Evaluation of the Effect of Changyou Probiotic Flavored Yogurt on Intestinal Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Gastrointestinal health score
研究概览
简要总结
This was a randomized, double-blind, single-center, placebo-controlled, three-arm study.
The objectives of this study were to evaluate the effect of the Bright Changyou Probiotic Flavored Yogurt on:
Improving gastrointestinal health; Relieving symptoms of functional constipation or functional diarrhea; Improving gut immunity; Adjusting microbiological flora in gastrointestinal tract.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women aged 25-45 years old;
- •Functional constipation or diarrhea diagnosed by Rome III criteria;
- •Agree not to take any dietary supplements or dairy products other than the study products during the study period;
- •Agree not to take any supplements or dairy products containing prebiotics/probiotics other than the study products during the study period;
- •Agree not to participant in other interventional studies during the study period;
- •Fully understand the property, purpose, benefits and potential risk and side effect from the study;
- •Agree to follow all study requirements and procedures;
- •Signed informed consent.
排除标准
- •Currently receiving treatment for gastrointestinal symptoms;
- •Lactose intolerance;
- •Having diseases or conditions that may affect intestinal function, such as history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, or Anorexia nervosa;
- •Currently under diet control or in use of medicine or supplements for weight control or that might affect appetite;
- •Have had laxatives or other substance that will enhance digestion within two weeks before the study begins;
- •Have had dairy products or other food containing probiotics within 10 days before the study begins;
- •Currently having diarrhea;
- •Currently pregnant or breast-feeding, or plan to be pregnant during the study period;
- •Not be able to follow study procedures according to investigators evaluation.
结局指标
主要结局
Gastrointestinal health score
时间窗: Day 0, 28
Change of the total gastrointestinal health score at day 28 from baseline. The total score is the sum of the 4 aspects of gastrointestinal health (each with score range from 0 to 3): Weekly stool frequency (\>=6; 4-6; 1-3; 0); Ratio of the number of unopened defecation to the total number of defecation (1; 1/4; 1/3; \>=1/2); Duration of defecation (\<5 minutes; 5-15 minutes; 16-30 minutes; \>=30 minutes); Defecation condition (normal perception; straining/uncomfortableness at stool; obvious straining/uncomfortableness or difficulty at defecation with little feces amount; frequent abdominal or anus pain that affect defecation).
次要结局
- Defecation satisfaction score(Day 0, 3, 7, 14, 21, 28)
- Symptom score of digestive system(Day 0, 3, 7, 14, 21, 28)
- Bristol score of stool color(Day 0, 3, 7, 14, 21, 28)
- Fecal bacterium(Day 0, 14)
- Fecal short chain fatty acids(Day 0, 14)
- Bristol score of stool characteristics(Day 0, 3, 7, 14, 21, 28)
- Fecal secretory immunoglobulin A (sIgA)(Day 0, 14)