NCT03100851已完成3 期
Effect of Fermented Milk Containing Lactobacillus Casei Strain Shirota on Chinese People With Constipation
China Agricultural University0 个研究点目标入组 62 人开始时间: 2015年8月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- change of constipation-related symptom scores
研究概览
简要总结
Constipation is a prevalent intestinal disorder. Lactobacillus casei strain Shirota (LcS) shows potential effect on alleviating constipation. This study evaluated the impact of fermented milk containing LcS on stool consistency and frequency. The stool short chain fatty acid and gut microbiota were also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meet ROME Ⅲ criteria for functional constipation
- •normal body mass index between 18.5 and 29.9
排除标准
- •had a serious disease;
- •used systemic antibiotics or antimycotics medication and antidiarrheal or laxative medication in the 30 days prior to the study;
- •allergic to milk protein;
- •constipated because of organic or neurological lesions;
- •participated in any other studies within 2 months prior to this study.
结局指标
主要结局
change of constipation-related symptom scores
时间窗: change from baseline constipation-related symptom scores at four-week intervention
change of stool consistency
时间窗: change from baseline stool consistency at four-week intervention
change of defecation frequency
时间窗: change from baseline defecation frequency at four-week intervention
次要结局
- Changes in stool short chain fatty acid content(change from baseline stool short chain fatty acid content at four-week intervention)
- Changes in gut microbiota(change from baseline gut microbiota at four-week intervention)
研究者
Fazheng Ren
Professor
China Agricultural University
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