NCT07378280已完成不适用
A Randomized, Double-blinded, Placebo-controlled, Multi-center Study to Investigate the Effect of L. Lactis CKDB001 Administration on Liver Aminotransferases in Subjects With Nonalcoholic Fatty Liver Disease
Chuncheon Sacred Heart Hospital1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2021年8月18日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Changes in liver function parameters: AST (U/L), ALT (U/L)
研究概览
简要总结
A study for evaluating the safety and efficacy of L. lactis CKDB001 on liver aminotransferases in subjects with nonalcoholic fatty liver disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women aged 19 to 75 years at the time of written consent
- •Voluntarily provided written consent after receiving sufficient explanation about the study
- •ALT or AST levels exceed the upper limit of normal, but are five times or less than the upper limit
排除标准
- •Pregnant or breastfeeding women
- •Women of childbearing potential and men who are unable or unwilling to use appropriate contraception during the study period
- •Individuals with a history of alcohol abuse or chronic alcohol consumption:
- •Daily alcohol consumption averaging over 30g/day (210g/week) for men or over 20g/day (140g/week) for women
- •Individuals with viral or other liver diseases that could affect study results:
- •Individuals with a history of or current drug abuse
- •Individuals with a history of psychiatric disorders or current psychiatric conditions that may interfere with the study
- •Individuals with a history of major gastrointestinal surgery (excluding appendectomy, but including gastric resection, gastrointestinal bypass, anastomosis, bariatric metabolic surgeries)
- •Individuals with severe comorbidities that make them unsuitable for study participation (e.g., heart disease, kidney disease, malignancy, immunosuppression, etc.):
- •Regular consumption of probiotics, prebiotics, synbiotics, or fermented milk within 4 weeks prior to screening (participation allowed if consumption ceases at least 1 month before study start)
- •Regular consumption of medications, health supplements, or herbal remedies that may affect liver function or anti-inflammatory responses within 4 weeks prior to screening (participation allowed if consumption ceases at least 1 month before study start)
- •Use of medications that may cause hepatic steatosis (e.g., amiodarone, tamoxifen, methotrexate, tetracycline, corticosteroids)
- •Use of medications for treating non-alcoholic fatty liver disease (NAFLD) or steatohepatitis (NASH) within 3 months prior to screening (e.g., thiazolidinediones, vitamin E)
- •Use of medications that may affect study results (e.g., antipyretic analgesics, NSAIDs, anti-tuberculosis drugs, antibiotics, anticonvulsants, choleretics, liver disease medications)
- •Use of oral steroids, hormones, or drugs that may affect absorption, metabolism, or excretion of food within 4 weeks prior to screening (participation allowed if taking systemic steroids or thyroid hormones in stable doses for ≥3 months before screening)
- •Use of hypoglycemic agents or lipid-lowering drugs (except insulin or thiazolidinediones) with stable doses for at least 3 months prior to screening
- •Dietary or exercise therapies that may affect study within 3 months prior to screening
- •Smokers consuming more than 20 cigarettes per day
- •Allergies or digestive issues related to study food ingredients
- •Weight loss exceeding 10% of previous body weight within 6 months prior to screening
- •Participation in another clinical trial within 30 days prior to screening or not completing the required five-half-life period of investigational drug/food from a previous trial
- •Any other individuals deemed unsuitable for the study by the investigator
研究组 & 干预措施
Placebo
Placebo Comparator
The selected test subjects were randomly assigned to placebo and L. lactis CKDB001 group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and treated with placebo for 12 weeks. After treatment, primary and secondary outcomes were analyzed.
干预措施: Placebo (Dietary Supplement)
L. lactis CKDB001
Experimental
The selected test subjects were randomly assigned to placebo and L. lactis CKDB001 group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and treated with L. lactis CKDB001 (5.0E+09 CFU/day) for 12 weeks. After treatment, primary and secondary outcomes were analyzed.
干预措施: Probiotics (L. lactis CKDB001) (Dietary Supplement)
结局指标
主要结局
Changes in liver function parameters: AST (U/L), ALT (U/L)
时间窗: From baseline to 12 weeks
Change from baseline to 12 weeks in the specified liver function parameters will be assessed.
次要结局
- Changes in liver function parameters: γ-GTP (U/L), ALP (U/L)(From baseline to 12 weeks)
- Changes in bilirubin parameters: Total bilirubin (mg/dL), Direct bilirubin (mg/dL)(From baseline to 12 weeks)
- Changes in protein parameters: Total protein (g/dL), Albumin (g/dL), Globulin (g/dL)(From baseline to 12 weeks)
- Changes in lipid parameters: Total cholesterol (mg/dL), LDL-C (mg/dL), HDL-C (mg/dL), Triglycerides (mg/dL)(From baseline to 12 weeks)
- Changes in fasting plasma glucose levels (mg/dL)(From baseline to 12 weeks)
- Changes in fasting serum insulin levels (μU/mL)(From baseline to 12 weeks)
- Changes in insulin resistance index: HOMA-IR(From baseline to 12 weeks)
- Changes in inflammatory markers: TNF-α (pg/mL), IL-6 (pg/mL), IL-10 (pg/mL)(From baseline to 12 weeks)
- Changes in high-sensitivity C-reactive protein levels (mg/L)(From baseline to 12 weeks)
- Changes in Fatigue Severity Scale (FSS)(From baseline to 12 weeks)
- Changes in gut environment assessed by metagenomics and metabolomics(From baseline to 12 weeks)
- Changes in body weight (kg)(From baseline to 12 weeks)
- Changes in body mass index (kg/m²)(From baseline to 12 weeks)
- Changes in waist circumference (cm)(From baseline to 12 weeks)
- Changes in hip circumference (cm)(From baseline to 12 weeks)
- Changes in waist-to-hip ratio (WHR)(From baseline to 12 weeks)
研究者
研究点 (1)
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