Effect of Yogurt Containing Polydextrose, Lactobacillus Acidophilus NCFM and Bifidobacterium Lactis HN019: a Randomized, Double-blind, Controlled Study in Chronic Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Colonic transit
研究概览
简要总结
Background and aims:Constipation is a frequent complaint and the combination of a prebiotic and probiotics would have a potentially synergic effect on the intestinal transit. The present study therefore aims to investigate the combination of polydextrose (Litesse®), L. acidophilus NCFM® and B. lactis HN019 in a yogurt on intestinal transit in subjects who suffer from constipation.
Methods: Patients with constipation were randomly divided into two groups, Placebo Group (PG) and Treatment Group (TG), and had to eat 180 ml of unflavored yogurt every morning for 14 days. Those in the CG received only yogurt, while the TG received yogurt containing polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513). Expect that patients who took a combination of polydextrose has a decrease in the colonic transit time (CTT) when comparing initial and final transit time.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with chonic constipation
- •agachan between 10 and 20
- •bowel transit time with ingestion of 24 radiopaque markers (Sitzmarks) and retention of 80% of them on day 5
排除标准
- •Patients with hypothyroidism
- •antidepressant users
- •normal colonic
- •transit time (24 hrs or less) as well as higher than 96 hours were
结局指标
主要结局
Colonic transit
时间窗: Colonic transit time and Agachan score will be evaluated before and in day15 aftler yogurt ingestion. All particIpants will be followed for 30 days after the end of study
次要结局
未报告次要终点
研究者
Claudio Saddy Rodrigues Coy
PhD
University of Campinas, Brazil