The Effects of ABKefir on Functional Constipation in Subjects: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Change from baseline symptoms of constipation at week 4 and 8
研究概览
简要总结
The purpose of this study was to evaluate the efficacy of 1 capsules of ABKefir per day on symptoms of constipation in subjects with functional constipation by clinical trial.
详细描述
This randomized, placebo-controlled clinical trial will be conduct for 8 weeks with one hundred and sixty-five adults. Subjects will be recruited and randomly assigned into three groups: (1) placebo, n = 55; (2) low dose of ABKefir , n = 55; (3) high dose of ABKefir, n = 55. During the first 4 weeks of supplement, the subjects should take one capsule of placebo or ABKefir daily. Apart from containing no probiotics, the content of placebo is same as ABKefir. After that, the next 4 weeks is to have a follow-up of subjects. During this phase, subjects don't need to supplement. Subjects should complete the assessment of anthropometric measurement, defecation questionnaire , food record, feces and blood collection at week 0, 4 and week 8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female
- •aged 18-75 years old
- •fulfill Rome IV criteria for functional constipation
- •have not participated in similar research in the past three months
排除标准
- •Personal or family history of colon cancer, celiac disease, and inflammatory bowel disease
- •Irritable bowel syndrome diagnosed during colonoscopy
- •Those who are pregnant recently (including men and women), or are pregnant or breastfeeding women.
- •Taking antidepressants, anti-anxiety drugs and other psychotropic drugs.
- •Long-term medication is required to improve constipation
- •Those diagnosed with myocardial infarction, cerebral infarction, malignant tumor and/or other serious diseases are not suitable for participating in the study.
- •Allergic symptoms to probiotics or any ingredients
- •Having a history of serious mental illness
- •Drug-related crimes or alcohol problems
- •Have recently traveled to areas where parasitic diseases are prevalent.
研究组 & 干预措施
Placebo
The composition of placebo capsules is same as the experimental capsules, except that they don't contain probiotics.
干预措施: Placebo (Dietary Supplement)
Low dose of ABKefir
Low dose of probiotics, 5×10^9 CFU/capsule
干预措施: Probiotics (ABKefir) (Dietary Supplement)
High dose of ABKefir
High dose of probiotics, 1×10^10 CFU/capsule
干预措施: Probiotics (ABKefir) (Dietary Supplement)
结局指标
主要结局
Change from baseline symptoms of constipation at week 4 and 8
时间窗: Week 0, 4 and 8
Compared the difference of bowel movements between the week 0, 4 and 8.
次要结局
未报告次要终点