Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D): A Multicenter, Randomized, Prospective, Placebo-Controlled, Double-Blind, Phase IV Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Change in Abdominal Pain
研究概览
简要总结
The purpose of the study is to monitor safety and to evaluate the efficacy of a probiotic formulation on abdominal pain, abnormal defecation, comorbid mood disorders (anxiety and depression) as well as general quality of life in adults with IBS-D.
详细描述
To monitor safety and to evaluate the efficacy of a probiotic formulation on severity of gastrointestinal symptoms (abdominal pain, abnormal defecation), anxiety, depression and quality of life in adult participants with IBS-D.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Experiencing symptoms of IBS-D
- •Having a diagnosis of IBS-D based on Rome IV criteria
- •Participants with symptom onset at least 6 months before diagnosis
- •Having a normal colonoscopy result in their medical file
排除标准
- •A history of inflammatory or immune-mediated gastrointestinal diseases
- •Diagnosed with a co-existing organic gastrointestinal disease which can affect the study
- •Currently undergoing a treatment for other severe conditions such as coronary disease, neurological disorder, kidney or liver disease,
- •Currently diagnosed with an eating disorder,
- •Having undergone any abdominal surgery including cholecystectomy, with the exception of hernia repair or appendectomy
- •Currently diagnosed with any mood- or anxiety-related disorder, major psychiatric illness, or participants with a history of suicidal ideation, or current suicidal ideation,
- •Regular use of anti-diarrhea medications and laxatives however occasional use is permitted (≤ than once a month); if current use is > once per month a one month wash out is needed,
- •Unwilling to avoid the use of antidiarrheal or laxative medication on an "as-needed basis" during the full length of the study,
- •Pregnant, breast-feeding or planning on becoming pregnant.
研究组 & 干预措施
Intervention
Participants in this group will be randomized to receive probiotic formulation for the following 8 weeks.
干预措施: Probiotic formulation (Drug)
Control
Participants in this group will be randomized to receive placebo for the following 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Abdominal Pain
时间窗: 8 weeks
Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)
Change in Defecation consistency
时间窗: 8 weeks
Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)
次要结局
- Stool frequency(up to 10 weeks)
- Change Abdominal pain intensity(up to 10 weeks)
- Abdominal discomfort(up to 10 weeks)
- Perceived Stress(8 weeks)
- Change in Irritable Bowel Syndrome Symptom Severity Scores(8 weeks)
- Abnormal defecation consistency(up to 10 weeks)