Assessment of Safety and Efficacy of Non-alcoholic Pasteurized Beverage Based on Kombucha, Enriched With Inulin and Vitamins in Patients With Constipations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change of number bowel movements
研究概览
简要总结
Single centre, open-label, non-randomized study is planned to proof the concept of safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with constipations
详细描述
This single-center open-label non-randomized study is planned to proof the concept on safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with irritable bowel syndrome with constipations.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •willingness to participate (based on signed informed consent form)
- •irritable bowel syndrome with predominant constipation, per Rome IV criteria (Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria: related to defecation; associated with a change in frequency of stool; associated with a change in form (appearance) of stool - Bristol stool scale types 1 or
- •Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis),
排除标准
- •pregnant or breast-feeding women;
- •intolerance of kombucha or any component of the product;
- •history of abdominal surgery;
- •the use of concomitant medications able to affect bowel motility;
- •general condition of a patient making the appropriateness of his participation in the study questionable;
- •chronic decompensated disorders of any organs and systems;
- •mean daily caloric intake less than 800 kcal and more than 6000 kcal
- •inability to follow standard iso-caloric diet and standard volume of water consumption (1.5-2 litres a day)
结局指标
主要结局
Change of number bowel movements
时间窗: two weeks
Number of bowel movements per week will be assessed per patients self report
Change of stool type
时间窗: a week
Stool type assessed per the Bristol stool scale (from type 1 to type 7; where type 1 - separate hard lumps, like nuts, type 7 - watery, no solid pieces, entirely liquid stool - diarrhoea)
次要结局
- Adverse events(two weeks)
研究者
Vasily Isakov
Professor, MD, PhD, AGAF
Russian Academy of Medical Sciences