Protocol summary
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Study aim
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Determining the effect of probiotics for the treatment of essential hypertension in children and adolescents
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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The primary outcome is a reduction in systolic blood pressure from baseline to 3 mmHg after 16 weeks of treatment
General information
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Reason for update
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Due to the request from The Vice-Chancellor of Research
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Acronym
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IRCT registration information
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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
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Registration date
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2024-07-14, 1403/04/24
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2024-07-15, 1403/04/25
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Expected recruitment end date
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2025-07-16, 1404/04/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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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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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 7 years old to 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
66
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-06-26, 1403/04/06
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Ethics committee reference number
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IR.GUMS.REC.1403.152
Health conditions studied
1
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Description of health condition studied
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Essential (primary) hypertension
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ICD-10 code
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I10
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ICD-10 code description
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Essential (primary) hypertension
Primary outcomes
1
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Description
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Reduction of systolic blood pressure from the baseline value by 3 mm Hg
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Timepoint
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After 16 weeks of treatment
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Method of measurement
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Blood pressure measurement
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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Control group: Patients in the placebo group will receive 2 bacteria-free capsules filled with maltodextrin daily for four months.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Rasht University of Medical Sciences
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Proportion provided by this source
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40
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Regarding the ethical issues
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available