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Multicenter randomized controlled trial to evaluate the efficacy and safety of probiotic adjunctive therapy for
Elham Bidabadi1, Farahnak Assadi2, Rama Naghshizadian3
1Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.
Insights
Probiotics significantly lowered blood pressure (BP) in children with hypertension when added to standard treatment. This study found probiotics to be safe and effective for pediatric hypertension management.
Area of Science:
- Pediatric Cardiology
- Microbiome Research
- Hypertension Management
Background:
- Probiotics show promise for adult hypertension but their role in childhood hypertension is unclear.
- This study addresses the efficacy and safety of probiotics in pediatric primary hypertension.
Purpose of the Study:
- To evaluate the effectiveness of probiotics as an adjunct therapy for childhood hypertension.
- To assess the safety profile of probiotics in pediatric patients with hypertension.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled trial was conducted in children with primary hypertension.
- Participants received either probiotics plus conventional drugs or antihypertensive drugs alone for 4 months.
- Endpoints included blood pressure reduction and incidence of adverse events.
Main Results:
- The probiotic group showed a greater reduction in both systolic (-4.9 mmHg) and diastolic (-3.3 mmHg) blood pressure compared to the control group.
- Reductions were statistically significant (p=0.02 for systolic, p=0.04 for diastolic).
- No serious adverse events were reported, indicating an acceptable safety profile.
Conclusions:
- Combining probiotics with conventional antihypertensive drugs significantly reduces blood pressure in children with primary hypertension.
- Probiotics offer a safe and effective complementary treatment option for pediatric 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-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 .
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