NCT04667884已完成不适用
Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation Among Adults
Health Science Center of Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年8月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of bowel movements per week
研究概览
简要总结
This study intends to evaluate the effects of three prebiotic solid beverages (mainly dietary fiber and prebiotics) and one probiotic solid beverage on the laxative effect of patients with functional constipation through randomized controlled trials. The influence of tract flora is expected to provide a basis for related therapies for patients 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults: 18 to 70 years old (not less than 50% of the final population over 45 years old, and not less than 30% of men);
- •Patients with functional constipation (refer to Rome IV diagnostic criteria for functional constipation); * Symptoms appeared for at least 6 months before diagnosis, and met the above diagnostic criteria in the past 3 months
排除标准
- •Pregnant and lactating women;
- •Unable to take the test sample and complete the inspection items as required due to inability to take food by mouth, weakness, allergies or other reasons (including the inability to complete all items due to recent travel plans);
- •Unclear main complaint and obvious abnormal mental state;
- •The liver and kidney function indexes are obviously abnormal (combined with the results of physical examination within the past 1 year);
- •Acute gastrointestinal diseases occurred in the past month, and constipation caused by surgical operations in the past month;
- •Take antibiotics, laxatives or topical agents, anticholinergics, antidiarrheals frequently in the past 1 month, and the frequency is more than 1 time/week
- •Have been diagnosed with the following diseases: cancer (especially cancer of the digestive tract), severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness;
- •Have been diagnosed with the following diseases: severe systemic diseases such as stroke, heart disease, liver cirrhosis, renal failure, hematopoietic system, or qualitative intestinal diseases caused by colonoscopy or imaging display;
- •In the past 3 months, there are often abdominal pain, abdominal pain accompanied by changes in bowel characteristics or frequency, blood in the stool, diarrhea or involuntary weight loss;
- •Clinical manifestations or diseases that other researchers believe are not suitable for participating in the project.
结局指标
主要结局
Number of bowel movements per week
时间窗: week 0 to 4
bowel movements will be recorded per week
次要结局
- glucose(day 0, 14, 28)
- diversity and abundance of intestinal flora(day 0, 14, 28)
- HDL-C(day 0, 14, 28)
- LDL-C(day 0, 14, 28)
- Classification of bowel status(day 0, 14, 28)
- Tch(day 0, 14, 28)
- Bristol classification of stool characteristics(day 0, 14, 28)
- TG(day 0, 14, 28)
研究者
Jiaomei Yang
Assistant Professor
Health Science Center of Xi'an Jiaotong University
研究点 (1)
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