Randomised Controlled Trial: Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- A Change in Abdominal Pain Severity
研究概览
简要总结
In patients with IBS, will supplementation with a probiotic demonstrate symptomatic efficacy and will the probiotic influence gut microflora and thus improve clinical outcomes, as compared to no intervention.
详细描述
Conduct a study on nutrient intakes gastrointestinal microbiota and the effect of a probiotic, Lactobacillus plantarum 299v in irritable bowel syndrome patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fulfillment of the Rome II criteria for IBS,
- •availability of at least one colonoscopy within the last three years,
- •aged 18 or older at the time of screening,
- •provision of written informed consent,
- •commitment of availability throughout the 12 week study period.
排除标准
- •major abdominal surgery in the past other than other than appendectomy, caesarean section, tubal laparoscopic cholecystectomy, abdominal wall hernia repair or/and hysterectomy,
- •current use of antibiotics,
- •history of organic intestinal disease,
- •pregnant or breastfeeding mothers,
- •chronic infectious disease like HIV or tuberculosis, and
- •unable to understand English or Afrikaans.
研究组 & 干预措施
Lactobacillus plantarum 299v
Lactobacillus plantarum 299v capsules
干预措施: Lactobacillus plantarum 299v (Drug)
Lactobacillus plantarum 299v
Lactobacillus plantarum 299v capsules
干预措施: Run in period (Other)
Lactobacillus plantarum 299v
Lactobacillus plantarum 299v capsules
干预措施: Wash - out period (Other)
Crytalline cellulose powder
Placebo capsule, filled with micro-crystalline cellulose powder
干预措施: Placebo comparator (Drug)
Crytalline cellulose powder
Placebo capsule, filled with micro-crystalline cellulose powder
干预措施: Run in period (Other)
Crytalline cellulose powder
Placebo capsule, filled with micro-crystalline cellulose powder
干预措施: Wash - out period (Other)
结局指标
主要结局
A Change in Abdominal Pain Severity
时间窗: Total trial period 12 weeks
The clinical severity of the IBS symptoms (pain and distension) was evaluated by the Francis Severity Score questionnaire (Francis 1997). The questionnaire is a validated tools for use in IBS. The severity score contained five questions, each given a value from 0 (no symptoms) to 100 (most severe) for measuring the severity and frequency of abdominal pain. The sum of scores of these questions was considered the severity score, with a maximum possible score of 500
次要结局
未报告次要终点
研究者
Cheryl Stevenson
Mrs
University of Stellenbosch