A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients: A Two-Center, Randomized, Double-Blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Frequency of Diarrhea in IBS-D Patients
研究概览
简要总结
The goal of this interventional clinical study is to study whether the consumption of QiMeiYan Probiotics in 25-35 young people with Mild irritable bowel syndrome (IBS Score 75 - 175) will reduce the frequency of Diarrhea.
140 eligible participants (70 males and 70 females) will be enrolled in two study sites and randomly assigned to two groups of products QiMeiYan Probiotics and placebo. All participants will consume assigned products once a day after meals and record the critical data such as photo of feces. Three site visits will be arranged and all clinical data will be captured and recorded into CTMS (Clinical Trial Management System) for statistical analysis.
Researchers will compare the two groups to validate if the daily consumption of QiMeiYan Probiotics will reduce the frequency of Diarrhea in the study population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese males or females, age between 25-35, the ratio is 1:1;
- •Mild irritable bowel syndrome diagnosed by IBS-SSS, IBS Score 75 - 175;
- •Subjects agree not to take any other probiotics during the trial;
- •Willing not to participate in other interventional clinical studies during the period of this trial;
- •Fully understand the purpose, benefits obtained, possible risks and side effects of the study;
- •Willing to comply with all research requirements and procedures;
- •Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate.
排除标准
- •In the treatment of gastrointestinal symptoms;
- •Lactose intolerance;
- •Suffering from other organic diseases currently that affect the intestinal function, such as history, colon or rectal cancer resection of gastrointestinal tract, inflammatory bowel disease, diabetes, thyroid function hyperfunction or decline, congenital megacolon, scleroderma, anorexia, etc.;
- •Controlling diet, exercising more, or taking medications to control weight or affect appetite in the last 3 months;
- •Subjects have any of the following medical history or have been clinically examined to have the following diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases;
- •Abuse alcohol or other drugs, supplement or OTC drugs currently or in the past may cause bowel dysfunction or can affect test result evaluation;
- •Take drugs frequently that may affect gastrointestinal function or the immune system according to PI's judgment;
- •Use laxatives or other substances that promote digestion 2 weeks before the trial;
- •Take dairy products or other foods containing prebiotics/bacteria 10 days before the trial.
结局指标
主要结局
Frequency of Diarrhea in IBS-D Patients
时间窗: baseline day 0, day 28
Frequency of Diarrhea in IBS-D Patients for the two groups of participants during the study period
次要结局
- Change of Score of IBS-SSS(baseline day 0, day14, day 28)
- Change of Bristol Stool Scale of the feces(baseline day 0, day 7, day 14, day 21, day 28)