Key Laboratory of Dairy Biotechnology and Engineering, Key Laboratory of Dairy Products Processing, Inner Mongolia Key Laboratory of Dairy Biotechnology and Engineering, Inner Mongolia Agricultural University, Ministry of Education, Ministry of Agriculture and Rural Affairs, Hohhot, 010018, China.
Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China.
BMC Gastroenterol. 2022 May 20;22(1):255. doi: 10.1186/s12876-022-02320-y.
For patients with gastro-oesophageal reflux symptoms, the preferred treatment is proton pump inhibitor (PPI) administration for approximately 8 weeks. However, long-term use of PPIs can cause gut microbiome (GM) disturbances. This study is designed to evaluate the effect of probiotics combined with a PPI on the GM and gastrointestinal symptoms of patients with gastro-oesophageal reflux disease (GERD).
This is a randomized, double-blind, placebo-controlled trial. A total of 120 eligible patients with GERD will be randomized into the experimental group or the control group. The treatment includes two phases: the initial treatment period lasts 8 weeks (weeks 1-8), and the maintenance treatment period lasts 4 weeks (weeks 9-12). During the initial treatment period, the experimental group will take rabeprazole and LiHuo probiotics, and the control group will take rabeprazole and a probiotic placebo; during the maintenance treatment period, the experimental group will take LiHuo probiotics, and the control group will take a probiotic placebo. The primary measure is the change in the GM. The secondary measures are the Reflux Disease Questionnaire (RDQ) score, Gastrointestinal Symptom Rating Scale (GSRS) score, faecal metabolome (FM), body mass index, Los Angeles grade of oesophagitis, adverse event (AE) rate and treatment compliance. Each outcome indicator will be assessed at day 0 (before administration), day 28 and/or 56 (during administration), and day 84 (end of administration) to reveal intragroup differences. AEs will be monitored to assess the safety of LiHuo probiotics.
This will be the first trial to use the intestinal flora metagene method to analyse the effects of probiotics on patients with GERD receiving long-term PPI treatment. The goal is to provide evidence for the use of probiotics to reduce intestinal flora disorders and other symptoms of gastrointestinal discomfort in patients with GERD who have used PPIs for a long period.
Chinese Clinical Trial Registry (ChiCTR) (NO. ChiCTR2000038409). Registered on November 22, 2020, http://www.chictr.org.cn/showproj.aspx?proj=56358 .
对于胃食管反流症状患者，首选治疗方法是质子泵抑制剂（PPI）治疗约 8 周。然而，长期使用 PPI 会导致肠道微生物组（GM）紊乱。本研究旨在评估益生菌联合 PPI 对胃食管反流病（GERD）患者 GM 和胃肠道症状的影响。
这是一项随机、双盲、安慰剂对照试验。共有 120 名符合条件的 GERD 患者将被随机分为实验组或对照组。治疗包括两个阶段：初始治疗期持续 8 周（第 1-8 周），维持治疗期持续 4 周（第 9-12 周）。在初始治疗期间，实验组服用雷贝拉唑和活力益生菌，对照组服用雷贝拉唑和益生菌安慰剂；在维持治疗期间，实验组服用活力益生菌，对照组服用益生菌安慰剂。主要测量指标是 GM 的变化。次要测量指标是反流疾病问卷（RDQ）评分、胃肠道症状评分量表（GSRS）评分、粪便代谢组（FM）、体重指数、洛杉矶食管炎分级、不良事件（AE）发生率和治疗依从性。每个结局指标将在第 0 天（给药前）、第 28 天和/或第 56 天（给药期间）以及第 84 天（给药结束）进行评估，以揭示组内差异。将监测不良事件以评估活力益生菌的安全性。
这将是第一项使用肠道菌群元基因组方法分析益生菌对长期接受 PPI 治疗的 GERD 患者的影响的试验。目的是为益生菌的使用提供证据，以减少长期使用 PPI 的 GERD 患者肠道菌群紊乱和其他胃肠道不适症状。
中国临床试验注册中心（ChiCTR）（注册号：ChiCTR2000038409）。于 2020 年 11 月 22 日注册，网址：http://www.chictr.org.cn/showproj.aspx?proj=56358。
