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Protocol summary
Objective: The aim of this study is to determine the effects of synbiotic supplementation on metabolic profiles in patients with rheumatoid arthritis. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with rheumatoid arthritis and aged 25 to 75 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with rheumatoid arthritis of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either synbiotic (n=30) or placebo (n=30). Synbiotic and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and end of the intervention: 8 weeks. Outcomes: Inflammatory factors (primary outcomes), markers of insulin metabolism, lipid profiles and biomarkers of oxidative stress (secondry outcomes) 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 synbiotic supplementation on metabolic profiles in patients with rheumatoid arthritis. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with rheumatoid arthritis and aged 25 to 75 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with rheumatoid arthritis of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either synbiotic (n=30) or placebo (n=30). Synbiotic and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and end of the intervention: 8 weeks. Outcomes: Inflammatory factors (primary outcomes), markers of insulin metabolism, lipid profiles and biomarkers of oxidative stress (secondry outcomes) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری سین بیوتیک بر پروفایل های متابولیک در بیماران مبتلا به آرتریت روماتوئید است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به آرتریت روماتوئید در محدوده سنی 25 تا 75 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به آرتریت روماتوئید واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا مکمل سین بیوتیک (30=n) یا پلاسبو (30=n) تقسیم خواهند شد. کپسول های مکمل سین بیوتیک و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته. پيامدها: فاکتورهای التهابی (پیامدهای اولیه)، مارکرهای متابولیسم انسولین، پروفایل های لیپیدی و بیومارکرهای استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری سین بیوتیک بر پروفایل های متابولیک در بیماران مبتلا به آرتریت روماتوئید است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به آرتریت روماتوئید در محدوده سنی 25 تا 75 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به آرتریت روماتوئید واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا مکمل سین بیوتیک (30=n) یا پلاسبو (30=n) تقسیم خواهند شد. کپسول های مکمل سین بیوتیک و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته. پيامدها: فاکتورهای التهابی (پیامدهای اولیه)، مارکرهای متابولیسم انسولین، پروفایل های لیپیدی و بیومارکرهای استرس اکسیداتیو (پیامدهای 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 synbiotic supplementation on metabolic profiles in patients with rheumatoid arthritis.
The aim of this study is to determine the effects of synbiotic supplementation on metabolic profiles in patients with rheumatoid arthritis.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری سین بیوتیک بر پروفایل های متابولیک در بیماران مبتلا به آرتریت روماتوئید است.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری سین بیوتیک بر پروفایل های متابولیک در بیماران مبتلا به آرتریت روماتوئید است.
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Study design: randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive synbiotic supplement (n=27) or placebo (n=27).
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 synbiotic supplement (n=27) or placebo (n=27).
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طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل سین بیوتیک (27=n) یا پلاسبو (27=n) اختصاص داده خواهند شد.
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل سین بیوتیک (27=n) یا پلاسبو (27=n) اختصاص داده خواهند شد.
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Among with rheumatoid arthritis patients referred to Shahid Beheshti Clinic, 54 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and the end of the intervention: 8 weeks.
Among with rheumatoid arthritis patients referred to Shahid Beheshti Clinic, 54 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and the end of the intervention: 8 weeks.
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از بین بیماران مبتلا به آرتریت روماتوئید ارجاع شده به کلینیک شهید بهشتی، 54 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته.
از بین بیماران مبتلا به آرتریت روماتوئید ارجاع شده به کلینیک شهید بهشتی، 54 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته.
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Inclusion criteria: Patients with rheumatoid arthritis and aged 25 to 70 years.
Exclusion criteria: Patients who have chronic renal failure, pregnant or lactating women, symptoms or personal history of cardiovascular disease, diabetes mellitus, the consumption of antihyperglycemic agents, patients unlikely to come for follow-up in the following 3 months and patients who are unable to read numbers and/or unable to mark the pain scale, taking probiotics, synbiotics, antioxidant and/or anti-inflammatory supplements, taking antibiotics.
Inclusion criteria: Patients with rheumatoid arthritis and aged 25 to 70 years. Exclusion criteria: Patients who have chronic renal failure, pregnant or lactating women, symptoms or personal history of cardiovascular disease, diabetes mellitus, the consumption of antihyperglycemic agents, patients unlikely to come for follow-up in the following 3 months and patients who are unable to read numbers and/or unable to mark the pain scale, taking probiotics, synbiotics, antioxidant and/or anti-inflammatory supplements, taking antibiotics.
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معیار ورود به مطالعه: بیماران مبتلا به آرتریت روماتوئید، در محدوده سنی 25 تا 70 سال.
معیار خروج از مطالعه: بیمارانی که اختلال کلیوی مزمن داشتند، زنان باردار، زنان شیرده، علائم یا سابقه خانوادگی بیماری قلبی عروقی، دیابت ملیتوس، مصرف داروهای کاهنده قند خون، بیمارانی که قادر نیستند برای مداخله 3 ماهه مراجعه نمایند، بیمارانی که قادر نیستند اعداد را بخوانند و/یا امتیاز درد را علامت بزنند، گرفتن مکمل های پروبیوتیک ها، سین بیوتیک ها، آنتی اکسیدانت و/یا ضد التهابی، گرفتن آنتی بیوتیک ها.
معیار ورود به مطالعه: بیماران مبتلا به آرتریت روماتوئید، در محدوده سنی 25 تا 70 سال. معیار خروج از مطالعه: بیمارانی که اختلال کلیوی مزمن داشتند، زنان باردار، زنان شیرده، علائم یا سابقه خانوادگی بیماری قلبی عروقی، دیابت ملیتوس، مصرف داروهای کاهنده قند خون، بیمارانی که قادر نیستند برای مداخله 3 ماهه مراجعه نمایند، بیمارانی که قادر نیستند اعداد را بخوانند و/یا امتیاز درد را علامت بزنند، گرفتن مکمل های پروبیوتیک ها، سین بیوتیک ها، آنتی اکسیدانت و/یا ضد التهابی، گرفتن آنتی بیوتیک ها.
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Intervention group: Synbiotic supplements (Tak Gen Zist Pharmaceutical Company, Tehran, Iran), one capsule for 8 weeks orally. Control group: placebo (Tak Gen Zist Pharmaceutical Company, Tehran, Iran), one capsule for 8 weeks orally.
Intervention group: Synbiotic supplements (Tak Gen Zist Pharmaceutical Company, Tehran, Iran), one capsule for 8 weeks orally. Control group: placebo (Tak Gen Zist Pharmaceutical Company, Tehran, Iran), one capsule for 8 weeks orally.
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گروه مداخله: مکمل سین بیوتیک (تک ژن زیست، تهران، ایران)، یک کپسول برای 8 هفته به صورت خوراکی. گروه کنترل: کپسول پلاسبو (تک ژن زیست، تهران، ایران)، یک کپسول برای 8 هفته به صورت خوراکی.
گروه مداخله: مکمل سین بیوتیک (تک ژن زیست، تهران، ایران)، یک کپسول برای 8 هفته به صورت خوراکی. گروه کنترل: کپسول پلاسبو (تک ژن زیست، تهران، ایران)، یک کپسول برای 8 هفته به صورت خوراکی.
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Outcomes: Inflammatory factors and DAS-28 (primary outcomes), markers of insulin metabolism, lipid profiles and biomarkers of oxidative stress (secondry outcomes) will be quantified at study baseline and end-of-trial.
Outcomes: Inflammatory factors and DAS-28 (primary outcomes), markers of insulin metabolism, lipid profiles and biomarkers of oxidative stress (secondry outcomes) will be quantified at study baseline and end-of-trial.
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يامدها: فاکتورهای التهابی و DAS-28 (پیامدهای اولیه)، مارکرهای متابولیسم انسولین، پروفایل های لیپیدی و بیومارکرهای استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
يامدها: فاکتورهای التهابی و DAS-28 (پیامدهای اولیه)، مارکرهای متابولیسم انسولین، پروفایل های لیپیدی و بیومارکرهای استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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Patients with rheumatoid arthritis
Aged 25 to 70 years
Patients with rheumatoid arthritis Aged 25 to 70 years
بیماران مبتلا به آرتریت روماتوئید
در محدوده سنی 25 تا 70 سال
بیماران مبتلا به آرتریت روماتوئید در محدوده سنی 25 تا 70 سال
Patients who had chronic renal failure
Pregnant
Lactating women
Symptoms or personal history of cardiovascular disease, diabetes mellitus
The consumption of antihyperglycemic agents
Patients unlikely to come for follow-up in the following 3 months
Patients who are unable to read numbers and/or unable to mark the pain scale
Taking probiotics, synbiotics, antioxidant and/or anti-inflammatory supplements
Taking antibiotics
Patients who had chronic renal failure Pregnant Lactating women Symptoms or personal history of cardiovascular disease, diabetes mellitus The consumption of antihyperglycemic agents Patients unlikely to come for follow-up in the following 3 months Patients who are unable to read numbers and/or unable to mark the pain scale Taking probiotics, synbiotics, antioxidant and/or anti-inflammatory supplements Taking antibiotics
بیمارانی که اختلال کلیوی مزمن داشتند
زنان باردار
زنان شیرده
علائم یا سابقه خانوادگی بیماری قلبی عروقی، دیابت ملیتوس
مصرف داروهای کاهنده قند خون
بیمارانی که قادر نیستند برای مداخله 3 ماهه مراجعه نمایند
بیمارانی که قادر نیستند اعداد را بخوانند و/یا امتیاز درد را علامت بزنند
گرفتن مکمل های پروبیوتیک ها، سین بیوتیک ها، آنتی اکسیدانت و/یا ضد التهابی
گرفتن آنتی بیوتیک ها
بیمارانی که اختلال کلیوی مزمن داشتند زنان باردار زنان شیرده علائم یا سابقه خانوادگی بیماری قلبی عروقی، دیابت ملیتوس مصرف داروهای کاهنده قند خون بیمارانی که قادر نیستند برای مداخله 3 ماهه مراجعه نمایند بیمارانی که قادر نیستند اعداد را بخوانند و/یا امتیاز درد را علامت بزنند گرفتن مکمل های پروبیوتیک ها، سین بیوتیک ها، آنتی اکسیدانت و/یا ضد التهابی گرفتن آنتی بیوتیک ها
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At study baseline and after balanced 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 balanced 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.
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در ابتدای مطالعه و بعد از تصادفی سازی 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 تصادفی سازی 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.
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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
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DAS-28
DAS-28
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DAS-28
DAS-28
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At the beginning of the study and after 8 weeks of intervention
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
در ابتدای مطالعه و 8 هفته بعد از مداخله
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Sum scores
Sum scores
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مجموع امتیازها
مجموع امتیازها
Secondary outcomes
#1
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Fasting plasma glucose
Fasting plasma glucose
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قند خون ناشتا
قند خون ناشتا
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At the beginning of the study and after 8 weeks of intervention
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
در ابتدای مطالعه و 8 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#2
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Insulin resistance
Insulin resistance
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مقاومت به انسولین
مقاومت به انسولین
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At the beginning of the study and after 8 weeks of intervention
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
در ابتدای مطالعه و 8 هفته بعد از مداخله
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Calculation using HOMA formula
Calculation using HOMA formula
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محاسبه با استفاده از فرمول HOMA
محاسبه با استفاده از فرمول HOMA
Intervention groups
#1
Intervention group: Synbiotic capsule containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), and 0.8 g inulin (Takgene Zist, Tehran, Iran), once a day, for 8 weeks orally.
Intervention group: Synbiotic capsule containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), and 0.8 g inulin (Tak Gen Zist, Tehran, Iran), once a day, for 8 weeks orally.
Intervention group: Synbiotic capsule containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), and 0.8 g inulin (TakgeneTak Gen Zist, Tehran, Iran), once a day, for 8 weeks orally.
#2
Inclusion criteria: Patients with rheumatoid arthritis; aged 25 to 75 years. Exclusion criteria: Unwillingness to cooperate.
Conrol group: Placebo (Tak Gen Zist, Tehran, Iran), once a day, for 8 weeks orally.
Inclusion criteriaConrol group: Patients with rheumatoid arthritis; aged 25 to 75 yearsPlacebo (Tak Gen Zist, Tehran, Iran), once a day, for 8 weeks orally. Exclusion criteria: Unwillingness to cooperate.
گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران)، یک بار در روز، به صورت خوراکی برای 8 هفته.
گروه کنترل: پلاسبو (تک ژن زیست، تهران، ایران)، یک بار در روز، به صورت خوراکی برای 8 هفته.
گروه کنترل: پلاسبو (باریج اسانستک ژن زیست، کاشانتهران، ایران)، یک بار در روز، به صورت خوراکی برای 8 هفته.
Recruitment centers
#1
Name of recruitment center - English: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Shahid Beheshti Clinic
Name of recruitment center - Persian: کلینیک شهید بهشتی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5554 0026
Fax:
Email: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: NaghaviShahid Beheshti Clinic Name of recruitment center - Persian: کلینیک نقویشهید بهشتی Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Street address - English: Shahid Rajaee AvenueGhotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، خیابان شهید رجاییبلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5554 0026 Fax: Email: asemi_r@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5554 2999
Fax:
Email: hamidi-gh@kaumas.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Gholamali Hamidi Full name of responsible person - Persian: غلامعلی حمیدی Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5554 2999 Fax: Email: hamidi-gh@kaumas.ac.ir 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:
Name of organization / entity - Persian:
Full name of responsible person - English:
Full name of responsible person - Persian:
Position - English:
Position - Persian:
Latest degree:
Area of specialty/work:
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English:
Street address - Persian:
City - English:
City - Persian:
Province:
Province - English:
Province - Persian:
contact.provinces_available:
Country:
Postal code:
Phone:
Mobile:
Fax:
Email:
Web page address:
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: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_r@yahoo.com
Web page address:
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: Associate professor Position - Persian: دانشیار Latest degree: phd Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_r@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
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_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: 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: +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: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_r@yahoo.com
Web page address:
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: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
na
na
undecided
undecided
na
na
na
na
na
na
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 synbiotic supplementation on metabolic profiles in patients with rheumatoid arthritis.
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 synbiotic supplement (n=27) or placebo (n=27).
Settings and conduct
Among with rheumatoid arthritis patients referred to Shahid Beheshti Clinic, 54 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and the end of the intervention: 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with rheumatoid arthritis and aged 25 to 70 years.
Exclusion criteria: Patients who have chronic renal failure, pregnant or lactating women, symptoms or personal history of cardiovascular disease, diabetes mellitus, the consumption of antihyperglycemic agents, patients unlikely to come for follow-up in the following 3 months and patients who are unable to read numbers and/or unable to mark the pain scale, taking probiotics, synbiotics, antioxidant and/or anti-inflammatory supplements, taking antibiotics.
Intervention groups
Intervention group: Synbiotic supplements (Tak Gen Zist Pharmaceutical Company, Tehran, Iran), one capsule for 8 weeks orally. Control group: placebo (Tak Gen Zist Pharmaceutical Company, Tehran, Iran), one capsule for 8 weeks orally.
Main outcome variables
Outcomes: Inflammatory factors and DAS-28 (primary outcomes), markers of insulin metabolism, lipid profiles and biomarkers of oxidative stress (secondry outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201611165623N94
Registration date:2016-11-18, 1395/08/28
Registration timing:retrospective
Last update:2019-09-14, 1398/06/23
Update count:1
Registration date
2016-11-18, 1395/08/28
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2016-08-08, 1395/05/18
Expected recruitment end date
2016-09-08, 1395/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of synbiotic supplementation compared with the placebo on metabolic profiles in patients with rheumatoid arthritis
Public title
Effect of supplementation in treatment of patients with rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with rheumatoid arthritis
Aged 25 to 70 years
Exclusion criteria:
Patients who had chronic renal failure
Pregnant
Lactating women
Symptoms or personal history of cardiovascular disease, diabetes mellitus
The consumption of antihyperglycemic agents
Patients unlikely to come for follow-up in the following 3 months
Patients who are unable to read numbers and/or unable to mark the pain scale
Taking probiotics, synbiotics, antioxidant and/or anti-inflammatory supplements
Taking antibiotics
Age
From 25 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after balanced 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
Random assignment will be done by the use of computer-generated random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2016-08-07, 1395/05/17
Ethics committee reference number
IR.Kaums.REC.1395.46
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M00.2
ICD-10 code description
Other streptococcal arthritis and polyarthritis
Primary outcomes
1
Description
Hs-CRP
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Elisa kit
2
Description
Nitric oxide
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
DAS-28
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Sum scores
Secondary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Elisa kit
2
Description
Total antioxidant
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Glutathione
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Triglycerides
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
Total cholesterol
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
7
Description
HDL
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
8
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
9
Description
Insulin resistance
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Calculation using HOMA formula
Intervention groups
1
Description
Intervention group: Synbiotic capsule containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), and 0.8 g inulin (Tak Gen Zist, Tehran, Iran), once a day, for 8 weeks orally.
Category
Treatment - Drugs
2
Description
Conrol group: Placebo (Tak Gen Zist, Tehran, Iran), once a day, for 8 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Clinic
Full name of responsible person
Zatollah Asemi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Email
asemi_r@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 2999
Email
hamidi-gh@kaumas.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available