Multicenter randomized controlled trial to evaluate the efficacy and safety of probiotic adjunctive therapy for children with primary hypertension.
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-control...
| Publicado en: | Pediatric Nephrology Vol. 40; no. 12; pp. 3707 - 3716 |
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| Autores principales: | , , , , , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Springer Nature
Dec2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=188853864&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 188853864 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 0931041X EF1 jtl: Pediatric Nephrology issn: 0931041X maglogo: N pubinfo: dt: Dec2025 vid: 40 iid: 12 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 188853864 186949007 188853864 188853864 10.1007/s00467-025-06866-3 188853864 ppf: 3707 ppct: 9 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Multicenter randomized controlled trial to evaluate the efficacy and safety of probiotic adjunctive therapy for children with primary hypertension. aug: au: Bidabadi, Elham Assadi, Farahnak Naghshizadian, Rama Rahmani, Khaled Safaei-Asl, Afshin Mazaheri, Mojgan Azarfar, Anoush Sadeghi-bojd, Simin Ghane Sharbaf, Fatemeh Abbasi, Arash Badeli, Hamidreza Eskandarifar, Alireza affil: https://ror.org/04ptbrd12 Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran sug: subj: Hypertension Drug Therapy Antihypertensive Agents Therapeutic Use Probiotics Therapeutic Use Neoadjuvant Therapy Drug Efficacy Patient Safety Human Male Female Child Adolescence Iran United States Multicenter Studies Double-Blind Studies Randomized Controlled Trials Random Assignment Chi Square Test Fisher's Exact Test Analysis of Covariance Multiple Logistic Regression Data Analysis Software Blood Pressure Determination Medication Compliance Descriptive Statistics Blood Pressure Drug Effects Gut Microbiota Drug Effects Hypertension Prevention and Control Funding Source Child: 6-12 years Adolescent: 13-18 years Male Female ab: 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. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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