Fecal microbiota transplantation for hypertension: an exploratory, multicenter, randomized, blinded, placebo-controlled trial

作者：Luyun Fan, Junru Chen, Qi Zhang, Jie Ren, Youren Chen, Jinfeng Yang, Lu Wang, Zihong Guo, Peili Bu, Bingpo Zhu, Yan-Yan Zhao, Yang Wang, Xiaoyan Liu, Wenjie Wang, Zhenzhen Chen, Qiannan Gao, Lemin Zheng, Jun Cai · 发表于：Microbiome · 年份：2025 · DOI：10.1186/s40168-025-02118-6 · 被引用次数：38 · 研究领域：Gut microbiota and health、Clostridium difficile and Clostridium perfringens research、Gastrointestinal motility and disorders

BACKGROUND: On the basis of the contribution of the gut microbiota to hypertension development, a novel strategy involving fecal microbiota transplantation (FMT) has been proposed to treat hypertension, but its efficacy has not been investigated in the clinic. METHODS: In a randomized, blinded, placebo-controlled clinical trial (2021/03-2021/12, ClinicalTrials.gov, NCT04406129), hypertensive patients were recruited from seven centers in China, and received FMT or placebo capsules orally at three visits. The patients were randomized at a 1:1 ratio in blocks of four and stratified by center by an independent statistician. The intention-to-treat principle was implemented, as all randomized participants who received at least one intervention were included. The primary outcome was the decrease in office systolic blood pressure (SBP) from baseline to the day 30 visit. Adverse events (AEs) were recorded through the 3-month follow-up to assess safety measures. Alterations in BP, the fecal microbiome, and the plasma metabolome were assessed via exploratory analyses. RESULTS: This study included 124 patients (mean age 43 years, 73.4% men) who received FMT (n = 63) or placebo (n = 61) capsules. The numbers of participants who experienced AEs (13 (20.6%) vs. 9 (14.8%), p = 0.39) and the primary outcome (6.28 (11.83) vs. 5.77 (10.06) mmHg, p = 0.62) were comparable between the groups. The FMT group presented a decrease in SBP after 1 week of FMT, with a between-arm difference of - 4.34 (9...