NCT06875362已完成不适用
Safety and Efficacy of LR08 in Modulating Gut Microbiota and Improving Metabolic Health in Healthy Adults: A Clinical Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Changes in Immune Function
研究概览
简要总结
Evaluate the efficacy and safety of LR08 as a dietary supplement compared to a placebo in enhancing intestinal health and immune function in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to attend 3 follow-up visits during the intervention period
- •Agree to provide blood, urine, and stool samples twice during the intervention period
- •Good eyesight, able to read and write, and capable of wearing glasses if needed
- •Good hearing and able to fully comprehend all instructions during the intervention
排除标准
- •Presence of digestive diseases, particularly gastrointestinal disorders (e.g., celiac disease, ulcerative colitis, Crohn's disease)
- •History of serious neurological conditions (e.g., epilepsy, stroke, severe head trauma, meningitis within the last 10 years, brain surgery, brain tumor, or prolonged coma-not including general anesthesia)
- •History of or currently receiving treatment for mental health disorders such as alcohol/drug/substance abuse, schizophrenia, psychosis, or bipolar disorder
- •Currently taking medication for depression or low mood
- •Presence of internal organ failure (e.g., heart, liver, or kidney failure)
- •History of radiation therapy or chemotherapy treatments
- •Underwent general anesthesia within the past three years or are scheduled for general anesthesia within the next 3 months during the trial period
- •History of hepatitis (B or C), HIV, or syphilis
研究组 & 干预措施
Placebo group
Placebo Comparator
Every day to give 3 g maltodextrin intervention for 8 weeks.
干预措施: Placebo (Dietary Supplement)
Probiotic group
Active Comparator
Intervention with probiotic LR08 (30 billion CFU/day, 3g) was administered daily for 8 weeks.
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Changes in Immune Function
时间窗: Week 0 and Week 8
Evaluation of immune function markers, specifically immunoglobulin A (IgA) concentration, to assess the effects of LR08 supplementation compared to placebo.
次要结局
未报告次要终点
研究者
研究点 (1)
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