Assessing the effect of Adjunctive probiotics therapy for the treatment of primary hypertension in children and adolescents: A randomized, double- blind, placebo- controlled trial
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Protocol summary
This is a controlled double-blind clinical trial with a parallel group, which will be conducted on 56 patients. Patients were randomly assigned to groups using randomizer computer software with 4 and 6 block sizes and 1:1 allocation.
This is a phase 3 randomized controlled double-blind clinical trial with parallel-group which will be conducted on 66 patients. patients were randomly assigned to groups using randomizer computer software with 4 and 6 block sizes and1: 1 allocation.
This is a phase 3 randomized controlled double-blind clinical trial with a parallel-group, which will be conducted on 5666 patients. Patientspatients were randomly assigned to groups using randomizer computer software with 4 and 6 block sizes and 1and1:1 allocation.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، فاز 3 بر روی 56 بیمار. تصادفی سازی با استفاده از نرم افزار کامپیوتری Randomizer و به روش بلوک بندی تصادفی با سایز بلوک های 4 و 6 تایی با تخصیص 1:1 انجام شد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، دو سویه کور ، تصادفی شده، فاز 3 بر روی 66 بیمار. تصادفی سازی با استفاده از نرم افزار کامپیوتری Randomizer و به روش بلوک بندی تصادفی با سایز بلوک های 4 و 6 تایی با تخصیص 1:1 انجام شد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، فاز 3 بر روی 5666 بیمار. تصادفی سازی با استفاده از نرم افزار کامپیوتری Randomizer و به روش بلوک بندی تصادفی با سایز بلوک های 4 و 6 تایی با تخصیص 1:1 انجام شد.
Children between 10 and 18 years of age with elevated blood pressure and stage I and II HTN who are referred to the Nephrology Clinic of 17 Shahrivar Children's Center of Rasht, Children's Medical Center of Tehran University, Semnan Hospital, Zahedan Children's Hospital, and Mashhad Children's Hospital will be investigated. In the intervention group, patients received probiotic capsules 2 times a day. Participants in the control group received placebos. Double blinding is done for the participants and the investigator.
Children between 7 and 18 years of age with high blood pressure or grade I and II basic HTN referred to the Nephrology Clinic of 17 Shahrivar Children's Center of Rasht, Children's Medical Center of Tehran University, Ali Asghar Children's Center , Mofid Children's Center of Shahid Beheshti University, Namazi Hospital, Semnan Hospital, Zahedan Children's Hospital, Mashhad Children's Hospital will be investigated. In the intervention group, patients received probiotic capsule 2 times a day.Participants in the control group received placebo. Double blinding is done for the participants and the investigator.
Children between 107 and 18 years of age with elevatedhigh blood pressure and stageor grade I and II basic HTN who are referred to the Nephrology Clinic of 17 Shahrivar Children's Center of Rasht, Children's Medical Center of Tehran University, Ali Asghar Children's Center , Mofid Children's Center of Shahid Beheshti University, Namazi Hospital, Semnan Hospital, Zahedan Children's Hospital, and Mashhad Children's Hospital will be investigated. In the intervention group, patients received probiotic capsulescapsule 2 times a day. Participantsday.Participants in the control group received placebosplacebo. Double blinding is done for the participants and the investigator.
کودکان بین 10 تا 18 سال با فشار خون بالا یا درجه I و II HTN اساسی مراجعه کننده به کلینیک نفرولوژی مراکز کودکان 17شهریور رشت، مرکز طبی کودکان دانشگاه تهران، بیمارستان سمنان، بیمارستان کودکان زاهدان، بیمارستان کودکان مشهد مورد بررسی قرار خواهند گرفت. در گروه مداخله، محتویات کپسول پروبیوتیک 2 بار در روز تجویز می شود.
شرکت‌کنندگان در گروه کنترل، دارونما دریافت خواهند کرد. دوسو کورسازی برای شرکت کنندگان و محقق انجام می شود.
کودکان بین 7 تا 18 سال با فشار خون بالا یا درجه I و II HTN اساسی مراجعه کننده به کلینیک نفرولوژی مراکز کودکان 17شهریور رشت، مرکز طبی کودکان دانشگاه تهران، مرکز کودکان علی اصغر ، مرکز کودکان مفید دانشگاه شهید بهشتی ، بیمارستان نمازی شیراز، بیمارستان سمنان، بیمارستان کودکان زاهدان، بیمارستان کودکان مشهد مورد بررسی قرار خواهند گرفت. در گروه مداخله، محتویات کپسول پروبیوتیک 2 بار در روز تجویز می شود.
شرکت‌کنندگان در گروه کنترل، دارونما دریافت خواهند کرد. دوسو کورسازی برای شرکت کنندگان و محقق انجام می شود.
کودکان بین 107 تا 18 سال با فشار خون بالا یا درجه I و II HTN اساسی مراجعه کننده به کلینیک نفرولوژی مراکز کودکان 17شهریور رشت، مرکز طبی کودکان دانشگاه تهران، مرکز کودکان علی اصغر ، مرکز کودکان مفید دانشگاه شهید بهشتی ، بیمارستان نمازی شیراز، بیمارستان سمنان، بیمارستان کودکان زاهدان، بیمارستان کودکان مشهد مورد بررسی قرار خواهند گرفت. در گروه مداخله، محتویات کپسول پروبیوتیک 2 بار در روز تجویز می شود. شرکت‌کنندگان در گروه کنترل، دارونما دریافت خواهند کرد. دوسو کورسازی برای شرکت کنندگان و محقق انجام می شود.
Patients with elevated blood pressure and 1st and 2nd stages of hypertension in the age range of 10 to 18 years will be included in the study. Exclusion criteria were known organ damage, active infection, use of probiotics in the 3 months before the study, and previous history of sensitivity to probiotics.
Patients with high blood pressure of the 1st and 2nd degree in the age range of 7 to 18 years will be included in the study. Exclusion criteria were known organ damage, active infection, use of probiotics in the 4 months before the study, and previous history of sensitivity to probiotics.
Patients with elevatedhigh blood pressure andof the 1st and 2nd stages of hypertensiondegree in the age range of 107 to 18 years will be included in the study. Exclusion criteria were known organ damage, active infection, use of probiotics in the 34 months before the study, and previous history of sensitivity to probiotics.
بیماران با فشار خون بالای درجه 1 و 2 اساسی در محدوده سنی 10 تا 18 سال وارد مطالعه خواهند شد. معیار خروج آسیب شناخته شده اندام، عفونت فعال، استفاده از پروبیوتیک ها در 3 ماه قبل از مطالعه، و سابقه قبلی حساسیت به پروبیوتیک ها می باشد.
بیماران با فشار خون بالای درجه 1 و 2 اساسی در محدوده سنی 7 تا 18 سال وارد مطالعه خواهند شد. معیار خروج آسیب شناخته شده اندام، عفونت فعال، استفاده از پروبیوتیک ها در 4 ماه قبل از مطالعه، و سابقه قبلی حساسیت به پروبیوتیک ها می باشد.
بیماران با فشار خون بالای درجه 1 و 2 اساسی در محدوده سنی 107 تا 18 سال وارد مطالعه خواهند شد. معیار خروج آسیب شناخته شده اندام، عفونت فعال، استفاده از پروبیوتیک ها در 34 ماه قبل از مطالعه، و سابقه قبلی حساسیت به پروبیوتیک ها می باشد.
Intervention group: In children under 40 kg body weight, the contents of a 500 mg probiotic capsule (Milad Pharmed Gostar company under the brand name Prokid) containing 11 strains are dissolved in 10 ml of 5% dextrose water and administered as 0.5 ml/kg twice a day. Its amount will be 20 ml with or without food for 12 weeks.
Control group: Patients in the placebo group will receive the bacteria-free capsules filled with maltodextrin daily for 3 months.
Intervention group: The contents of a 500 mg probiotic capsule (Milad Pharmed Gostar company under the brand name Prokid) containing 11 strains are dissolved in 10 ml of 5% dextrose water and administered as 0.5 ml/kg twice a day. Its amount will be 20 ml with or without food for 16 weeks.
Control group: Patients in the placebo group will receive 2 bacteria-free capsules filled with maltodextrin daily for four months.
Intervention group: In children under 40 kg body weight, theThe contents of a 500 mg probiotic capsule (Milad Pharmed Gostar company under the brand name Prokid) containing 11 strains are dissolved in 10 ml of 5% dextrose water and administered as 0.5 ml/kg twice a day. Its amount will be 20 ml with or without food for 1216 weeks. Control group: Patients in the placebo group will receive the2 bacteria-free capsules filled with maltodextrin daily for 3four months.
گروه مداخله: محتویات یک کپسول پروبیوتیک 500 میلی گرمی (شرکت گسترش میلاد فارمد به نام تجاری پروکید ) حاوی 11 سویه در 10 میلی لیتر آب دکستروز 5 درصد حل می شود و به صورت 0.5 میلی لیتر / کیلوگرم 2 بار در روز تجویز می شود. میزان ان 20 میلی لیتر با یا بدون غذا به مدت 12هفته خواهد بود.
گروه کنترل: بیماران گروه دارونما به مدت سه ماه روزانه 2 کپسول بدون باکتری که با مالتودکسترین پرشده است دریافت خواهند کرد.
گروه مداخله: محتویات یک کپسول پروبیوتیک 500 میلی گرمی (شرکت گسترش میلاد فارمد به نام تجاری پروکید ) حاوی 11 سویه در 10 میلی لیتر آب دکستروز 5 درصد حل می شود و به صورت 0.5 میلی لیتر / کیلوگرم 2 بار در روز تجویز می شود. میزان ان 20 میلی لیتر با یا بدون غذا به مدت 16 هفته خواهد بود.
گروه کنترل: بیماران گروه دارونما به مدت چهار ماه روزانه 2 کپسول بدون باکتری که با مالتودکسترین پرشده است دریافت خواهند کرد.
گروه مداخله: محتویات یک کپسول پروبیوتیک 500 میلی گرمی (شرکت گسترش میلاد فارمد به نام تجاری پروکید ) حاوی 11 سویه در 10 میلی لیتر آب دکستروز 5 درصد حل می شود و به صورت 0.5 میلی لیتر / کیلوگرم 2 بار در روز تجویز می شود. میزان ان 20 میلی لیتر با یا بدون غذا به مدت 12هفته16 هفته خواهد بود. گروه کنترل: بیماران گروه دارونما به مدت سهچهار ماه روزانه 2 کپسول بدون باکتری که با مالتودکسترین پرشده است دریافت خواهند کرد.
The primary outcome is a reduction in systolic blood pressure from baseline to 3 mmHg after 12 weeks of treatment
The primary outcome is a reduction in systolic blood pressure from baseline to 3 mmHg after 16 weeks of treatment
The primary outcome is a reduction in systolic blood pressure from baseline to 3 mmHg after 1216 weeks of treatment
پیامد اولیه کاهش فشار خون سیستولیک از مقدار پایه به میزان ۳ میلی متر جیوه پس از 12هفته درمان است
پیامد اولیه کاهش فشار خون سیستولیک از مقدار پایه به میزان ۳ میلی متر جیوه پس از ۱۶ هفته درمان است
پیامد اولیه کاهش فشار خون سیستولیک از مقدار پایه به میزان ۳ میلی متر جیوه پس از 12هفته۱۶ هفته درمان است
General information
10
7
107
1
1
1
1
1
1
1
1
empty
3
03
56
66
5666
Yes
No
1
28
empty
28
2025-03-30, 1404/01/10
2025-07-16, 1404/04/25
2025-0307-3016 00:00:00
Inadequate participants enrollement
Due to the request from The Vice-Chancellor of Research
Inadequate participants enrollementDue to the request from The Vice-Chancellor of Research
ناکافی بودن تعداد شرکت کنندگان
به دلیل درخواست از شورای پژوهش دانشگاه
ناکافی بودن تعداد شرکت کنندگانبه دلیل درخواست از شورای پژوهش دانشگاه
Elevated blood pressure and essential high blood pressure I and II
Age range between 10-18 years
Essential high blood pressure I and II
Age range between 7-18 years
Elevated blood pressure and essentialEssential high blood pressure I and II Age range between 107-18 years
فشار خون بالای درجه I و II اساسی
محدوده سنی10 تا 18سال
فشار خون بالای درجه I و II اساسی
محدوده سنی 7تا 18سال
فشار خون بالای درجه I و II اساسی محدوده سنی10 تاسنی 7تا 18سال
Conventional antihypertensive medication with or without probiotics
empty
Conventional antihypertensive medication with or without probiotics
درمان ضد فشار خون متعارف با و بدون پروبیوتیک
empty
درمان ضد فشار خون متعارف با و بدون پروبیوتیک
Primary outcomes
#1
After 12 weeks of treatment
After 16 weeks of treatment
After 1216 weeks of treatment
پس از 12هفته درمان
پس از ۱۶ هفته درمان
پس از 12هفته۱۶ هفته درمان
Intervention groups
#1
Intervention group: In children under 40 kg, a 500 mg probiotic capsule (Milad Pharmed Gostar company under the brand name Prokid) containing 11 strains is dissolved in 10 ml of 5% dextrose water and administered as 0.5 ml/kg twice a day. Its amount will be 20 ml with or without food for 12 weeks.
Intervention group: The contents of a 500 mg probiotic capsule (Milad Pharmed Gostar company under the brand name Prokid) containing 11 strains are dissolved in 10 ml of 5% dextrose water and administered as 0.5 ml/kg twice a day. Its amount will be 20 ml with or without food for 16 weeks.
Intervention group: In children under 40 kg,The contents of a 500 mg probiotic capsule (Milad Pharmed Gostar company under the brand name Prokid) containing 11 strains isare dissolved in 10 ml of 5% dextrose water and administered as 0.5 ml/kg twice a day. Its amount will be 20 ml with or without food for 1216 weeks.
گروه مداخله: محتویات یک کپسول پروبیوتیک 500 میلی گرمی (شرکت گسترش میلاد فارمد به نام تجاری پروکید ) حاوی 11 سویه در 10 میلی لیتر آب دکستروز 5 درصد حل می شود و به صورت 0.5 میلی لیتر / کیلوگرم 2 بار در روز تجویز می شود. میزان ان 20 میلی لیتر با یا بدون غذا به مدت 12هفته خواهد بود.
گروه مداخله: محتویات یک کپسول پروبیوتیک 500 میلی گرمی (شرکت گسترش میلاد فارمد به نام تجاری پروکید ) حاوی 11 سویه در 10 میلی لیتر آب دکستروز 5 درصد حل می شود و به صورت 0.5 میلی لیتر / کیلوگرم 2 بار در روز تجویز می شود. میزان ان 20 میلی لیتر با یا بدون غذا به مدت 16 هفته خواهد بود.
گروه مداخله: محتویات یک کپسول پروبیوتیک 500 میلی گرمی (شرکت گسترش میلاد فارمد به نام تجاری پروکید ) حاوی 11 سویه در 10 میلی لیتر آب دکستروز 5 درصد حل می شود و به صورت 0.5 میلی لیتر / کیلوگرم 2 بار در روز تجویز می شود. میزان ان 20 میلی لیتر با یا بدون غذا به مدت 12هفته16 هفته خواهد بود.
#2
Control group: Patients in the placebo group will receive 2 bacteria-free capsules filled with maltodextrin daily for three months.
Control group: Patients in the placebo group will receive 2 bacteria-free capsules filled with maltodextrin daily for four months.
Control group: Patients in the placebo group will receive 2 bacteria-free capsules filled with maltodextrin daily for threefour months.
گروه کنترل: بیماران گروه دارونما به مدت سه ماه روزانه 2 کپسول بدون باکتری که با مالتودکسترین پرشده است دریافت خواهند کرد.
گروه کنترل: بیماران گروه دارونما به مدت چهار ماه روزانه 2 کپسول بدون باکتری که با مالتودکسترین پرشده است دریافت خواهند کرد.
گروه کنترل: بیماران گروه دارونما به مدت سهچهار ماه روزانه 2 کپسول بدون باکتری که با مالتودکسترین پرشده است دریافت خواهند کرد.
Sponsors / Funding sources
#1
4240-5925
empty
4240-5925
Guilan University of Medical Sciences
empty
Guilan University of Medical Sciences
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elham Bidabadi
Full name of responsible person - Persian: الهام بیدآبادی
Position - English: Professor
Position - Persian: استاد
Latest degree: sub_specialist
Area of specialty/work: 86
Area of specialty/work title - English: Pediatric Neurology
Area of specialty/work title - Persian: نورولوژی کودکان
Street address - English: No. 15, 135 ave., Golsar
Street address - Persian: گلسار، خیابان 135، پلاک 15
City - English: Rasht
City - Persian: رشت
Province: Guilan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4144444444
Phone: +98 13 3372 9104
Mobile: +98 911 331 0136
Fax:
Email: bidabadi@mail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elham Bidabadi
Full name of responsible person - Persian: الهام بیدآبادی
Position - English: Professor
Position - Persian: استاد
Latest degree: sub_specialist
Area of specialty/work: 86
Area of specialty/work title - English: Pediatric Neurology
Area of specialty/work title - Persian: نورولوژی کودکان
Street address - English: No. 15- 135 ave.- Golsar
Street address - Persian: گلسار- خیابان 135- پلاک 15
City - English: Rasht
City - Persian: رشت
Province: Guilan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4144444444
Phone: +98 13 3372 9104
Mobile: +98 911 331 0136
Fax:
Email: bidabadi@mail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Elham Bidabadi Full name of responsible person - Persian: الهام بیدآبادی Position - English: Professor Position - Persian: استاد Latest degree: sub_specialist Area of specialty/work: 86 Area of specialty/work title - English: Pediatric Neurology Area of specialty/work title - Persian: نورولوژی کودکان Street address - English: No. 15,- 135 ave.,- Golsar Street address - Persian: گلسار،- خیابان 135،- پلاک 15 City - English: Rasht City - Persian: رشت Province: Guilan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 4144444444 Phone: +98 13 3372 9104 Mobile: +98 911 331 0136 Fax: Email: bidabadi@mail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elham Bidabadi
Full name of responsible person - Persian: الهام بیدآبادی
Position - English: Professor
Position - Persian: استاد
Latest degree: sub_specialist
Area of specialty/work: 86
Area of specialty/work title - English: Pediatric Neurology
Area of specialty/work title - Persian: نورولوژی کودکان
Street address - English: No. 15, 135 ave., Golsar
Street address - Persian: گلسار، خیابان 135، پلاک 15
City - English: Rasht
City - Persian: رشت
Province: Guilan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4144444444
Phone: +98 13 3372 9104
Mobile: +98 911 331 0136
Fax:
Email: bidabadi@mail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elham Bidabadi
Full name of responsible person - Persian: الهام بیدآبادی
Position - English: Professor
Position - Persian: استاد
Latest degree: sub_specialist
Area of specialty/work: 86
Area of specialty/work title - English: Pediatric Neurology
Area of specialty/work title - Persian: نورولوژی کودکان
Street address - English: No. 15- 135 ave.- Golsar
Street address - Persian: گلسار- خیابان 135- پلاک 15
City - English: Rasht
City - Persian: رشت
Province: Guilan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4144444444
Phone: +98 13 3372 9104
Mobile: +98 911 331 0136
Fax:
Email: bidabadi@mail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Elham Bidabadi Full name of responsible person - Persian: الهام بیدآبادی Position - English: Professor Position - Persian: استاد Latest degree: sub_specialist Area of specialty/work: 86 Area of specialty/work title - English: Pediatric Neurology Area of specialty/work title - Persian: نورولوژی کودکان Street address - English: No. 15,- 135 ave.,- Golsar Street address - Persian: گلسار،- خیابان 135،- پلاک 15 City - English: Rasht City - Persian: رشت Province: Guilan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 4144444444 Phone: +98 13 3372 9104 Mobile: +98 911 331 0136 Fax: Email: bidabadi@mail.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elham Bidabadi
Full name of responsible person - Persian: الهام بیدآبادی
Position - English: Professor
Position - Persian: استاد
Latest degree: sub_specialist
Area of specialty/work: 86
Area of specialty/work title - English: Pediatric Neurology
Area of specialty/work title - Persian: نورولوژی کودکان
Street address - English: No. 15, 135 ave., Golsar
Street address - Persian: گلسار، خیابان 135، پلاک 15
City - English: Rasht
City - Persian: رشت
Province: Guilan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4144444444
Phone: +98 13 3372 9104
Mobile: +98 911 331 0136
Fax:
Email: bidabadi@mail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elham Bidabadi
Full name of responsible person - Persian: الهام بیدآبادی
Position - English: Professor
Position - Persian: استاد
Latest degree: sub_specialist
Area of specialty/work: 86
Area of specialty/work title - English: Pediatric Neurology
Area of specialty/work title - Persian: نورولوژی کودکان
Street address - English: No. 15- 135 ave.- Golsar
Street address - Persian: گلسار- خیابان 135- پلاک 15
City - English: Rasht
City - Persian: رشت
Province: Guilan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4144444444
Phone: +98 13 3372 9104
Mobile: +98 911 331 0136
Fax:
Email: bidabadi@mail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Elham Bidabadi Full name of responsible person - Persian: الهام بیدآبادی Position - English: Professor Position - Persian: استاد Latest degree: sub_specialist Area of specialty/work: 86 Area of specialty/work title - English: Pediatric Neurology Area of specialty/work title - Persian: نورولوژی کودکان Street address - English: No. 15,- 135 ave.,- Golsar Street address - Persian: گلسار،- خیابان 135،- پلاک 15 City - English: Rasht City - Persian: رشت Province: Guilan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 4144444444 Phone: +98 13 3372 9104 Mobile: +98 911 331 0136 Fax: Email: bidabadi@mail.com Web page address:
Sharing plan
regarding the ethical issue
Regarding the ethical issues
regardingRegarding the ethical issueissues
Protocol summary
Study aim
Determining the effect of probiotics for the treatment of essential hypertension in children and adolescents
Design
This is a phase 3 randomized controlled double-blind clinical trial with parallel-group which will be conducted on 66 patients. patients were randomly assigned to groups using randomizer computer software with 4 and 6 block sizes and1: 1 allocation.
Settings and conduct
Children between 7 and 18 years of age with high blood pressure or grade I and II basic HTN referred to the Nephrology Clinic of 17 Shahrivar Children's Center of Rasht, Children's Medical Center of Tehran University, Ali Asghar Children's Center , Mofid Children's Center of Shahid Beheshti University, Namazi Hospital, Semnan Hospital, Zahedan Children's Hospital, Mashhad Children's Hospital will be investigated. In the intervention group, patients received probiotic capsule 2 times a day.Participants in the control group received placebo. Double blinding is done for the participants and the investigator.
Participants/Inclusion and exclusion criteria
Patients with high blood pressure of the 1st and 2nd degree in the age range of 7 to 18 years will be included in the study. Exclusion criteria were known organ damage, active infection, use of probiotics in the 4 months before the study, and previous history of sensitivity to probiotics.
Intervention groups
Intervention group: The contents of a 500 mg probiotic capsule (Milad Pharmed Gostar company under the brand name Prokid) containing 11 strains are dissolved in 10 ml of 5% dextrose water and administered as 0.5 ml/kg twice a day. Its amount will be 20 ml with or without food for 16 weeks.
Control group: Patients in the placebo group will receive 2 bacteria-free capsules filled with maltodextrin daily for four months.
Main outcome variables
The primary outcome is a reduction in systolic blood pressure from baseline to 3 mmHg after 16 weeks of treatment
General information
Reason for update
Due to the request from The Vice-Chancellor of Research
Acronym
IRCT registration information
IRCT registration number:IRCT20200608047689N3
Registration date:2024-07-14, 1403/04/24
Registration timing:prospective
Last update:2025-04-10, 1404/01/21
Update count:3
Registration date
2024-07-14, 1403/04/24
Registrant information
Name
Elham Bidabadi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3372 9104
Email address
bidabadi@mail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-15, 1403/04/25
Expected recruitment end date
2025-07-16, 1404/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of Adjunctive probiotics therapy for the treatment of primary hypertension in children and adolescents: A randomized, double- blind, placebo- controlled trial
Public title
Assessing the effect of Adjunctive probiotics therapy for the treatment of primary hypertension in children and adolescents: A randomized, double- blind, placebo- controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Essential high blood pressure I and II
Age range between 7-18 years
Exclusion criteria:
Active infection
Known organ damage
Use of probiotics in the 3 months prior to the study
Previous history of sensitivity to probiotics
Age
From 7 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was performed by the blocking randomization method. Patients who have inclusion criteria will be assessed using randomizer computer software and randomly assigned with 4 and 6 block sizes with 1: 1 allocation to the two groups of intervention and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher and participants are blind in this study (double blind). The Researcher does not know which participant is in the intervention or control group. The participant does not know whether he/ she is in the intervention or control group. Both groups will receieve capsuls with the same shape and colour with different contents. Intervention and control capsuls will be noted as A and B by a pharmacist unaware about the research and will be given to the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the vice chancellor of Guilan University of Medical Sciences
Street address
Siadati street
City
Rasht
Province
Guilan
Postal code
4144444444
Approval date
2024-06-26, 1403/04/06
Ethics committee reference number
IR.GUMS.REC.1403.152
Health conditions studied
1
Description of health condition studied
Essential (primary) hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Reduction of systolic blood pressure from the baseline value by 3 mm Hg
Timepoint
After 16 weeks of treatment
Method of measurement
Blood pressure measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The contents of a 500 mg probiotic capsule (Milad Pharmed Gostar company under the brand name Prokid) containing 11 strains are dissolved in 10 ml of 5% dextrose water and administered as 0.5 ml/kg twice a day. Its amount will be 20 ml with or without food for 16 weeks.
Category
Treatment - Other
2
Description
Control group: Patients in the placebo group will receive 2 bacteria-free capsules filled with maltodextrin daily for four months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Children's Hospital
Full name of responsible person
Elham Bidabadi
Street address
Siadati Street
City
Rasht
Province
Guilan
Postal code
4144654679
Phone
+98 13 3336 9061
Email
bidabadi@mail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ramyar Farzan
Street address
Siadati
City
Rasht
Province
Guilan
Postal code
4144444444
Phone
+98 13 3333 5820
Email
RESEARCH@GUMS.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
40
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
Rasht University of Medical Sciences
Full name of responsible person
Elham Bidabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
No. 15- 135 ave.- Golsar
City
Rasht
Province
Guilan
Postal code
4144444444
Phone
+98 13 3372 9104
Fax
Email
bidabadi@mail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Elham Bidabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
No. 15- 135 ave.- Golsar
City
Rasht
Province
Guilan
Postal code
4144444444
Phone
+98 13 3372 9104
Fax
Email
bidabadi@mail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Elham Bidabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
No. 15- 135 ave.- Golsar
City
Rasht
Province
Guilan
Postal code
4144444444
Phone
+98 13 3372 9104
Fax
Email
bidabadi@mail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD