化便微生物群囊中的细菌多样性,活力和稳定性支持持续的临床使用
Nur Masirah M Zain1, Blair Merrick2, Thomas Martin-Lilley1
1Institute of Pharmaceutical Science, Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.
International journal of pharmaceutics
|May 12, 2025
概括
软化封装便微生物种移植 (FMT) 是对复发性C. difficile感染的可行的治疗方法. 囊通过制造和长期储存来维持细菌的多样性和活力,从而支持它们的有效性.
科学领域:
- 微生物学 微生物学
- 胃肠病学 胃肠病学
- 制药科学 制药科学
背景情况:
- 反复复发的Clostridioides difficile感染 (rCDI) 是一个重大的临床挑战.
- 便微生物群移植 (FMT) 是对rCDI的有效治疗方法.
- 封装,冷化FMT提供了一个实用且潜在的成本效益高的治疗选择.
研究的目的:
- 在一个有肠道涂层的,冷化封装的FMT产品上进行质量保证.
- 在制造和储存过程中评估FMT配方的细菌成分,多样性和活力.
- 评估封装FMT作为药物的稳定性和有效性.
主要方法:
- 从健康捐赠者的便微生物群加工成封装治疗.
- 培养独立的16S rRNA基因测序用于细菌的特异化和定量化.
- 生死细胞分离方法,以确定可活性的细菌负载.
- 在不同温度 (-80°C, -20°C, 2-8°C) 下进行存储稳定性测试,长达36周.
主要成果:
- 供体便中的细菌多样性在整个制造和储存过程中是一致的 (-80°C 36周).
- 排除非活性的细胞显著影响了物种丰富性,突出显示了活性的细菌的重要性.
- 尽管有氧加工,但无氧物种保持了生存能力.
- 封装的FMT在-20°C和2-8°C下24周表现出稳定性,活细菌负载没有显著降低.
结论:
- 活死分析有效地描述了封装的FMT的可活性细菌含量.
- 软化封装的FMT配方通过加工和储存保留了细菌的多样性,包括无氧生物.
- 这些发现支持封装FMT与其他用于rCDI治疗的输送方法的可比效果.
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