KCT0005826
尚未招募
未知
Clinical study to evaluate the effect of external factor on the composition of intestinal microbiota after oral administration of microbiome in healthy subject
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Jeonbuk National University Hospital
- 入组人数
- 30
- 状态
- 尚未招募
- 最后更新
- 5年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\[Group of Obesity]
- •(1\)A healthy adult who is 19 \~50 years old at the screening test
- •(2\)Body mass index (BMI) greater than 25\.0 kg / m^2
- •? Body Mass Index (BMI) \= body weight (kg) / height (m)^2
- •(3\)A person who have no congenital or chronic disease within the last 3 years and have no pathological symptoms or findings as a result of medical examination
- •(4\) A person who has bowel movements of Bristol Stool form scale Type 3\-5 more than 3 times a week
- •(5\) A person who has been judged to be suitable for the test subject to be tested at screening such as laboratory tests (hematology test, blood chemistry test, urine test, etc.) and electrocardiogram test conducted according to the characteristics of medicines
- •(6\) A person who signed the written consent to participate in this study with full understanding of the purpose and contents of the examination prior to taking the test
- •(7\) A person who has the ability and willingness to participate in the study
- •\[Group of elderly]
排除标准
- •(1\) A person with evidence or evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological or allergic disease (except for asymptomatic seasonal allergies at the time of administration)
- •(2\) A person with a history of gastrointestinal disorders (esophageal ataxia or esophageal strictures, Crohn's disease) or surgery (except for simple cecal surgery or hernia surgery) that can affect the absorption of drugs
- •(3\) Patients with a history of hypersensitivity to the drug and additives of probiotics or lactic acid bacteria preparetations or other drug(aspirin, antibiotics, etc) and food containing components
- •(4\) Screening If you have a regular alcohol intake history of more than 210 g/week within 6 months (10 g of beer (5%) \= 10 g, 1 glass of soju (20%) \= 8 g , Wine (12%), 1 cup (125 mL) \= 12 g)
- •(5\) Smokers within 3 months of screening
- •(6\) Anyone with a history of major alcohol or drug abuse within a year of screening
- •(7\) A person who is at risk of serious adverse/chronic medical, mental, or laboratory examinations that may increase the risk due to the administration of medicines for clinical trials and participation in testing, or may interfere with the interpretation of test results
- •(8\) A person who is being treated with steroid drugs
- •(9\) A person who took antibiotics within 3 months of the first administration of investigational product
- •(10\) A person who took a proton pump inhibitor (PPI) within 1 month prior to the first administration of investigational product
结局指标
主要结局
未指定
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