包膜粪便微生物群的移植：研究进展和未来趋势

摘要(中文译文)

粪菌移植（FMT）在治疗肠道疾病方面显示出显著疗效，如复发性艰难梭菌感染（rCDI）。然而，传统FMT依赖于侵入性递送方式（如结肠镜检查或使用鼻肠管），且缺乏标准化的供体筛查，限制了其广泛的临床采用和可扩展性。作为活体生物治疗产品（LBPs）的一种关键制剂形式，胶囊化FMT代表了从经验性微生物移植向工程化生物治疗的转变，为临床应用提供了更安全、更便捷的途径。本综述以叙述性方式综合、比较和整合了来自PubMed和中国国家知识基础设施的数据。成人胶囊化FMT的研究已朝着标准化和新适应症探索的方向发展。相比之下，儿科研究仍主要集中于rCDI治疗，且缺乏大规模随机对照试验。向胶囊化、标准化产品的演进正推动从全群落微生物制剂向更明确的菌群组合、并最终向基于合成生物学的创新转变。与此同时，重大监管挑战持续存在，因为LBPs的定义仍不一致，明确、协调的国际指南尚未建立。本综述总结了胶囊化FMT的进展和新兴研究重点，同时考察了LBP框架内当前的监管挑战和创新方向。未来发展有望推动胶囊化FMT从全群落移植向功能性微生物菌群的精准调控迈进。这一进展将有助于推动微生物治疗朝着更高程度的标准化和个性化方向发展，为肠道及其他微生物组相关疾病提供改进的治疗策略。

Abstract

Fecal microbiota transplantation (FMT) demonstrates significant efficacy in treating intestinal disorders, such as recurrent Clostridioides difficile infection (rCDI). However, traditional FMT relies on invasive delivery methods (e.g., colonoscopy or use of a nasoenteric tube) and lacks standardized donor screening, limiting its widespread clinical adoption and scalability. As a key formulation of live biotherapeutic products (LBPs), encapsulated FMT represents a transition from empirical microbial transfer to engineered biotherapeutics, offering a safer and more convenient approach for clinical application. This review synthesizes, compares, and integrates data in a narrative fashion from PubMed and the China National Knowledge Infrastructure. Research on encapsulated FMT in adults has progressed toward standardization and the exploration of new indications. In contrast, pediatric studies remain primarily focused on rCDI treatment and lack large-scale randomized controlled trials. Evolution toward encapsulated, standardized products is driving a shift from whole-community microbial formulations toward more defined consortia and, ultimately, synthetic biology-based innovations. Concurrent significant regulatory challenges persist, as definitions of LBPs remain inconsistent and clear, harmonized international guidelines are yet to be established. This review summarizes progress and emerging research priorities in encapsulated FMT while also examining current regulatory challenges and innovative directions within the LBP framework. Future developments are poised to advance encapsulated FMT from whole-community transplantation toward the precise modulation of functional microbial consortia. This progression will help drive microbial therapeutics toward greater standardization and personalization, offering improved treatment strategies for intestinal and other microbiome-associated diseases.

如何引用

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