Evidence map›Paper›PMID 40719864›Full record

Trial reportPediatric nephrology (Berlin, Germany)2025

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

Elham Bidabadi, Farahnak Assadi, Rama Naghshizadian, Khaled Rahmani, Afshin Safaei-Asl, Mojgan Mazaheri, Anoush Azarfar, Simin Sadeghi-Bojd, Fatemeh Ghane Sharbaf, Arash Abbasi and 2 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Pediatric nephrology (Berlin, Germany), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. The probioticGut microbes · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Elham BidabadiPediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.
Farahnak AssadiDepartment of Pediatrics, Division of Nephrology, Rush University Medical Center, Chicago, IL, 60612, U.S.A.. fassadi@rush.edu.ORCID 0000-0001-5202-036X
Rama NaghshizadianDepartment of Pediatrics, Faculty of Medicine, Besat Hospital, Kurdistan University of Medical Sciences, Sanandaj, Iran.
Khaled RahmaniLiver and Digestive Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran.
Afshin Safaei-AslPediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.
Mojgan MazaheriDepartment of Pediatrics, Semnan University of Medical Sciences, Semnan, Iran.
Anoush AzarfarDepartment of Pediatrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Simin Sadeghi-BojdChildren and Adolescents Health Research Center. Research Institute Diseases of Cellular and Molecular Sciences in Infectious Zahedan University of Medical Sciences Zahedan, Iran, Zahedan, Iran.
Fatemeh Ghane SharbafDepartment of Pediatrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Arash AbbasiPediatric Chronic Kidney Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Hamidreza BadeliPediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.
Alireza EskandarifarDepartment of Pediatrics, Faculty of Medicine, Besat Hospital, Kurdistan University of Medical Sciences, Sanandaj, Iran.

Funding

Guilan University of Medical Sciences, Rasht, Iran
6 · The paper itself

Abstract

backgroundProbiotics 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.

methodsWe 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.

resultsSixty-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.

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

trial registrationIRCT20200608047689N3, 07/14/2024, https://irct.behdasht.gov.ir .

Indexed as

Antihypertensive AgentsEssential HypertensionHypertensionProbioticsAdolescentBlood PressureChildChild, PreschoolDouble-Blind MethodFemaleHumansMaleTreatment OutcomeAntihypertensive AgentsAntihypertensive treatmentEfficacyMicrobiomePediatric primary hypertensionProbiotics, Safety

Identifiers

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.