JPRN-UMIN000049771已完成Unknown
A study to confirm the safety of overdose of bifidobacteria : a placebo-controlled, randomized, double-blind study. - A study to confirm the safety of overdose of bifidobacteria.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
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
- •1. Subjects who regularly take oral medicine (especially laxatives, antiflatulents, laxatives, etc. that affect bowel movements). 2. Subjects who have a history of Serious diseases such as diabetes, kidney/liver disease or heart disease, and/or thyroid diseases, adrenal diseases, and other metabolic diseases or who is under medical treatment. 3. Subjects who have chronic disease and is under medication. 4. Subjects with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation (Excluding appendicitis). 5. Subjects who are suffering from other serious diseases. 6. Subjects who are not able to stop ingesting foods containing live bacteria such as lactic acid bacteria, bifidobacteria, and bacillus subtilis natto, foods fortified with oligosaccharides and dietary fiber, health foods that are said to be good for improving constipation, foods containing large amounts of sugar alcohol, during the study period. 7. Subjects who are consuming large amounts of alcohol (abouts 40 g or more in terms of pure alcohol) on a daily basis. 8. Subjects who have a history of drug dependence or alcohol dependence or have a current medical history. 9. Subjects who have food and medicine allergy. 10. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. 11. Subjects who participate in other clinical trials, who have participated in other tests within one month of obtaining consent, or who are willing to participate. 12. Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
研究者
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