Liu Wenjun, Lu Nong-Hua, Zhou Xu, Li Yingmeng, Xie Yong, Zheng Longjin, Zhu Weifeng, Xiao Qiuping, Yang Ni, Zuo Kexuan, Xu Tielong, Zhang Heping
Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education, Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs, Inner Mongolia Key Laboratory of Dairy Biotechnology and Engineering, Inner Mongolia Agricultural University, Hohhot, 010018, China.
Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China.
Contemp Clin Trials Commun. 2023 Feb 1;32:101085. doi: 10.1016/j.conctc.2023.101085. eCollection 2023 Apr.
Probiotics may be an ideal choice for these patients, given it can improve the defecation and quality of life of individuals with chronic diarrhoea. However, evidence-based medical research is still limited to support its use as a diarrhoea agent.
A randomized, double-blind, placebo-controlled clinical trial is designed to pinpoint the efficiency and possible action modes of probiotics for chronic diarrhoea. 200 eligible volunteers with chronic diarrhoea are randomly assigned to a probiotic group (orally taking p9 probiotics powder) or a placebo group. Except an independent project administrator who will be responsible for unblinding, the other researchers are blinded. Primary outcome is diarrhoea severity score, and secondary outcomes include weekly mean frequency of defecation, weekly mean stool appearance score, weekly mean stool urgency score, emotional state score, gut microbiome, and faecal metabolome. Each outcome measure will be assessed at the timepoints of pre-administration (day 0), administration (day 14 and/or 28), and post-administration (day 42) to identity inter- and intra-groups differences. Adverse events will be recorded to evaluate the safety of p9.
The study protocol will provide high-quality evidence for the use of probiotics as a diarrhoea agent when it is strictly conducted out, providing evidence regarding whether and to what extent p9 can improve the defecation and well-being of individuals with chronic diarrhoea.
Chinese Clinical Trial Registry (ChiCTR) (NO. ChiCTR2000038410). Registered on November 22, 2020, https://www.chictr.org.cn/showproj.aspx?proj=56542.
鉴于益生菌可改善慢性腹泻患者的排便情况及生活质量，对这些患者而言，益生菌可能是理想之选。然而，循证医学研究仍有限，不足以支持将其用作治疗腹泻的药物。
设计一项随机、双盲、安慰剂对照临床试验，以明确益生菌治疗慢性腹泻的疗效及可能的作用方式。200名符合条件的慢性腹泻志愿者被随机分为益生菌组（口服p9益生菌粉）和安慰剂组。除负责揭盲的独立项目管理人员外，其他研究人员均处于盲态。主要结局为腹泻严重程度评分，次要结局包括每周平均排便次数、每周平均粪便外观评分、每周平均排便急迫感评分、情绪状态评分、肠道微生物群和粪便代谢组。每个结局指标将在给药前（第0天）、给药期间（第14天和/或第28天）和给药后（第42天）进行评估，以确定组间和组内差异。记录不良事件以评估p9的安全性。
若严格按照研究方案进行，将为益生菌用作治疗腹泻的药物提供高质量证据，证明p9能否以及在何种程度上改善慢性腹泻患者的排便情况和健康状况。
中国临床试验注册中心（ChiCTR）（注册号：ChiCTR2000038410）。于2020年11月22日注册，网址：https://www.chictr.org.cn/showproj.aspx?proj=56542 。
