"Study of Immunological Biomarkers in Response to Probiotic Intake"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Fecal flora cultures (Count of colonies/mL)
研究概览
简要总结
The study included 21 adult participants, aged 19-46 years (19 female participants and 2 male participants). The selection criteria included the following parameters: Body Mass Index (BMI), calculated as weight (kg) divided by height squared (m²), between 18.5 and 29.99; Waist-to-Hip Ratio with thresholds set at >0.90 for males and >0.85 for females for individuals with normal weight (eutrophic); percentage of body fat: Considered within normal range if <30% for individuals with normal weight. Standard biochemical and anthropometric measurements were carried out to all the subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 46 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 18.5 and 29.99;
- •Waist-to-Hip Ratio with thresholds set at >0.90 for males and >0.85 for females for individuals with normal weight (eutrophic)
- •Percentage of body fat: Considered within normal range if <30% for individuals with normal weight.
排除标准
- 未提供
研究组 & 干预措施
Intervention group
Healthy subjects
干预措施: Lactobacillus casei DN-114001 (Dietary Supplement)
结局指标
主要结局
Fecal flora cultures (Count of colonies/mL)
时间窗: From enrollment to the end of treatment at 45 days weeks, every 15 days
Relative amount of colonies (CFU) of Escherichia coli, Clostridium species and Lactobacillus
Serum immunoglobulins
时间窗: From enrollment to the end of treatment at 45 days weeks, every 15 days
Serum concentration of G, A, M, and G subclasses, as well as the complement C3 and C4 factors,
Lymphocyte Subpopulations
时间窗: From enrollment to the end of treatment at 45 days weeks, every 15 days
Concentration of T Lymphocytes: CD3, CD4, CD8, CD45 RA, and CD45 RO (distinguishing between helper T cells, cytotoxic T cells, and naïve or memory subsets within each group). ii) B Lymphocytes: CD19; iii) NK Cells: CD16 and CD56.
次要结局
未报告次要终点
研究者
Alfredo Corell
Prof. Dr.
University of Valladolid