Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With Diarrhoea-predominant Irritable Bowel syndrome-a Multicentre Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- the IBS symptom grade score
研究概览
简要总结
We will use the latest Rome IV criteria to recruit IBS-D patients and evaluate the effects of repeated treatment with rifaximin and sequential treatment with rifaximin and probiotics on different symptoms and quality of life. High-throughput sequencing combined with real-time quantitative PCR will be used to comprehensively analyze the effects of different drugs on intestinal flora. The study has important guiding significance for the treatment of patients with IBS-D.
详细描述
According to the Rome IV diagnostic criteria, 200 patients with with diarrhoea-predominant irritable bowel syndrome (IBS-D) from the multi-center (8 units in the country) will be enrolled. The IBS Severity Inventory (IBS-SSS) and IBS Quality of Life Scores (QOL) will be used to evaluate the effect of treatments. Retreatment patients who are initially treated and not satisfied with the improvement of symptoms and quality of life will be treated with Rifaximin for 2 weeks. Fecal specimens will be collected from patients who responded to treatment, and the fecal bacteria will be analyzed by real-time polymerase chain reaction (PCR) using 16 S ribosomal ribonucleic acid (rRNA) gene. Patients who responded to Rifaximin treatment will be randomized into A (Probiotics group) and B (Placebo group). IBS symptom grade score and quality of life score will be evaluated before and after treatment, and fecal specimens of the responding patients will be collected for intestinal probiotics and harmful bacteria detection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old;
- •in line with the diagnostic criteria of diarrhea-type irritable bowel syndrome Roman IV；
- •blood routine, blood biochemistry, stool examination and colonoscopy within 2 years are no problem;
- •no intestinal warning symptoms
排除标准
- •suffering from severe heart, lung, liver, kidney, nervous system diseases;
- •suffering from mental disorders caused by schizophrenia, brain organic and physical diseases;
- •suffering from other diseases that may affect intestinal function (such as diabetes, thyroid disease);
- •History of previous abdominal surgery (excluding history of cholecystectomy or appendectomy);
- •pregnant or lactating women;
- •have undergone colonoscopy in the past month or accept other bowel preparation operations;
- •In the past 1 month, have used antibiotics, antidiarrheal agents, intestinal flora regulation, Chinese medicine and other drugs;
- •have participated in other dietary treatments;
- •understand communication barriers, unable to communicate
研究组 & 干预措施
Rifaximin group
Repeating treatment of Rifaximin
干预措施: Rifaximin (Drug)
Probiotics group
Sequential treatment of probiotics called Bacillus subtilis and Enterococcus faecium
干预措施: Probiotic Formula (Drug)
Placebo group
Placebo control group
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
the IBS symptom grade score
时间窗: 12 weeks
The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score
the quality of life score
时间窗: 12 weeks
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota
时间窗: 2 weeks
16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community
次要结局
未报告次要终点