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

IF 13.8 1区 生物学 Q1 MICROBIOLOGY
Luyun Fan, Junru Chen, Qi Zhang, Jie Ren, Youren Chen, Jinfeng Yang, Lu Wang, Zihong Guo, Peili Bu, Bingpo Zhu, Yanyan Zhao, Yang Wang, Xiaoyan Liu, Wenjie Wang, Zhenzhen Chen, Qiannan Gao, Lemin Zheng, Jun Cai
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Abstract

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 (95% CI, - 8.1 to - 0.58; p = 0.024) mmHg, but this difference did not persist even after repeated intervention. After FMT, shifts in microbial richness and structure were identified and the abundance of the phyla Firmicutes and Bacteroidetes was altered. Decreases in the abundances of Eggerthella lenta, Erysipelatoclostridium ramosum, Anaerostipes hadrus, Gemella haemolysans, and Streptococcus vestibularis and increases in the abundances of Parabacteroides merdae, Prevotella copri, Bacteroides galacturonicus, Eubacterium sp. CAG 180, Desulfovibrio piger, Megamonas hypermegale, Collinsella stercoris, Coprococcus catus, and Allisonella histaminiformans were identified and correlated with office SBP. Those species were also correlated with responding and inversely office SBP-associated metabolites including tyrosine, glutamine, aspartate, phenylalanine, methionine, serine, sarcosine, and/or asparagine.

Conclusions: Safety but unsustainable BP reduction was observed in the first trial of the effects of FMT on hypertension. Additional intervention studies on specific microbes with metabolite-targeting and BP-modulating features are needed. Video Abstract.

粪便微生物群移植治疗高血压:一项探索性、多中心、随机、盲法、安慰剂对照试验。
背景:基于肠道微生物群对高血压发展的贡献,提出了一种涉及粪便微生物群移植(FMT)的治疗高血压的新策略,但其疗效尚未在临床中进行研究。方法:在一项随机、盲法、安慰剂对照临床试验(2021/03-2021/12,ClinicalTrials.gov, NCT04406129)中,从中国7个中心招募高血压患者,并在三次就诊时口服FMT或安慰剂胶囊。患者以1:1的比例随机分为4组,由独立统计学家按中心分层。实施意向治疗原则,因为所有接受至少一项干预的随机参与者都包括在内。主要终点是从基线到第30天就诊时办公室收缩压(SBP)的降低。通过3个月的随访记录不良事件(ae)以评估安全措施。通过探索性分析评估血压、粪便微生物组和血浆代谢组的变化。结果:本研究纳入124例患者(平均年龄43岁,73.4%男性),接受FMT (n = 63)或安慰剂(n = 61)胶囊。经历ae(13例(20.6%)vs. 9例(14.8%),p = 0.39)和主要结局(6.28例(11.83)vs. 5.77例(10.06)mmHg, p = 0.62)的参与者数量在两组之间具有可比性。FMT组在FMT治疗1周后出现收缩压下降,两组间差异为- 4.34 (95% CI, - 8.1至- 0.58;p = 0.024) mmHg,但即使在多次干预后,这种差异也没有持续存在。FMT后,微生物丰富度和结构发生了变化,厚壁菌门和拟杆菌门的丰度发生了变化。经鉴定,长尾蛋杆菌、雷氏弓形双歧杆菌、hadrus厌氧菌、溶血球菌和前庭链球菌的丰度降低,meracobacterides merdae、copri Prevotella、半乳杆菌、CAG 180真杆菌、Desulfovibrio swine、超大单胞菌、Collinsella stercoris、catprococcus catus和Allisonella histaminimans的丰度升高,并与办公室收缩压相关。这些物种也与sbp相关的代谢物相关,包括酪氨酸、谷氨酰胺、天冬氨酸、苯丙氨酸、蛋氨酸、丝氨酸、肌氨酸和/或天冬酰胺。结论:在FMT治疗高血压的第一项试验中,观察到安全但不可持续的血压降低。需要对具有代谢物靶向和bp调节特征的特定微生物进行额外的干预研究。视频摘要。
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来源期刊
Microbiome
Microbiome MICROBIOLOGY-
CiteScore
21.90
自引率
2.60%
发文量
198
审稿时长
4 weeks
期刊介绍: Microbiome is a journal that focuses on studies of microbiomes in humans, animals, plants, and the environment. It covers both natural and manipulated microbiomes, such as those in agriculture. The journal is interested in research that uses meta-omics approaches or novel bioinformatics tools and emphasizes the community/host interaction and structure-function relationship within the microbiome. Studies that go beyond descriptive omics surveys and include experimental or theoretical approaches will be considered for publication. The journal also encourages research that establishes cause and effect relationships and supports proposed microbiome functions. However, studies of individual microbial isolates/species without exploring their impact on the host or the complex microbiome structures and functions will not be considered for publication. Microbiome is indexed in BIOSIS, Current Contents, DOAJ, Embase, MEDLINE, PubMed, PubMed Central, and Science Citations Index Expanded.
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