Rågård Nina, Baumwall Simon Mark Dahl, Paaske Sara Ellegaard, Hansen Mette Mejlby, Høyer Katrine Lundby, Mikkelsen Susan, Erikstrup Christian, Dahlerup Jens Frederik, Hvas Christian Lodberg
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Therap Adv Gastroenterol. 2025 Feb 8;18:17562848251314820. doi: 10.1177/17562848251314820. eCollection 2025.
Faecal microbiota transplantation (FMT) is increasingly used for diseases associated with a disrupted intestinal microbiome, mainly infection. Encapsulated FMT is a patient-friendly application method that improves accessibility and convenience. Capsule processing may be standardised, but validation protocols are warranted. This review aimed to describe published validation methods for encapsulated FMT. Original studies reporting using encapsulated faecal formulations were included, regardless of indication. Studies were excluded if they did not address processing and validation or used non-donor-derived content. We conducted a comprehensive scoping review, implementing a systematic search strategy in PubMed, Embase and Web of Science. Processing data and validation methods were registered during full-text analysis and combined to create an overview of approaches for assessing quality in encapsulated FMT processing. The searches identified 324 unique studies, of which 44 were included for data extraction and analysis. We identified eight validation covariables: donor selection, pre-processing, preservation, oxygen-sparing processing, microbial count, viability, engraftment and clinical effect outcomes, from which we constructed a model for quality assessment of encapsulated FMT that exhaustively categorised processing details and validation measures. Our model comprised three domains: (1) Processing (donor selection and processing protocol), (2) Content analysis (microbiota measures and dose measures) and (3) Clinical effect (engraftment and clinical outcomes). No studies presented a reproducible capsule protocol; their validation strategies were sparse and divergent. The validation of FMT capsules is heterogeneous, and processing requires relevant standardisation protocols, mainly focusing on capsule content. Future studies should report validation covariables to enable accurate comparative assessments of clinical effects.
粪便微生物群移植（FMT）越来越多地用于治疗与肠道微生物群紊乱相关的疾病，主要是感染。胶囊型FMT是一种对患者友好的应用方法，提高了可及性和便利性。胶囊加工可以标准化，但仍需验证方案。本综述旨在描述已发表的胶囊型FMT验证方法。纳入了报告使用胶囊型粪便制剂的原始研究，无论其适应症如何。如果研究未涉及加工和验证或使用非供体来源的内容，则将其排除。我们进行了一项全面的范围综述，在PubMed、Embase和Web of Science中实施了系统的检索策略。在全文分析过程中记录加工数据和验证方法，并将其合并以创建评估胶囊型FMT加工质量方法的概述。检索确定了324项独特研究，其中44项纳入数据提取和分析。我们确定了八个验证协变量：供体选择、预处理、保存、无氧加工、微生物计数、活力、植入和临床效果结果，据此构建了一个胶囊型FMT质量评估模型，该模型详尽地分类了加工细节和验证措施。我们的模型包括三个领域：（1）加工（供体选择和加工方案），（2）内容分析（微生物群测量和剂量测量）和（3）临床效果（植入和临床结果）。没有研究提出可重复的胶囊方案；其验证策略稀少且不一致。FMT胶囊的验证是异质性的，加工需要相关的标准化方案，主要侧重于胶囊内容物。未来的研究应报告验证协变量，以便能够对临床效果进行准确的比较评估。
