Multicenter Randomized Controlled Trial to Evaluate the Efficacy and Safety of Probiotic Adjunctive Therapy for Children With Primary Hypertension Publisher



E Bidabadi ELHAM ; Fk Assadi F K ; R Naghshizadian RAMA ; Kh Rahmani Kh H ; A Safaeiasl AFSHIN ; M Mazaheri MOJGAN ; A Azarfar ANOUSH ; Ss Bojd Simin SADEGHI ; F Ghanesharbaf FATEMEH ; A Abbasi ARASH
Source: Pediatric Nephrology Published:2025

Abstract

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. © 2025 Elsevier B.V., All rights reserved.