安全性和耐受性ShigActiveTM,一个Shigella spp. 针对细菌准备,在第一阶段随机,双盲,受控临床试验中
Wilbur H Chen1, Joelle Woolston2, Silvia Grant-Beurmann3
1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD 21201, USA.
Antibiotics (Basel, Switzerland)
|September 28, 2024
概括
在一期临床试验中,ShigActiveTM是一种新型细菌治疗石病的新型细菌疗法,被发现是安全的,耐受性良好. 与安慰剂相比,这种治疗没有显著的不良影响,为抗击细菌性胃肠道感染提供了潜在的新方法.
科学领域:
- 微生物学 微生物学
- 胃肠病学 胃肠病学
- 临床试验 临床试验
背景情况:
- 滋格拉菌种导致全球显著的发病率和死亡率,特别是在儿童中,常规治疗选择有限.
- 石病是一种严重的腹性疾病,由于抗菌素耐药性和疫苗限制,它对预防和治疗提出了挑战.
- 菌体治疗为治疗细菌感染提供了潜在的替代方案,包括由Shigella引起的细菌感染.
研究的目的:
- 为了评估ShigActiveTM的安全性和耐受性,ShigActiveTM是一种向Shigella spp.的菌体制剂.
- 评估对胃肠道炎症媒介和便微生物群的不良事件和潜在影响.
- 确定ShigActiveTM作为人类临床环境中的治疗剂的可行性.
主要方法:
- 进行了一项随机的,安慰剂控制的,双盲的第一期临床试验.
- 十名参与者接受了ShigActiveTM或安慰剂口服与二碳酸7天.
- 副作用,炎症标志物和微生物组变化被监测了90天.
主要成果:
- 50%的ShigActiveTM接受者报告了轻微的胃肠道症状;一个人经历了中度疲劳.
- 在第90天之前,没有观察到严重或医疗相关的不良事件.
- 两组之间或从基线检测到的炎症媒介或便微生物组组成没有显著差异.
结论:
- 第一个人体试验表明,ShigActiveTM在口服时是安全的,耐受性很好.
- 与安慰剂相比,ShigActiveTM没有显著的不良影响,支持其作为石病治疗的潜力.
- 需要进一步的研究来探索ShigActiveTM在治疗石病的疗效.
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