KCT0008108已完成未知
A 12 week, randomized, double blind, placebo-controlled exploratory clinical trial for the evaluation of the efficacy and safety of Streptococcus thermophilus LM1012 on improving liver function
actomason0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 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 Study
入排标准
- 年龄范围
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1) 19 ~ 70 years of age
- •2) ALT level 35~105 IU/L
- •3) Subjects who agree to participated in the study and sign the informed consent form
排除标准
- •1) AST or GGT > 3-fold of normal range
- •2) Subjects who usually drink alcohol as follows within 3 months
- •- Male > 210 g/weeks
- •- Female > 140 g/weeks
- •3) Patients with acute or chronic hepatitis or carriers of viral hepatitis (type B or C)
- •4) History of underlying cirrhosis and liver cancer
- •5) History of underlying biliary diseases such as jaundice or gallstones (But, asymptomatic gallstones etc. can be enrolled under the judgment of the researcher)
- •6) Patients who have clinically significant acute or chronic cardio-cerebrovascular systems, hepatic, musculoskeletal, neurologic, psychiatric, endocrine systems, immune, renal, malignant tumor and pulmonary disease etc.
- •7) Administration of antibiotic within 2 weeks before screening visit
- •8) Intake of probiotics or fermented milk products (yogurt, cheese, etc.) within 2 weeks before screening visit(more than 4 times/week)
- •9) Administration of drugs that affect liver function (antiviral drugs, antituberculosis drugs, antiseizure drugs, arthrifuge, antidepressant, lipid-lowering agents, anesthetic agents, hepatoprotective agents etc.), adrenal cortex hormones or sex hormone within 4 weeks before screening visit
- •10) Taking the liver function improving supplements (Milk thistle etc.), oriental medicine, OTC(Over The Counter) within 2 weeks before the screening visit
- •11) Allergic or hypersensitivity to drug and any of the ingredients in the test products (probiotics, crystalline cellulose etc.)
- •12) Subjects who have past history or currently in the treatment of significant clinical disease related to liver biliary system, kidney, nervous system(central or peripheral), respiratory system(asthma etc.), endocrine system(uncontrolled hyperlipidemia, thyroid disorder etc.), cardiovascular system(congestive heart failure, coronary artery disease, myocardial infarction etc.), blood neoplastic, urinary system, psychiatric, musculoskeletal system, immune system(rheumatoid arthritis, systemic lupus erythematosus, immunodeficiency diseases)
- •13)History of substance abuse
- •14) History of disease that could interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery
- •15) Those who have participated in other studies within 3 months before screening
- •16) Pregnant, planning to become pregnant, or breast-feeding
- •17) Female subjects of childbearing potential who are not willing to use appropriate contraception (except for surgery for female infertility)
- •18) Laboratory test by show the following results
- •? Serum creatinine > 2.0 mg/dL
- •19) A person who is determined by the test manager to be unsuitable for participation in the study due to other reasons, including the results of diagnostic tests.
研究者
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