Systematic review of the orally administered microbiome therapeutic, fecal microbiota spores, live-brpk, to prevent recurrence of Clostridioides difficile infection in adults.

IF 2.3 Q2 MEDICINE, GENERAL & INTERNAL
SAGE Open Medicine Pub Date : 2024-10-09 eCollection Date: 2024-01-01 DOI:10.1177/20503121241274192
Kerry LaPlante, Robert Stevens, Anne J Gonzales-Luna
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引用次数: 0

Abstract

Background: Clostridioides difficile infection (CDI) has been linked to over 200,000 cases of illness in hospitalized patients and over 20,000 deaths annually. Up to 25% of patients with an initial CDI episode will experience recurrent CDI (rCDI), which most commonly occurs in the first 8 weeks following antibiotic therapy. In patients with first or multiple rCDI, infection, the microbiome is similarly disrupted, which highlights the challenges of using antibiotics alone while underscoring the need for microbiome restoration regardless of the number of recurrences. In this systematic review, we describe the role of the gastrointestinal microbiome in CDI, and systematically review fecal microbiota spores, live-brpk (VOWST™; VOS for Vowst Oral Spores) for prevention of recurrence in rCDI.

Methods: The PubMed database was searched using "recurrent Clostridioides difficile infection" AND (SER-109 OR VOS) and limited to clinical trials. The search yielded 7 results: 3 articles describing 3 clinical trials (two Phase 3 trials (ECOSPOR III and ECOSPOR IV) and one Phase 2 trial (ECOSPOR)), 1 describing follow-up of ECOSPOR III, 1 describing a post hoc analysis of comorbidities in ECOSPOR III, and 2 describing health-related quality of life in ECOSPOR III.

Results: Compared with placebo, VOS following standard-of-care antibiotics for CDI significantly reduced risk of recurrence at 8 weeks (relative risk, 0.32 (95% CI: 0.18-0.58); p < 0.001; number needed to treat: 4) with a tolerable safety profile; rCDI rates remained low through 24 weeks. The disrupted microbiome, secondary to/exacerbated by antibiotic treatment, was rapidly (i.e., Week 1) restored with VOS. Compared with placebo, VOS demonstrated greater improvements in health-related quality of life.

Conclusions: Clinical care of patients with rCDI now includes Food and Drug Administration-approved therapeutics to address microbiome restoration. Clinical trial evidence supports use of VOS following antibiotics and importance of microbiome restoration in rCDI.

对口服微生物群疗法--粪便微生物群孢子活体--brpk--预防成人艰难梭菌感染复发的系统综述。
背景:艰难梭菌感染(CDI艰难梭菌感染(CDI)每年导致 20 多万例住院病人发病,2 万多人死亡。多达 25% 的首次 CDI 患者会出现复发性 CDI(rCDI),最常发生在抗生素治疗后的前 8 周。在首次或多次复发性 CDI 感染的患者中,微生物群同样会受到破坏,这凸显了单独使用抗生素所面临的挑战,同时也强调了无论复发次数多少,都需要恢复微生物群。在这篇系统综述中,我们描述了胃肠道微生物群在 CDI 中的作用,并系统综述了用于预防 rCDI 复发的粪便微生物群孢子、活体-brpk(VOWST™;VOS 指 Vowst 口腔孢子):使用 "复发性艰难梭菌感染 "和(SER-109 或 VOS)对 PubMed 数据库进行检索,并仅限于临床试验。搜索结果有 7 项:3篇文章介绍了3项临床试验(2项3期试验(ECOSPOR III和ECOSPOR IV)和1项2期试验(ECOSPOR)),1篇介绍了ECOSPOR III的随访情况,1篇介绍了ECOSPOR III中合并症的事后分析,2篇介绍了ECOSPOR III中与健康相关的生活质量:结果:与安慰剂相比,使用标准护理抗生素治疗 CDI 后的 VOS 可显著降低 8 周后的复发风险(相对风险为 0.32(95% CI:0.18-0.58);P 结论:与安慰剂相比,使用标准护理抗生素治疗 CDI 后的 VOS 可显著降低 8 周后的复发风险:目前,rCDI 患者的临床治疗包括经美国食品和药物管理局批准的用于恢复微生物群的疗法。临床试验证据支持在使用抗生素后使用 VOS,以及恢复 rCDI 微生物群的重要性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
SAGE Open Medicine
SAGE Open Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
3.50
自引率
4.30%
发文量
289
审稿时长
12 weeks
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