Effect of a probiotic on blood pressure in grade 1 hypertension (HYPRO): protocol of a randomized controlled study

Mähler, Anja; Wilck, Nicola; Rauch, Geraldine; Dechend, Ralf; Müller, Dominik N.

doi:10.1186/s13063-020-04973-0

Cited by 17 publications

(9 citation statements)

References 24 publications

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“…The latter meta-analysis also revealed a threshold of duration (> 8 weeks) and daily dose (probiotics > 10 11 colony-forming units) and a recommendation of multiple bacteria prescribed for effective intervention [33]. Additionally, innovative products such as mixed strains of live bacteria belonging to Lactobacilus and Bifidobacteria are still under trial [44]. Limited evidence of specific microbes causing hypertension prohibits the exploration of microorganism-targeting supplements via prebiotics and/or probiotics or inhibition via antibiotics.…”

Section: Discussionmentioning

confidence: 99%

Effect of fecal microbiota transplantation on primary hypertension and the underlying mechanism of gut microbiome restoration: protocol of a randomized, blinded, placebo-controlled study

Lyu

Ren

Chen

et al. 2022

Trials

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Background Hypertension is currently the leading modifiable cause of global morbidity and mortality, leading to substantial health and financial burdens. Although multiple studies of management models and innovative therapeutic strategies for hypertension have been conducted, there are still gaps in the field, with a poor control rate reflecting a lack of novel, effective, clinically translated medication or intervention options. Recent animal and human studies repeatedly confirmed a link between the microbiota and hypertension. Of note is our previous study establishing a cause-and-effect relationship between the gut microbiota and blood pressure elevation. A hypothesis of gut microbiota intervention for treating hypertension is thus postulated, and fecal microbiota transplantation (FMT) from healthy donors was performed. Methods A multicenter, randomized, placebo-controlled, blinded clinical trial will be performed in 120 grade 1 hypertensive patients for 3 months. All recruited patients will be randomly assigned in a 1:1 ratio to take oral FMT capsules or placebo capsules on day 1, day 7, and day 14 and will be followed up on day 30, day 60, and day 90. The primary outcome is the change in office systolic blood pressure from baseline to day 30. The main secondary outcomes are BP indicators, including changes in systolic and diastolic blood pressure from office and 24-h ambulatory blood pressure monitoring; assessments of ankle-branchial index and pulse wave velocity; profiling of fecal microbial composition and function; profiling of fecal and serum metabolome; changes in levels of blood glucose, blood lipids, and body mass index; and assessment of adverse events as a measure of safety. Discussion Expanding upon our previous research on the role of the gut microbiota in the pathogenesis of hypertension, this study serves as a clinical translation advancement and explores the potential of fecal microbiota transplantation for treating hypertension. The underlying mechanisms, particularly the roles of specific microorganisms or their postbiotics in blood pressure amelioration, will also be investigated via multiple approaches, such as metagenomic sequencing and metabolomic profiling. Trial registration ClinicalTrials.govNCT04406129. Registered on May 28, 2020

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Section: Discussionmentioning

confidence: 99%

Effect of fecal microbiota transplantation on primary hypertension and the underlying mechanism of gut microbiome restoration: protocol of a randomized, blinded, placebo-controlled study

Lyu

Ren

Chen

et al. 2022

Trials

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“…The latter metaanalysis also revealed a threshold of duration(>8 weeks) and daily dose(probiotics >1011 colonyforming units), and a recommendation on multiple bacteria prescribed for effective intervention (34) . As well, innovative products such as mixed strains of live bacteria belongs to Lactobacilus and Bifidobacteria are still under trial (44). Limited evidences on specific microbes causing hypertension prohibit explorations on microorganism-targeting supplement via prebiotics and/or probiotics, or inhibit via antibiotics.…”

Section: Discussionmentioning

confidence: 99%

Effect of Fecal Microbiota Transplantation on Primary Hypertension and the Underlying Mechanism of Gut Microbiome Restoration: Protocol of a Randomized, Double-Blinded, Placebo-Controlled Study

Lyu¹,

Ren²,

Chen³

et al. 2021

Preprint

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BackgroundHypertension is in current the leading modifiable cause of global morbidity and mortality, contributing to substantial health and financial burdens. Although multiple explorations on management models and innovative therapeutic strategies of hypertension, vacancy still occur in the field with poor control rate reflected and lacking of novel, effectively clinical-translated medication or intervention options. Recent animal and human studies repeatedly confirmed a link between microbiota and hypertension. Of note is our previous study establishing a cause-and-effect relationship between gut microbiota and blood pressure elevation. A hypothesis of gut microbiota intervention on treating hypertension is thus postulated with fecal microbiota transplantation(FMT) from healthy donors performed. MethodsA multi-center, central randomized, placebo-controlled, double-blinded clinical trial is performed in 120 grade 1 hypertensive patients for overall three months. All recruited patients will be randomly assigned in a 1:1 ratio into orally-taken FMT capsules or placebo capsules with three interventions on day 1, day 7 and day 14 in separate, and followed up on day 30, day 60 and day 90. The primary outcome is the change for office systolic blood pressure from baseline to day 30 follow-up. Main secondary outcomes are BP indicators including changes in systolic and diastolic blood pressure from office, home, and 24-hour ambulatory blood pressure monitoring, assessments of ankle-branchial index and pulse wave velocity, profiling of fecal microbial composition and function, profiling of fecal and serum metabolome, changes in levels of blood glucose, blood lipids and body mass index, assessment of adverse events as a measure of safety. DiscussionStretching from our previous research on the role of gut microbiota in the pathogenesis of hypertension, this study serves as a clinical translation advancement and firstly explores the potential of fecal microbiota transplantation on treating hypertension. Underlying mechanisms particularly on anchoring specific microorganisms or their postbiotics contributing to blood pressure amelioration will also be investigated via multiple approaches such as metagenomic sequencing and metabolomic profiling.Trial registrationClinicalTrials.gov Identifier: NCT04406129, registried on May 28th, 2020, https://clinicaltrials.gov/ct2/show/NCT04406129

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“…Where this clinical study postulates that the group treated with probiotics bifidobacterial, streptococcus and lactobacillus has converted the dietary components into active metabolites and these metabolites positively affect function of immune cells which in turn could encourage in lowering of blood pressure. 9 The meta-analysis on probiotics for antihypertensive effect from fermented milk has shown a significant effect on systolic and diastolic blood pressure (BP), 10 but during the process of investigation it is observed that the supplemented probiotics significantly affect systolic blood pleasure in patients with hypertension and diabetes, and effect on diastolic blood pressure was observed in patients with only hypertension for short period (8-10) weeks on comparing with the control group. 11 The study by Lewis et al, has supported the use of probiotics supplements for lowering systolic BP -1.58 mmHg, and diabolic BP -0.92 mmHg.…”

Section: Lowering the Blood Pressurementioning

confidence: 99%

Probiotic Intervention in the Treatment of Diabetes Mellitus: A Review

Sreepathi¹,

Jayanthi²,

Chandra³

et al. 2022

J. Pure Appl. Microbiol.

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Diabetes is a noncommunicable lifestyle condition that impacts millions of individuals worldwide. Diabetes is a physiological illness that affects several different organs in the human body. Several studies have found a direct relationship between gut microbiota and diabetes control. Probiotic intervention in the treatment of diabetes mellitus has been the center of focus in the current scenario. Alteration in composition and metabolic activity of gut microbiota significantly contributes to human health. However, the key mechanism of gut microbiota in the inhibition of diabetes is not fully understood. This review discusses the effect of probiotics on diabetes and the role of gut microbiota. It emphasizes on the pharmacological effects of probiotics on diabetic symptoms like glycemic response, hypercholesterolemia, hypertension, as well as gestational diabetes.

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Effect of a probiotic on blood pressure in grade 1 hypertension (HYPRO): protocol of a randomized controlled study

Cited by 17 publications

References 24 publications

Effect of fecal microbiota transplantation on primary hypertension and the underlying mechanism of gut microbiome restoration: protocol of a randomized, blinded, placebo-controlled study

Effect of fecal microbiota transplantation on primary hypertension and the underlying mechanism of gut microbiome restoration: protocol of a randomized, blinded, placebo-controlled study

Effect of Fecal Microbiota Transplantation on Primary Hypertension and the Underlying Mechanism of Gut Microbiome Restoration: Protocol of a Randomized, Double-Blinded, Placebo-Controlled Study

Probiotic Intervention in the Treatment of Diabetes Mellitus: A Review

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