Hypertension Center, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Shanxi Bethune Hospital, Taiyuan, Shanxi, China.
Trials. 2022 Feb 24;23(1):178. doi: 10.1186/s13063-022-06086-2.
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.
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.
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.
ClinicalTrials.gov NCT04406129 . Registered on May 28, 2020.
高血压是目前全球发病率和死亡率的主要可改变原因，导致了巨大的健康和经济负担。尽管已经进行了多项关于高血压管理模式和创新治疗策略的研究，但该领域仍存在空白，控制率差反映出缺乏新颖、有效、临床转化的药物或干预措施。最近的动物和人体研究反复证实了微生物组与高血压之间的联系。值得注意的是，我们之前的研究建立了肠道微生物组与血压升高之间的因果关系。因此，提出了通过肠道微生物组干预治疗高血压的假说，并进行了来自健康供体的粪便微生物群移植（FMT）。
将在 120 名 1 级高血压患者中进行一项多中心、随机、安慰剂对照、盲法临床试验，为期 3 个月。所有入组患者将以 1:1 的比例随机分为口服 FMT 胶囊或安慰剂胶囊组，在第 1、7 和 14 天服用，并在第 30、60 和 90 天进行随访。主要终点是从基线到第 30 天的诊室收缩压变化。主要次要终点是 BP 指标，包括从办公室和 24 小时动态血压监测的收缩压和舒张压变化；评估踝臂指数和脉搏波速度；粪便微生物组成和功能分析；粪便和血清代谢组学分析；血糖、血脂和体重指数变化；以及评估不良事件作为安全性的指标。
在我们之前关于肠道微生物组在高血压发病机制中的作用的研究基础上，本研究是临床转化的一个进展，并探索了粪便微生物组移植治疗高血压的潜力。通过多种方法，如宏基因组测序和代谢组学分析，将进一步研究潜在机制，特别是特定微生物或其后生元在血压改善中的作用。
ClinicalTrials.gov NCT04406129。于 2020 年 5 月 28 日注册。
