A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Safety and Efficacy Evaluation of Bifidobacterium Infantis 35624 in Female Subjects With Irritable Bowel Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 362
- 试验地点
- 40
- 主要终点
- The primary efficacy variable was the abdominal pain score
研究概览
简要总结
The purpose of this study was to determine the dose-ranging efficacy and safety profile of encapsulated Bifidobacterium infantis 35624 in female subjects with irritable bowel syndrome (IBS).
详细描述
The pathogenesis of irritable bowel syndrome (IBS) may have a a post-infectious inflammatory component, suggesting that altered gut bacterial flora are of relevance and that probiotics may be beneficial. This clinical trial examined the efficacy of an encapsulated probiotic in subjects with Rome II IBS. After a 2 week baseline, 362 female subjects were randomized to placebo or one of three doses of B. infantis 35624 once daily for 4 weeks. IBS symptoms were monitored daily and scored according to a 6-point Likert scale; stool frequency and form were also monitored daily. The primary efficacy variable was the abdominal pain score; secondary efficacy variables included other IBS symptom relief and quality of life.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meet Rome II criteria for the diagnosis of IBS
- •Refrain from using probiotic supplements during the trial
排除标准
- •Organic diseases, including inflammatory bowel disease, and significant systemic diseases
- •Subjects over 55 years of age that had not had a sigmoidoscopy or colonoscopy performed in the previous five years
- •Use of anti-psychotic medications within the prior three months
- •Had major psychiatric disorder (DSM-II-R or DSM-IV), including major depression, psychoses, alcohol or substance abuse, within the past two years
- •Were pregnant or nursing
- •Had known lactose intolerance or immunodeficiency
- •Had undergone any abdominal surgery, with the exception of hernia repair or appendectomy
结局指标
主要结局
The primary efficacy variable was the abdominal pain score
次要结局
- Bloating/distension, sense of incomplete evacuation, straining, urgency, passage of gas, number of bowel movements, passage of mucus, a composite symptom score, subject's assessment of IBS symptom relief, and quality of life