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The effect of probiotic capsule supplementation on severity depression among patients with major depressive disorder under treatment with citalopram

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History
# Registration date Revision Id
2 2020-09-26, 1399/07/05 154487
1 2014-11-04, 1393/08/13 16421
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  • Protocol summary

    The aim of this study is to determine the effect of probiotic capsule supplementation on severity depression among patients with major depressive disorder under treatment with citalopram. Study design: Randomized double-blinded controlled clinical trial. Inclusion Criteria: Patients with major depressive according to DSM-IV-TR criteria, aged 20 to50 years, the least score 12 on BDI –II scoring system. Exclusion Criteria: Pregnancy, alcohol and drug abuse within 6 months prior to the start of the project, psychosis, mental retardation, depression caused by physical illness or drugs and substances, any type of severe, chronic physical illness, chronic physical illness and any extreme and severe mental disorders (suicidal ideation, psychotic symptoms, symptoms of manic phase, etc) will be excluded. Population and sample size: 70 patients with major depressive disorder of eligible and referred to Karganejad hospital to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either the probiotic capsule (intervention group: n=35) or placebo capsule (control group: n=35). Fasting blood samples will be taken at baseline and after 8-wk intervention. Intervention: 8 weeks (July 12, 2014-september 12, 2014). Outcomes: Fasting plasma glucose, serum insulin, hs-CRP, insulin resistance, lipid profiles (total cholesterol, HDL-cholesterol and triglycerides) will be measured at the beginning and end of the intervention.
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    هدف این مطالعه تعیین اثر كمكي كپسول پروبیوتیک بر شدت افسردگی در بیماران مبتلا به اختلال افسردگی اساسی تحت درمان با سیتالوپرام است. طراحي انجام مطالعه:کارآزمایی بالینی تصادفي دوسوكور. معیارهای ورود به مطالعه: بیماران مبتلا به اختلال افسردگی اساسی بر اساس کرایتریای DSM-IV-TR، در محدوده سنی50-20سال و امتیاز حداقل 12در سیستم امتیاز دهی BDI -II وارد مطالعه خواهند شد. معیارهای خروج از مطالعه: بارداری، مصرف الکل و سوء مصرف مواد طی 6 ماه قبل از شروع طرح، علائم سایکوز، عقب ماندگی ذهنی، افسردگی ناشی از بیماری های جسمی یا مصرف داروها و مواد، هر نوع بیماری های جسمی شدید و مزمن، ابتلا به بیماری طبی حاد و شدید و بروز هرگونه اختلال شدید روانی (افکارخودکشی، علائم سایکوتیک، علائم فاز مانیا و...) از مطالعه حذف خواهند شد. حجم نمونه و جمعیت مورد مطالعه:70 بیمار مبتلا به اختلال افسردگی اساسی واجد شرایط و ارجاع شده به بیمارستان کارگرنژاد وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهندشد. مداخله مورد مطالعه: بیماران برای دریافت یا کپسول پروبیوتیک (گروه مداخله: 35= n)یا کپسول پلاسبو (گروه کنترل:35=n) تقسیم خواهندشد. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته (از 21 تیر 1393 تا 21 شهریور1393). پيامدها: گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین، hs-CRP، مقاومت به انسولين، پروفایل های لیپیدی (توتال کلسترول،کلسترول HDL و تری گلیسرید) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    The aim of this study is to determine the effect of probiotic capsule supplementation on severity depression among patients with major depressive disorder under treatment with citalopram.
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    هدف این مطالعه تعیین اثر كمكي كپسول پروبیوتیک بر شدت افسردگی در بیماران مبتلا به اختلال افسردگی اساسی تحت درمان با سیتالوپرام است.
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    Among patients with major depressive referred to the Kargarneghad Clinic affiliated to Kashan Medical Sciences University, Kashan, Iran, 40 patients will be selected. The study will be double blind in which participants and investigators/the assessors of the outcomes are unaware of the study groups and drug and placebo are similar. Fasting blood samples will be taken at baseline and end of the intervention. Intervention period: 8 weeks.
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    از بین بیماران مبتلا به افسردگی ماژور ارجاع شده به کلینیک کارگرنژاد وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران، 40 بیمار انتخاب خواهند شد. این مطالعه به صورت دوسویه کور است و هم شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروه های مطالعه بی اطلاعند. مکمل ها و پلاسبو مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و انتهای مداخله از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته.
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    40 patients with major depressive disorder of eligible and referred to Karganejad hospital to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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    40 بیمار مبتلا به اختلال افسردگی اساسی واجد شرایط و ارجاع شده به بیمارستان کارگرنژاد وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهندشد.
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    Inclusion criteria: Patients with major depressive, aged between 20 to 55 years. Exclusion criteria: Age <20 y or >55 y; a history of coronary infarction, angina pectoris, pregnancy or lactation, substance abuse; taking dietary supplements or probiotic supplements during the previous 2 months
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    معیار ورود: بیماران مبتلا به افسردگی ماژور، سن بین 20 تا 55 سال. معیار خروج: سن کمتر از 20 و بیشتر از 55 سال، سابقه سکته قلبی، آنژین سینه ای، بارداری یا شیردهی، مصرف مواد مخدر، گرفتن مکمل رژیمی یا پروبیوتیک در طول دوران دو ماه گذشته
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    Patients will be assigned to receive either the probiotic capsule (intervention group: n=20) or placebo capsule (control group: n=20).
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    بیماران برای دریافت یا کپسول پروبیوتیک (گروه مداخله: 20= n)یا کپسول پلاسبو (گروه کنترل:20=n) تقسیم خواهندشد.
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    Beck Depression Inventory (primary outcome), and glycemic control, lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes)
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    پرسشنامه افسردگی بک (پیامد اولیه) و گلیسمیک کنترل، پروفایل لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامدهای ثانویه)

  • General information

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    70
    40
    2014-07-12, 1393/04/21
    2014-07-01, 1393/04/10
    2014-09-12, 1393/06/21
    2014-07-15, 1393/04/24
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    Due to an error, the request for an update in our website has 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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    بواسطه کم توجهی، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شده است. اگرچه، اصلاحات صورت گرفته مطابق با یا پروپوزال اصلی تصویب شده یا با هماهنگی معاونت پژوهشی دانشگاه بود.
    Patients with major depressive
    Aged between 20 to 55 years
    بیماران مبتلا به افسردگی ماژور
    سن بین 20 تا 55 سال
    Age <20 y or >55 years
    A history of coronary infarction
    Angina pectoris
    Pregnancy or lactation
    Substance abuse
    Taking dietary supplements or probiotic supplements during the previous 2 months
    سن کمتر از 20 و بیشتر از 55 سال
    سابقه سکته قلبی
    آنژین سینه ای
    بارداری یا شیردهی
    مصرف مواد مخدر
    گرفتن مکمل رژیمی یا پروبیوتیک در طول دوران دو ماه گذشته
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    Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 40 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.
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    بیماران به طور تصادفی به دو گروه تخصیص داده خواهند شد. یک لیست اعداد تصادفی از 1 تا 40 با استفاده از یک سایت تولید کننده اعداد تصادفی (https://stattrek.com/statistics/random-number-generator.aspx) ایجاد خواهد شد و سپس بیماران با استفاده از اعداد به دو گروه مداخله تخصیص داده خواهند شد. روش تصادفی سازی بلوکی با نسبت 1 به 1 برای رسیدن به دو گروه با حجم نمونه برابر استفاده خواهد شد.
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    Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic, who is not involved in the trial and not aware of random sequences, will assign the participants to the numbered bottles of drugs. Supplements and placebos are in the same packaging at the Tak Gen Zist pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of intervention. After analyzing the data, pocket codes will be decoded. Participants and investigators/the assessors of the outcomes are unaware of the study groups.
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    تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده داروها را تخصیص خواهد داد. مکمل ها و پلاسبو در شرکت داروسازی تک ژن زیست در بسته بندی های مشابه قرار می گیرند و بر روی آن ها فقط کد گذاشته می شود.بیماران و محققین از نوع مداخله بی خبرند و بعد از آنالیز داده ها، کدهای بسته ها رمز گشایی میشود. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروه های مطالعه بی اطلاعند.
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  • Ethics committees

    #1
    1234
    93044

  • Primary outcomes

    #1
    Triglyceride
    Severity depression
    تری گلیسرید
    شدت افسردگی
    Baseline and End-of-trial
    At the beginning of the study and after 8 weeks of intervention
    ابتدا و انتهای مطالعه
    در ابتدای مطالعه و 8 هفته بعد از مداخله
    Enzymatic
    Questionnaire Beck
    آنزیمی
    پرسشنامه بک
    #2
    Cholesterol
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    کلسترول
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Enzymatic
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    آنزیمی
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    #3
    severity depression
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    شدت افسردگی
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    One day before the start of the intervention (first visit: Baseline study), the end of the second week (second visit of drug side effects), the end of the fourth week (third visit) and at the end of the sixth week (fourth visit) and at the end of the eighth week (End-of-trial) will visit .
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    در روز اول قبل از شروع مداخله (ویزیت اول )، پايان هفته دوم (ویزیت دوم از نظر عوارض دارویی)، پايان هفته چهارم (ویزیت سوم) و پايان هفته ششم (ویزیت چهارم) و پايان هفته هشتم ویزیت خواهند شد.
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    at each visit to the BDI-II testing will be completed.
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    در هر ويزيت برای آن ها تست BDI-IIتكميل خواهدشد
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    #4
    hs-CRP
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    پروتئین واکنشگر C با حساسیت بالا
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Elisa
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    الایزا
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    #5
    Fasting plasma glucose
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    قند خون ناشتا
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Enzymatic
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    آنزیمی
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    #6
    Insulin
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    انسولین
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Elisa
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    الایزا
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  • Secondary outcomes

    #1
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    Insulin resistance
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    مقاومت به انسولین
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    At the beginning of the study and after 8 weeks of intervention
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    در ابتدای مطالعه و 8 هفته بعد از مداخله
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    Calculation using the Homeostasis Model Assessment (HOMA) formula
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    محاسبه با استفاده از فرمول HOMA
    #2
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    Insulin
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    انسولین
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    At the beginning of the study and after 8 weeks of intervention
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    در ابتدای مطالعه و 8 هفته بعد از مداخله
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    ELISA kit
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    کیت الایزا
    #3
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    Fasting plasma glucose
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    قند خون ناشتا
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    At the beginning of the study and after 8 weeks of intervention
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    در ابتدای مطالعه و 8 هفته بعد از مداخله
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    Enzymatic kit
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    کیت آنزیمی
    #4
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    Total cholesterol
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    کلسترول تام
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    At the beginning of the study and after 8 weeks of intervention
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    در ابتدای مطالعه و 8 هفته بعد از مداخله
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    Enzymatic kit
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    کیت آنزیمی
    #5
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    Triglycerides
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    تری گلیسرید
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    At the beginning of the study and after 8 weeks of intervention
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    در ابتدای مطالعه و 8 هفته بعد از مداخله
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    Enzymatic kit
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    کیت آنزیمی
    #6
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    High-density lipoprotein (HDL)
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    کلسترول HDL
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    At the beginning of the study and after 8 weeks of intervention
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    در ابتدای مطالعه و 8 هفته بعد از مداخله
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    Enzymatic kit
    empty
    کیت آنزیمی
    #7
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    Low-density lipoprotein (LDL)
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    کلسترول LDL
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    At the beginning of the study and after 8 weeks of intervention
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    در ابتدای مطالعه و 8 هفته بعد از مداخله
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    Enzymatic kit
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    کیت آنزیمی
    #8
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    High-sensitivity C-reactive Protein (hs-CRP)
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    پروتئین واکنشگر C با حساسیت بالا
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    At the beginning of the study and after 8 weeks of intervention
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    در ابتدای مطالعه و 8 هفته بعد از مداخله
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    ELISA kit
    empty
    کیت الایزا
    #9
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    Glutathione
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    گلوتاتیون
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    At the beginning of the study and after 8 weeks of intervention
    empty
    در ابتدای مطالعه و 8 هفته بعد از مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
    #10
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    Total antioxidant capacity
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    ظرفیت آنتی اکسیدانی توتال
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    At the beginning of the study and after 8 weeks of intervention
    empty
    در ابتدای مطالعه و 8 هفته بعد از مداخله
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    Spectrophotometry
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    اسپکتروفتومتری

  • Intervention groups

    #1
    Multi species probiotic capsules containing Lactobacillus casei 2× 109 CFU, Lactobacillus acidophilus 7 × 109 CFU, Lactobacillus rhamnosus 2× 109 CFU, Lactobacillus bulgaricus 2 × 108 CFU, Bifidbacterium breve 2 × 1010 CFU, Bifidbacterium longum 7 × 109 CFU, Streptococcus thermophilus 2 × 109 CFU .
    Multi species probiotic capsules containing Lactobacillus acidophilus 2× 109 CFU, Lactobacillus casei 2× 109 CFU, Bifidbacterium bifidum 2 × 109 CFU.
    گروه مداخله: کپسول پروبیوتیک چند سویه ای حاوی لاکتوباسیلوس اسیدوفیلوس109×2CFU، لاکتوباسیلوس کازئی109×7، لاکتوباسیلوس رامنسوس109×2، لاکتوباسیلوس بولگاریکوس108×2، بیفیدوباکتریوم بیفیدوس 1010×2، بیفیوباکتریوم لانگوم 109×7 و استرپتوکوکوس ترموفیلوس 109×2.
    گروه مداخله: کپسول پروبیوتیک چند سویه ای حاوی لاکتوباسیلوس اسیدوفیلوس109 ×2CFU، لاکتوباسیلوس کازئی109×2، بیفیدوباکتریوم بیفیدوم 109×2.

  • Recruitment centers

    #1
    Name of recruitment center - English: Kargarnejad Hospital
    Name of recruitment center - Persian: بیمارستان کارگرنژاد
    Full name of responsible person - English: Dr. Zahra Kashani-Poor
    Full name of responsible person - Persian: دکتر زهرا كاشاني پور
    Street address - English: 5th of Qotb –e Ravandi Blvd, Kargarnejad hospital, Kashan, IRAN
    Street address - Persian: کاشان- کیلومتر 5 بلوار قطب راوندی - بیمارستان کارگرنژاد
    City - English: Kashan
    City - Persian: كاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Kargarnejad Hospital
    Name of recruitment center - Persian: بیمارستان کارگرنژاد
    Full name of responsible person - English: Dr. Zahra Kashani-Poor
    Full name of responsible person - Persian: دکتر زهرا كاشاني پور
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: كاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 31 5546 3378
    Fax:
    Email: zkashani@kaums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Research Department of Kashan University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشي دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr. Gholam Ali Hamidi
    Full name of responsible person - Persian: دكتر غلامعلي حميدي
    Street address - English: 5th of Qotb –e Ravandi Blvd, Kashan
    Street address - Persian: کیلومتر 5 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: Research Department of Kashan University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشي دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr. Gholam Ali Hamidi
    Full name of responsible person - Persian: دكتر غلامعلي حميدي
    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: 8715988141
    Phone: +98 31 5546 3378
    Fax:
    Email: zkashani@kaums.ac.ir
    Web page address:
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    Public
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    Domestic
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    Academic
    #2
    contact.organization_id:
    Name of organization / entity - English: Research Department of Kashan University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشي دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr. Gholam Ali Hamidi
    Full name of responsible person - Persian: دكتر غلامعلي حميدي
    Street address - English: 5th of Qotb –e Ravandi Blvd, Kashan, IRAN
    Street address - Persian: کاشان- کیلومتر 5 بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
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    Yes
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    Research Department of Kashan University of Medical Sciences
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    معاونت پژوهشي دانشگاه علوم پزشکی کاشان
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  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Research Department of Kashan University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشي دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr. Gholam Ali Hamidi
    Full name of responsible person - Persian: دكتر غلامعلي حميدي
    Position - English: Ph.D. (Physiology)
    Position - Persian: دکتری تخصصی فیزیولوژی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 5th of Qotb –e Ravandi Blvd, Kashan
    Street address - Persian: کاشان- کیلومتر 5 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 5554 2999
    Mobile: +98 913 163 1685
    Fax: +98 55575057
    Email: hamiidi@yahoo.com
    Web page address: hamidi_gh_at_kaums.ac.ir
    contact.organization_id:
    Name of organization / entity - English: Research Department of Kashan University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشي دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr. Gholam Ali Hamidi
    Full name of responsible person - Persian: دكتر غلامعلي حميدي
    Position - English: Ph.D. (Physiology)
    Position - Persian: دکتری تخصصی فیزیولوژی
    Latest degree: phd
    Area of specialty/work: 69
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5554 2999
    Mobile: +98 913 163 1685
    Fax: +98 31 5557 5057
    Email: hamiidi@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: Dr. Zatollah Asemi
    Full name of responsible person - Persian: دکتر ذات اله عاصمی
    Position - English: PhD in Nutrition
    Position - Persian: دکترای تخصصی تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 5th of Qotb –e Ravandi Blvd, Kashan
    Street address - Persian: کاشان- کیلومتر 5 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_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: Dr. Zatollah Asemi
    Full name of responsible person - Persian: دکتر ذات اله عاصمی
    Position - English: PhD in Nutrition
    Position - Persian: دکترای تخصصی تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_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: Dr. Zahra Kashani-Poor
    Full name of responsible person - Persian: دکتر زهرا كاشاني پور
    Position - English: Resident in Psychiatry
    Position - Persian: دستیار روانپزشکي
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 5th of Qotb –e Ravandi Blvd, Kargarnejad hospital, Kashan, IRAN
    Street address - Persian: کاشان- کیلومتر 5 بلوار قطب راوندی - بیمارستان اعصاب و روان کارگرنژاد
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8715973446
    Phone: +31 55549111
    Mobile: +93 73616737
    Fax: +98 55540036
    Email: zkashani313@gmail.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: Dr. Zahra Kashani-Poor
    Full name of responsible person - Persian: دکتر زهرا كاشاني پور
    Position - English: Resident in Psychiatry
    Position - Persian: دستیار روانپزشکي
    Latest degree: specialist
    Area of specialty/work: 47
    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: 8715973446
    Phone: +31 55549111
    Mobile: 0093 73616737
    Fax:
    Email: zkashani313@gmail.com
    Web page address:

  • Sharing plan

    undecided
    undecided
    na
    undecided
    na
    na
    na
    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 effect of probiotic capsule supplementation on severity depression among patients with major depressive disorder under treatment with citalopram.
Design
Among patients with major depressive referred to the Kargarneghad Clinic affiliated to Kashan Medical Sciences University, Kashan, Iran, 40 patients will be selected. The study will be double blind in which participants and investigators/the assessors of the outcomes are unaware of the study groups and drug and placebo are similar. Fasting blood samples will be taken at baseline and end of the intervention. Intervention period: 8 weeks.
Settings and conduct
40 patients with major depressive disorder of eligible and referred to Karganejad hospital to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with major depressive, aged between 20 to 55 years. Exclusion criteria: Age <20 y or >55 y; a history of coronary infarction, angina pectoris, pregnancy or lactation, substance abuse; taking dietary supplements or probiotic supplements during the previous 2 months
Intervention groups
Patients will be assigned to receive either the probiotic capsule (intervention group: n=20) or placebo capsule (control group: n=20).
Main outcome variables
Beck Depression Inventory (primary outcome), and glycemic control, lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes)

General information

Reason for update
Due to an error, the request for an update in our website has 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: IRCT2014060717993N1
Registration date: 2014-11-04, 1393/08/13
Registration timing: retrospective

Last update: 2020-10-12, 1399/07/21
Update count: 1
Registration date
2014-11-04, 1393/08/13
Registrant information
Name
Zahra Kashanipoor
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 1112
Email address
zkashani@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
TAK GENE ZIST Co , Tehran , Iran. Kashan University of Medical Sciences.
Expected recruitment start date
2014-07-01, 1393/04/10
Expected recruitment end date
2014-07-15, 1393/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic capsule supplementation on severity depression among patients with major depressive disorder under treatment with citalopram
Public title
The effect of probiotic capsule supplementation on severity depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with major depressive Aged between 20 to 55 years
Exclusion criteria:
Age <20 y or >55 years A history of coronary infarction Angina pectoris Pregnancy or lactation Substance abuse Taking dietary supplements or probiotic supplements during the previous 2 months
Age
From 20 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 40 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic, who is not involved in the trial and not aware of random sequences, will assign the participants to the numbered bottles of drugs. Supplements and placebos are in the same packaging at the Tak Gen Zist pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of intervention. After analyzing the data, pocket codes will be decoded. Participants and investigators/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
Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2014-06-09, 1393/03/19
Ethics committee reference number
93044

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode

Primary outcomes

1

Description
Severity depression
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Questionnaire Beck

Secondary outcomes

1

Description
Insulin resistance
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Calculation using the Homeostasis Model Assessment (HOMA) formula

2

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

3

Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit

4

Description
Total cholesterol
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit

5

Description
Triglycerides
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit

6

Description
High-density lipoprotein (HDL)
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit

7

Description
Low-density lipoprotein (LDL)
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit

8

Description
High-sensitivity C-reactive Protein (hs-CRP)
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
ELISA kit

9

Description
Glutathione
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry

10

Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry

Intervention groups

1

Description
Multi species probiotic capsules containing Lactobacillus acidophilus 2× 109 CFU, Lactobacillus casei 2× 109 CFU, Bifidbacterium bifidum 2 × 109 CFU.
Category
Placebo

2

Description
Control group: Placebo capsule, daily, for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kargarnejad Hospital
Full name of responsible person
Dr. Zahra Kashani-Poor
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5546 3378
Email
zkashani@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Department of Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5546 3378
Email
zkashani@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department of 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
Research Department of Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Position
Ph.D. (Physiology)
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
hamiidi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zatollah Asemi
Position
PhD in Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_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
Dr. Zahra Kashani-Poor
Position
Resident in Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+31 55549111
Fax
Email
zkashani313@gmail.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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