The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Constipation severity score which measures overall signs and symptoms of constipation using the 'Chinese Constipation Questionnaire' or CCQ (Chan et al, 2005)
研究概览
简要总结
The purpose of this study is to determine the effects of daily consumption for 4 weeks of a fermented milk drink containing a live probiotic microorganism, Lactobacillus casei strain Shirota (LcS) compared to a placebo without LcS, among adults with functional constipation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with functional constipation based on ROME II criteria
- •Has a constipation severity score (Chinese Constipation Questionnaire or CCQ score) of at least 5, which is the cut-off point for constipated subjects (Chan et al, 2005)
- •Free of any cardiovascular related diseases, diabetes, cancer, neurological diseases or any other serious illness, not physically or mentally handicapped
- •Living in Klang Valley, with no pre-determined plans to be out of town for one week or longer during scheduled intervention period
排除标准
- •Body Mass Index of less than 16, or 30 and above
- •Regular ingestion of probiotic products within the preceding four weeks
- •Regular use of laxatives (average once a week or more)
- •Intake of anticholinergics medications or medications against diarrhea or antibiotics in the preceding 1 month
- •Persons with milk protein allergy
- •Persons with constipation of organic or neurological origin based on health screening
- •Persons with alarm features as assessed by physician during health screening
结局指标
主要结局
Constipation severity score which measures overall signs and symptoms of constipation using the 'Chinese Constipation Questionnaire' or CCQ (Chan et al, 2005)
时间窗: 4 weeks
Constipation severity score is patient self-assessment of 6 signs and symptoms of constipation: 1. Severity of false alarms 2. Frequency of less than 3 defecations / week 3. Severity of sensation of incomplete bowel movement 4. Severity of lumpy or hard stools 5. Severity of bloating 6. Frequency of laxative use
Frequency of bowel movement
时间窗: 4 weeks
次要结局
- Stool consistency based on modified Bristol Stool scale(4 weeks)
- Stool output quantity estimations(4 weeks)