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Background <p>Probiotics have emerged as a promising therapeutic strategy for blood pressure control in hypertensive adult patients; however, the efficacy and safety of probiotics in childhood hypertension remain uncertain.</p> Methods <p>We conducted a multicenter, randomized, double-blind, placebo-controlled trial in children with primary hypertension (HTN). Study endpoints included a reduction in absolute systolic or diastolic blood pressure of at least 3.0&#xa0;mmHg and 2.0&#xa0;mmHg, respectively, and the incidence of adverse events during the 4-month study period.</p> Results <p>Sixty-six patients were randomized to receive probiotics plus conventional drugs (study group, <i>n</i> = 33) or antihypertensive drugs alone (control group, <i>n</i> = 33) for 4&#xa0;months. The study group (probiotics plus antihypertensive drugs, <i>n</i> = 33) and the control group (antihypertensive drugs alone, <i>n</i> = 33) had similar demographics, including age, sex, and body mass index. Most patients had stage-1 HTN (66%). The study group had a larger reduction in systolic and diastolic blood pressure (BP) compared to the control group. The mean change in systolic BP was -4.9&#xa0;mmHg; 95%&#xa0;confidence interval [CI], − 6.96 to − 2.84 (study group) vs. -3.1&#xa0;mmHg; 95% CI, − 4.12 to − 2.13 (control group), <i>p</i> = 0.02. For diastolic BP, it was -3.3&#xa0;mmHg; 95%&#xa0;CI (-4.12 to -2.13) (study group) vs. -2.1&#xa0;mmHg; 95%&#xa0;CI, -2.50 to -1.82, <i>p</i> = 0.04 (control group), <i>p</i> = 0.04. The reduction in BP was more significant in children with stage-1 HTN compared to those with stage-2 HTN. No serious adverse events (SAEs) were observed during the trial.</p> Conclusions <p>Probiotics combined with conventional antihypertensive drugs significantly reduced systolic and diastolic BP in children with primary HTN and have an acceptable safety profile.</p> Trial Registration <p>IRCT20200608047689N3, 07/14/2024, <a href="https://irct.behdasht.gov.ir">https://irct.behdasht.gov.ir</a>.</p> Graphical abstract <p></p>

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Multicenter randomized controlled trial to evaluate the efficacy and safety of probiotic adjunctive therapy for children with primary hypertension

  • 期刊论文

  • 发表日期：

    2025年7月28日

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  • Elham Bidabadi,
  • Farahnak Assadi,
  • Rama Naghshizadian,
  • Khaled Rahmani,
  • Afshin Safaei-Asl,
  • Mojgan Mazaheri,
  • Anoush Azarfar,
  • Simin Sadeghi-bojd,
  • Fatemeh Ghane Sharbaf,
  • Arash Abbasi,
  • Hamidreza Badeli,
  • Alireza Eskandarifar

摘要

Background

Probiotics have emerged as a promising therapeutic strategy for blood pressure control in hypertensive adult patients; however, the efficacy and safety of probiotics in childhood hypertension remain uncertain.

Methods

We conducted a multicenter, randomized, double-blind, placebo-controlled trial in children with primary hypertension (HTN). Study endpoints included a reduction in absolute systolic or diastolic blood pressure of at least 3.0 mmHg and 2.0 mmHg, respectively, and the incidence of adverse events during the 4-month study period.

Results

Sixty-six patients were randomized to receive probiotics plus conventional drugs (study group, n = 33) or antihypertensive drugs alone (control group, n = 33) for 4 months. The study group (probiotics plus antihypertensive drugs, n = 33) and the control group (antihypertensive drugs alone, n = 33) had similar demographics, including age, sex, and body mass index. Most patients had stage-1 HTN (66%). The study group had a larger reduction in systolic and diastolic blood pressure (BP) compared to the control group. The mean change in systolic BP was -4.9 mmHg; 95% confidence interval [CI], − 6.96 to − 2.84 (study group) vs. -3.1 mmHg; 95% CI, − 4.12 to − 2.13 (control group), p = 0.02. For diastolic BP, it was -3.3 mmHg; 95% CI (-4.12 to -2.13) (study group) vs. -2.1 mmHg; 95% CI, -2.50 to -1.82, p = 0.04 (control group), p = 0.04. The reduction in BP was more significant in children with stage-1 HTN compared to those with stage-2 HTN. No serious adverse events (SAEs) were observed during the trial.

Conclusions

Probiotics combined with conventional antihypertensive drugs significantly reduced systolic and diastolic BP in children with primary HTN and have an acceptable safety profile.

Trial Registration

IRCT20200608047689N3, 07/14/2024, https://irct.behdasht.gov.ir.

Graphical abstract