Clinical trial of the effect of combined probiotic and selenium supplementation compared with the placebo on hormonal profiles, inflammatory factors and oxidative stress biomarkers in women with polycystic ovary syndrome
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Protocol summary
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: عدم تمایل به همکاری.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: بارداری، هیپرپلازی آدرنال، تومورهای ترشح کننده آندروژن، هیپرپرولاکتینمیا، اختلال در عملکرد تیروئید، دیابت.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: عدم تمایل به همکاریبارداری، هیپرپلازی آدرنال، تومورهای ترشح کننده آندروژن، هیپرپرولاکتینمیا، اختلال در عملکرد تیروئید، دیابت.
معیار خروج از مطالعه: بارداری
هیپرپلازی آدرنال
تومورهای ترشح کننده آندروژن
هیپرپرولاکتینمیا
اختلال در عملکرد تیروئید
دیابت
معیار خروج از مطالعه: عدم تمایل به همکاری.بارداری هیپرپلازی آدرنال تومورهای ترشح کننده آندروژن هیپرپرولاکتینمیا اختلال در عملکرد تیروئید دیابت
At study baseline and after stratification for pre-intervention BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y), subjects will be randomly divided into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
At study baseline, after balanced blocked randomisation, subjects will be allocated into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
At study baseline and, after stratification for pre-intervention BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y)balanced blocked randomisation, subjects will be randomly dividedallocated into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی (<25 و ≥25 کیلوگرم بر متر مربع) و سن (<30 و ≥30)، افراد به طور تصادفی برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه، بعد از تصادفی سازی بلوکی بالانس شده، افراد برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه و، بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی (<25 و ≥25 کیلوگرم بر متر مربع) و سن (<30 و ≥30)تصادفی سازی بلوکی بالانس شده، افراد به طور تصادفی برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
Secondary outcomes
#1
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Beck depression inventory
Beck depression inventory
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پرسشنامه اضطراب بک
پرسشنامه اضطراب بک
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Questionnaire
Questionnaire
empty
پرسشنامه
پرسشنامه
#2
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Depression anxiety and stress scale
Depression anxiety and stress scale
empty
امتیاز استرس، اضطراب افسردگی
امتیاز استرس، اضطراب افسردگی
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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
empty
Questionnaire
Questionnaire
empty
پرسشنامه
پرسشنامه
#3
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General health questionnaire
General health questionnaire
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پرسشنامه سلامت عمومی
پرسشنامه سلامت عمومی
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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
Questionnaire
Questionnaire
empty
پرسشنامه
پرسشنامه
#4
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Modified Ferriman Gallwey
Modified Ferriman Gallwey
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فری من گال وی تعدیل شده
فری من گال وی تعدیل شده
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Questionnaire
Questionnaire
empty
پرسشنامه
پرسشنامه
Sharing plan
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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.
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هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست.
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 combined probiotic and selenium supplementation on hormonal profiles, inflammatory factors and oxidative stress biomarkers in patients with polycystic ovary syndrome.
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 combined probiotic and selenium supplement (n=30) or placebo (n=30).
Settings and conduct
Among patients with polycystic ovary syndrome referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 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. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate.
Intervention groups
Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and selenium supplements (Webber Naturals, Mississauga, Canada), 200 µg, daily, for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily for 12 weeks orally.
Main outcome variables
Outcomes: Total testosterone (primary outcome) and biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N22
Registration date:2017-12-18, 1396/09/27
Registration timing:registered_while_recruiting
Last update:2019-09-16, 1398/06/25
Update count:1
Registration date
2017-12-18, 1396/09/27
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-04, 1396/09/13
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined probiotic and selenium supplementation compared with the placebo on hormonal profiles, inflammatory factors and oxidative stress biomarkers in women with polycystic ovary syndrome
Public title
Effect of combined probiotic and selenium supplementation in treatment of patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients with polycystic ovary syndrome.
Individuals aged 18 to 40 years.
At study baseline, after balanced blocked randomisation, subjects will be allocated into two groups to receive supplement or placebo. 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 Arak University of Medical Sciences
Street address
Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2017-12-03, 1396/09/12
Ethics committee reference number
IR.ARAKMU.REC.1396.203
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Total testosterone
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
SHBG
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
3
Description
Nitric oxide
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
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Beck depression inventory
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
8
Description
Depression anxiety and stress scale
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
9
Description
General health questionnaire
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
10
Description
Modified Ferriman Gallwey
Timepoint
At the beginning of the study and after 12 weeks of intervention