综述解读 情报发生 2026-10-31 · 发布于 2026-11-01

PROMISE 试验方案:粪菌移植改善肝硬化结局的随机对照设计

来源:Trials · PMID 42947250 · DOI 10.1186/s13063-026-09914-x · 来源:IMA 知识库《文献层·文献监控卡片》2026-10-31 期 · 全文级(file_id dmlmcfQeUyzO,实际下载核验) · 全文已获取并通过归属校验

时间标签:数据日期 2026-10-31 · 生成时间 2026-11-01 05:30(Asia/Shanghai)| 检索窗口 PubMed edat 2026/10/28–2026/10/31 | 情报发生日期 2026-10-31

研究问题

Furthermore, drug-resistant infections pose a significant challenge in cirrhosis [], with their prevalence increasing from 29 to 38% between 2011 and 2018 [].;However, considerable concern remains regarding the long-term effect of antibiotic prescriptions on AMR [, ].;However, a significant reduction in plasma ammonia between baseline and day-30 was observed in those treated with FMT [].

方法

Secondary objectives:To evaluate the efficacy of encapsulated FMT to reduce non-acute decompensating episodes of cirrhosis including new-onset or worsening grade of ascites and covert hepatic encephalopathy (West Haven criteria grade 0–1) [].To evaluate the impact of encapsulated FMT on patient outcomes including all-cause hospitalisation, disease progression (including development of acute-on-chronic liver failure), quality of life, mental health, alcohol use and survival.To assess the impact of FMT on antibiotic usage and loss/reduction of AMR genes.To evaluate the safety of encapsulated FMT.;Secondary endpoints (over a 24-month follow-up period):Time to first infection resulting in hospitalisation.Incidence of any decompensating episode of cirrhosis, including hepatic encephalopathy, new-onset or worsening ascites or variceal bleeding.Incidence of all-cause infection, including infect

核心结论

It is estimated that 10–20% of the UK population are at risk of developing CLD [].;Overt systemic inflammation with concurrent functional immunodeficiency is exhibited in cirrhosis, a phenomenon termed cirrhosis-associated immune dysfunction (CAID), resulting in an increased propensity to infection and higher likelihood of resultant complications [].;Furthermore, drug-resistant infections pose a significant challenge in cirrhosis [], with their prevalence increasing from 29 to 38% between 2011 and 2018 []. ‖ 结论:Rather than simply increasing microbial diversity, FMT may re-establish key metabolic networks, improve gut barrier integrity and recalibrate immune responses [, , ], mechanisms that may collectively reduce systemic inflammation and the risk of decompensating events.

局限

Further work has revealed that FMT may also increase gut-microbial richness and reduce carriage of enteric pathogens, intestinal barrier damage, and systemic inflammation [].;Patients who undergo liver transplantation will no longer receive IMP due to the lack of robust safety data of FMT administration in immunocompromised patients post liver transplantation.

对本项目的价值

★★☆☆☆ 干预证据决定参照标准效应量——任何抗衰干预的收益至少应对标该基线。设计 double-blind、phase 3。

全文来源

PMC JATS 全文(正文 44,647 字符,已过标题/DOI 逐字归属校验)

原文题录

  • 英文标题:PROMISE: a PROspective randomised double-blind parallel group placebo-controlled multicentre trial of faecal MIcrobiota tranSplantation to improve outcomEs in patients with cirrhosis over 24 months-study protocol for a clinical trial.
  • 期刊与标识:Trials · PMID 42947250 · DOI 10.1186/s13063-026-09914-x

C 级证据分级:C 级(预印本 / 观点评论,非原始研究)

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