8周Bifidobacterium lactis HN019补充剂对功能性便秘的影响:一个多中心,三重盲,随机,安慰剂控制的试验
Reeta Ala-Jaakkola1, Sofia D Forssten1, Jing Cheng1
1Health Sciences, International Flavors & Fragrances, Kantvik, Finland.
每日补充Bifidobacterium lactis HN019并没有改善功能性便秘 (FC) 的成年人肠道运动频率. 这项为期8周的试验与安慰剂相比没有发现显著差异,尽管益生菌耐受性良好.
科学领域:
- 胃肠病学 胃肠病学
- 微生物学 微生物学
- 临床营养学 临床营养学
背景情况:
- 功能性便秘 (FC) 呈现为困难,不经常或不完整的肠道运动,没有明确的生理原因.
- Bifidobacterium lactis HN019 (HN019) 之前已经显示出改善肠道规律性的潜力.
- 罗马III标准定义了功能性胃肠道疾病的诊断标准,包括FC.
研究的目的:
- 评估8周HN019补充剂在增加FC的成年人完全自发排便 (CSBMs) 的疗效.
- 评估二次结果,包括便的一致性,紧张,腹痛,胀气和生活质量.
主要方法:
- 一个三重盲目的,随机的,安慰剂控制的试验,涉及被诊断患有FC的成年人.
- 在2周查期后,参与者每天接受HN019或安慰剂8周.
- 测量结果包括CSBM频率,便特征,症状严重程度 (PAC-SYM,PAC-QoL) 和救援药物的使用.
主要成果:
- 在改善FC成年人中CSBM频率方面,HN019补充剂并不优于安慰剂.
- 在HN019和安慰剂组之间,在便一致性,紧张,疼痛,胀气或生活质量方面没有发现显著差异.
- 便分析 (微生物群,代谢物,calprotectin) 没有显示出显著的群体差异.
结论:
- 这项研究没有支持B. lactis HN019用于改善功能性便秘的成年人中CSBM频率.
- 补充HN019证明了有利的安全概况,没有报告的不良事件.
- 可能需要进一步的研究来探索特定的益生菌菌株或不同种群用于FC管理.
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