیوتیک (30=n) یا پلاسبو (30=n) روزانه اختصاص داده خواهند شد. کپسول های پروبیوتیک و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: پروفایل های هورمونی (پیامد اولیه) و بیومارکرهای استرس اکسیداتیو (پیامد ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر پروفایل های هورمونی و بیمارکرهای استرس اکسیداتیو در بیماران مبتلا به سندروم تخمدان پلی کیستیک است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک اکبرآبادی وابسته به دانشگاه علوم پزشکی ایران، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت پروبیوتیک (30=n) یا پلاسبو (30=n) روزانه اختصاص داده خواهند شد. کپسول های پروبیوتیک و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: پروفایل های هورمونی (پیامد اولیه) و بیومارکرهای استرس اکسیداتیو (پیامد ثانویه) 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 hormonal profiles and biomarkers of oxidative stress in patients with polycystic ovary syndrome.
The aim of this study is to determine the effects of probiotic supplementation on hormonal profiles and biomarkers of oxidative stress in patients with polycystic ovary syndrome.
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هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر پروفایل های هورمونی و بیمارکرهای استرس اکسیداتیو در بیماران مبتلا به سندروم تخمدان پلی کیستیک است.
هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر پروفایل های هورمونی و بیمارکرهای استرس اکسیداتیو در بیماران مبتلا به سندروم تخمدان پلی کیستیک است.
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Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
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طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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Population and sample size: Among patients with polycystic ovary syndrome referred to Akbarabadi Clinic affiliated to Iran University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
Population and sample size: Among patients with polycystic ovary syndrome referred to Akbarabadi Clinic affiliated to Iran University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
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حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک اکبرآبادی وابسته به دانشگاه علوم پزشکی ایران، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک اکبرآبادی وابسته به دانشگاه علوم پزشکی ایران، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
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Inclusion criteria: Patients with PCOS according to Rotterdam criteria and aged 18 to 40 years will be included in this study. Exclusion criteria: Smokers, taking probiotic supplements, pregnant women, endocrine diseases including thyroid, diabetes and/or impaired glucose tolerance
Inclusion criteria: Patients with PCOS according to Rotterdam criteria and aged 18 to 40 years will be included in this study. Exclusion criteria: Smokers, taking probiotic supplements, pregnant women, endocrine diseases including thyroid, diabetes and/or impaired glucose tolerance
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معیار ورود به مطالعه: بیماران مبتلا به سندرم تخمدان پلی کیستیک بر اساس معیار روتردام و در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: افراد سیگاری، مصرف مکمل های پروبیوتیک، زنان باردار، بیماری های اندوکرین از جمله تیروئید، دیابت یا اختلال در تحمل گلوکز.
معیار ورود به مطالعه: بیماران مبتلا به سندرم تخمدان پلی کیستیک بر اساس معیار روتردام و در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: افراد سیگاری، مصرف مکمل های پروبیوتیک، زنان باردار، بیماری های اندوکرین از جمله تیروئید، دیابت یا اختلال در تحمل گلوکز.
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Intervention: Patients will be assigned into two groups to receive probiotic (n=30) or placebo (n=30) per day. Probiotic and placebos capsules are similar in shape and size.
Intervention: Patients will be assigned into two groups to receive probiotic (n=30) or placebo (n=30) per day. Probiotic and placebos capsules are similar in shape and size.
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مداخله مورد مطالعه: بیماران به دو گروه برای دریافت پروبیوتیک (30=n) یا پلاسبو (30=n) روزانه اختصاص داده خواهند شد. کپسول های پروبیوتیک و پلاسبو از نظر شکل و اندازه مشابه هستند.
مداخله مورد مطالعه: بیماران به دو گروه برای دریافت پروبیوتیک (30=n) یا پلاسبو (30=n) روزانه اختصاص داده خواهند شد. کپسول های پروبیوتیک و پلاسبو از نظر شکل و اندازه مشابه هستند.
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Outcomes: Hs-CRP (primary outcome) and nitric oxide (NO), biomarkers of oxidative stress and hormonal profile (secondary outcome) will be quantified at study baseline and end-of-trial.
Outcomes: Hs-CRP (primary outcome) and nitric oxide (NO), biomarkers of oxidative stress and hormonal profile (secondary outcome) will be quantified at study baseline and end-of-trial.
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پيامدها: پروتئین واکنشگر C با حساسیت بالا (پیامد اولیه) و نیتریک اکساید، بیومارکرهای استرس اکسیداتیو و پروفایل های هورمونی (پیامد ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: پروتئین واکنشگر C با حساسیت بالا (پیامد اولیه) و نیتریک اکساید، بیومارکرهای استرس اکسیداتیو و پروفایل های هورمونی (پیامد ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in women with polycystic ovary syndrome
Clinical trial of the effect of probiotic supplementation compared with the placebo on profiles of metabolic in women with polycystic ovary syndrome
Clinical trial of the effect of probiotic supplementation compared with the placebo on profiles of metabolic profiles in women with polycystic ovary syndrome
Patients with PCOS according to Rotterdam criteria
Aged 18 to 40 years
Obtaining informed consent
Patients with PCOS according to Rotterdam criteria Aged 18 to 40 years Obtaining informed consent
بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام
در محدوده سنی 18 تا 40 سال
دریافت رضایت آگاهانه از بیماران
بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام در محدوده سنی 18 تا 40 سال دریافت رضایت آگاهانه از بیماران
Smokers
Taking probiotic supplements
Pregnant women
Endocrine diseases including thyroid, diabetes and/or impaired glucose tolerance.
Smokers Taking probiotic supplements Pregnant women Endocrine diseases including thyroid, diabetes and/or impaired glucose tolerance.
افراد سیگاری
مصرف مکمل های پروبیوتیک
زنان باردار
بیماری های اندوکرین از جمله تیروئید، دیابت یا اختلال در تحمل گلوکز
افراد سیگاری مصرف مکمل های پروبیوتیک زنان باردار بیماری های اندوکرین از جمله تیروئید، دیابت یا اختلال در تحمل گلوکز
Randomization will be done by the use of computer-generated random numbers.
Randomization will be done by the use of computer-generated random numbers.
تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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Randomization will be done by the use of computer-generated random numbers.
Randomization will be done by the use of computer-generated random numbers.
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تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
تصادفی سازی با استفاده از جدول 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.
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.
شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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Primary outcomes
#1
Total testosterone
hs-CRP
Total testosteronehs-CRP
توتال تستوسترون
پروتئین واکنشگر C با حساسیت بالا
توتال تستوسترونپروتئین واکنشگر C با حساسیت بالا
#2
SHBG
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SHBG
SHBG
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SHBG
At the beginning of the study and after 12 weeks of intervention
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At the beginning of the study and after 12 weeks of intervention
در ابتدای مطالعه و 12 هفته بعد از مداخله
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در ابتدای مطالعه و 12 هفته بعد از مداخله
Elisa kit
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Elisa kit
کیت الایزا
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کیت الایزا
Secondary outcomes
#1
Total antioxidant
Nitric oxide
Total antioxidantNitric oxide
توتال آنتی اکسیدانت
نیتریک اکساید
توتال آنتی اکسیدانتنیتریک اکساید
اسکتروفتومتری
اسپکتروفتومتری
اسکتروفتومتریاسپکتروفتومتری
#2
Malondialdehyde
Total antioxidant capacity
MalondialdehydeTotal antioxidant capacity
مالون دی آلدئید
ظرفیت آنتی اکسیدانی توتال
مالون دی آلدئیدظرفیت آنتی اکسیدانی توتال
اسکتروفتومتری
اسپکتروفتومتری
اسکتروفتومتریاسپکتروفتومتری
#3
اسکتروفتومتری
اسپکتروفتومتری
اسکتروفتومتریاسپکتروفتومتری
#4
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Malondialdehyde
Malondialdehyde
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مالون دی آلدئید
مالون دی آلدئید
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Spectrophotometry
Spectrophotometry
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اسپکتروفتومتری
اسپکتروفتومتری
#5
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Total testosterone
Total testosterone
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توتال تستوسترون
توتال تستوسترون
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Elisa kit
Elisa kit
empty
کیت الایزا
کیت الایزا
#6
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SHBG
SHBG
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SHBG
SHBG
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Elisa kit
Elisa kit
empty
کیت الایزا
کیت الایزا
#7
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DHEAS
DHEAS
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DHEAS
DHEAS
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Elisa kit
Elisa kit
empty
کیت الایزا
کیت الایزا
#8
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Hirsutism
Hirsutism
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Hirsutism
Hirsutism
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Clinical observation
Clinical observation
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مشاهده بالینی
مشاهده بالینی
Recruitment centers
#1
Name of recruitment center - English: Akbarabadi Clinic
Name of recruitment center - Persian: کلینیک اکبرآبادی
Full name of responsible person - English: Maryam Karamali
Full name of responsible person - Persian: مریم کرمعلی
Street address - English: Akbarabadi Hospital, Mowlavi Street, Tehran
Street address - Persian: تهران، خیابان مولوی، بیمارستان اکبرآبادی
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Akbarabadi clinic
Name of recruitment center - Persian: کلینیک اکبرآبادی
Full name of responsible person - English: Maryam Karamali
Full name of responsible person - Persian: مریم کرمعلی
Street address - English: Akbarabadi Hospital, Mowlavi Street, Tehran
Street address - Persian: تهران، خیابان مولوی، بیمارستان اکبرآبادی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 5560 6034
Fax:
Email: dr.karamali@arakmu.ac.ir
Web page address:
Name of recruitment center - English: Akbarabadi Clinicclinic Name of recruitment center - Persian: کلینیک اکبرآبادی Full name of responsible person - English: Maryam Karamali Full name of responsible person - Persian: مریم کرمعلی Street address - English: Akbarabadi Hospital, Mowlavi Street, Tehran Street address - Persian: تهران، خیابان مولوی، بیمارستان اکبرآبادی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 5560 6034 Fax: Email: dr.karamali@arakmu.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Iran University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Seyed Ali Javad Moosavi
Full name of responsible person - Persian: سيد علي جواد موسوي
Street address - English: Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
Street address - Persian: تهران، بزرگراه همت، معاونت پژوهشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
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, Iran University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Seyed Ali Javad Moosavi
Full name of responsible person - Persian: سيد علي جواد موسوي
Street address - English: Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
Street address - Persian: تهران، بزرگراه همت، معاونت پژوهشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 4465 9771
Fax:
Email: dr_moosavi_pul@yahoo.ca
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Iran University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران Full name of responsible person - English: Seyed Ali Javad Moosavi Full name of responsible person - Persian: سيد علي جواد موسوي Street address - English: Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran Street address - Persian: تهران، بزرگراه همت، معاونت پژوهشی دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 4465 9771 Fax: Email: dr_moosavi_pul@yahoo.ca Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Iran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Maryam Karamali
Full name of responsible person - Persian: مریم کرمعلی
Position - English: Gynecologist
Position - Persian: متخصص زنان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Akbarabadi Hospital, Mowlavi Street, Tehran
Street address - Persian: تهران، خیابان مولوی، بیمارستان اکبرآبادی
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 5560 6034
Mobile: 00
Fax:
Email: karamali.maryam2@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Iran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Maryam Karamali
Full name of responsible person - Persian: مریم کرمعلی
Position - English: Gynecologist
Position - Persian: متخصص زنان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Akbarabadi Hospital, Mowlavi Street, Tehran
Street address - Persian: تهران، خیابان مولوی، بیمارستان اکبرآبادی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9819693345
Phone: +98 86 1278 0660
Mobile: 00
Fax:
Email: karamali.maryam2@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Iran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران Full name of responsible person - English: Maryam Karamali Full name of responsible person - Persian: مریم کرمعلی Position - English: Gynecologist Position - Persian: متخصص زنان Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Akbarabadi Hospital, Mowlavi Street, Tehran Street address - Persian: تهران، خیابان مولوی، بیمارستان اکبرآبادی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9819693345 Phone: +98 21 5560 603486 1278 0660 Mobile: 00 Fax: Email: karamali.maryam2@gmail.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: 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: 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: 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:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: PhD of Nutrition Position - Persian: دکتری تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Mobile: 00+98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: 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: 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:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: PhD of Nutrition Position - Persian: دکتری تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Mobile: 00+98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
Undecided - It is not yet known if there will be a plan to make this available
Undecided - It is not yet known if there will be a plan to make this available
empty
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
Protocol summary
Study aim
The aim of this study is to determine the effects of probiotic supplementation on hormonal profiles and biomarkers of oxidative stress in patients with polycystic ovary syndrome.
Design
Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
Settings and conduct
Population and sample size: Among patients with polycystic ovary syndrome referred to Akbarabadi Clinic affiliated to Iran University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with PCOS according to Rotterdam criteria and aged 18 to 40 years will be included in this study. Exclusion criteria: Smokers, taking probiotic supplements, pregnant women, endocrine diseases including thyroid, diabetes and/or impaired glucose tolerance
Intervention groups
Intervention: Patients will be assigned into two groups to receive probiotic (n=30) or placebo (n=30) per day. Probiotic and placebos capsules are similar in shape and size.
Main outcome variables
Outcomes: Hs-CRP (primary outcome) and nitric oxide (NO), biomarkers of oxidative stress and hormonal profile (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201704235623N112
Registration date:2017-04-27, 1396/02/07
Registration timing:retrospective
Last update:2019-09-23, 1398/07/01
Update count:1
Registration date
2017-04-27, 1396/02/07
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, Iran University of Medical Sciences
Expected recruitment start date
2017-02-28, 1395/12/10
Expected recruitment end date
2017-03-30, 1396/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of probiotic supplementation compared with the placebo on profiles of metabolic in women with polycystic ovary syndrome
Public title
Effect of supplementation in treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with PCOS according to Rotterdam criteria
Aged 18 to 40 years
Obtaining informed consent
Exclusion criteria:
Smokers
Taking probiotic supplements
Pregnant women
Endocrine diseases including thyroid, diabetes and/or impaired glucose tolerance.
Age
From 18 years old to 40 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
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 Iran University of Medical Sciences
Street address
Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-02-27, 1395/12/09
Ethics committee reference number
IR.IUMS.REC.1395.8823215264
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Total testosterone
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
6
Description
SHBG
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
7
Description
DHEAS
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
8
Description
Hirsutism
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Clinical observation
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) (Tak Gen Zist, Tehran, Iran), daily, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi clinic
Full name of responsible person
Maryam Karamali
Street address
Akbarabadi Hospital, Mowlavi Street, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 5560 6034
Email
dr.karamali@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 4465 9771
Email
dr_moosavi_pul@yahoo.ca
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Karamali
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Akbarabadi Hospital, Mowlavi Street, Tehran
City
Tehran
Province
Tehran
Postal code
9819693345
Phone
+98 86 1278 0660
Fax
Email
karamali.maryam2@gmail.com
Web page address
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_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