JPRN-UMIN000043006已完成未知
A Study on the Effect of Plant-Derived Products on gut microbiome -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- - A Study on the Effect of Plant-Derived Products on gut microbiome
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
Statistically significant difference was confirmed in the primary outcome.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Subjects (who) (1)regularly use intestinal and constipation drugs (including laxatives). (2)can't stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relieve constipation (including Food for Specified Health Uses or Foods with Function Claims) and/or containing a large amount of sugar alcohol during this study. (3)regularly eat foods containing lactic acid bacteria, bifidobacteria, and/or oligosaccharides to relieve constipation. (4)used antibiotics within the last 2 weeks prior to the screening. (5)have a history and/or a surgical history of digestive disease affecting digestion and absorption. (6)have been diagnosed irritable bowel syndrome or inflammatory bowel disease. (7)have any food allergies. (8)have excessive alcohol intake more than approximately 20 g / day of pure alcohol equivalent or habit of drinking more than 4 days a week. (9)can't stop drinking from 2 days before each measurement. (10)are shiftworker and/or midnight-shift worker. (11)contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease). (12)with greatly disturbed menstrual cycle. (13)plan to become pregnant after informed consent, pregnant or lactating. (14)have donated over 200 mL of blood and/or blood components within the last 1 month or over 400 mL of blood and/or blood components within the last 3 months prior to the study. (15)are under treatment for or have a history of drug addiction and/or alcoholism. (16)plan to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month. (17)are judged unsuitable for the study by the screening. (18)are judged unsuitable for the study by the investigator for other reasons.
研究者
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