KCT0007564已完成未知
Human study to evaluate the effectiveness and safety of 'Lactomin Plus' on the improvement of bowel function
Ajou University Hospital0 个研究点目标入组 39 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 39
研究概览
简要总结
When adult men and women complaining of intestinal discomfort due to diarrhea consumed 12 g of lactomin plus per day for 8 weeks, the frequency of bowel movements and satisfaction with normal bowel movements were significantly increased from the 4th week compared to the control group. In the case of the intestinal flora, it was confirmed that Lactobacillales at the class level, Bacilli at the class level, and Streptococaceae at the family level increased compared to before intake, and these strains are considered to have contributed to the improvement of the intestine. In terms of safety, it was found to be safe as a result of evaluating vital signs, clinical blood and urine tests, and adverse events.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1) Subjects who voluntarily agree to participate and sign informed consent forms
- •2) Adults (20 = age < 65 years)
- •3) Subjects who have bad bowel movement
- •4) Subjects who have positive fecal calprotectin level
排除标准
- •1) Subject who consumes probiotics, prebiotics or antibiotics over 1 week consistently within 1 month
- •2) Subject who consumes high dietary fiber
- •3) Subject who has other underlying disease in digestive system currently or within two years
- •4) Subject who has intestinal surgery
- •5) Subject who has lactose intolerance
- •6) Subject who has diseases described below or takes related drugs:
- •- severe liver disease, renal dysfunction, cardiovascular disease, immunological diseases and malignant tumors, etc
- •7) Subject who took the antiepileptic or antidiarrheal drugs within three days of his first visit
- •8) In the case of trip to area with epidemic parasitic diseases recently
- •9) Subject who has hypersensitivity to test food or ingredients of test food
- •10) Subject who has been in clinical trial within 1 month
- •11) Pregnant or lactating women or person who has pregnancy plan during the study
- •12) Any condition that the principal investigator believes may put the subjects at undue risk
研究者
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