NCT05403398已完成不适用
Change in Markers of Immune Function Associated With Bacillus Subtilis CU1 Intervention in Different Age Groups
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
- 89
- 试验地点
- 1
- 主要终点
- Fecal sIgA
研究概览
简要总结
The current study aims to explore a range of possible pathways by which BSCU1 could beneficially modulate the immune system, in three target populations representing the general population.
详细描述
This exploratory study is designed as a single-arm study with repeated measures, involving three different populations, in which each subject serves as its own control. The duration of the intervention is 4 weeks, with biomarker assessments at baseline, after 2 weeks, and after 4 weeks intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •30 ≤ age ≤ 49 years
- •BMI ≥ 18.5 and ≤ 25 kg/m2
- •In good health as assessed during screening (by questionnaire), and the medical investigator's professional judgment
- •Non-smoking
- •65 ≤ age ≤ 79 years
- •BMI ≥ 22.0 and ≤ 28.0 kg/m2
- •Generally healthy as assessed during screening (by questionnaire), and the medical investigator's professional judgment
- •Non-smoking
- •3 ≤ age ≤ 6 years
- •Healthy BMI, cut-off points will be used as indicated by JGZ
- •Generally healthy as assessed during screening (by parental anamnesis), and the study physician's professional judgment
排除标准
- •Adults and elderly
- •Chronic illness (e.g., diabetes mellitus, cardiac insufficiency, respiratory insufficiency, cancer, chronic kidney or liver disease),
- •Acute infection in the past month
- •Gastrointestinal disorders (e.g., inflammatory bowel disease),
- •Acute gastroenteritis in the past 2 months
- •Any vaccination in the past month or any scheduled vaccination during the study period
- •Treatment with antibiotics within 2 months before the start of the study and during the study period
- •Regular use of laxative agents
- •Immunodeficiency disorder
- •Use of anti-inflammatory or immunosuppressive drugs (e.g.cyclosporine, azathioprine, systemic corticosteroids, antibodies)
- •Unexplained weight loss or weight gain of > 3 kg in the 3 months prior to pre-study screening
- •Regular consumption of probiotics within 1 month before start of the study
- •Evidence of current excessive alcohol consumption (>4 consumptions/day or >20 consumptions/week) or drug (ab)use
- •Mental status that is incompatible with the proper conduct of the study
- •Acute respiratory or gastrointestinal infection in the past month
- •Chronic illness (e.g. chronic infections, systemic or metabolic disease)
- •Gastrointestinal disorders (e.g., inflammatory bowel disease),
- •Acute gastroenteritis in the past 2 months
- •Any vaccination in the past month or any scheduled vaccination during the study period
- •Treatment with antibiotics within 2 months before the start of the study and during the study period
- •Immunodeficiency disorder
- •Use of anti-inflammatory or immunosuppressive drugs (e.g.cyclosporine, azathioprine, systemic corticosteroids, antibodies)
- •Regular use of laxative agents
- •Regular consumption of probiotics within 1 month before start of the study
研究组 & 干预措施
BSCU1
Experimental
B. subtilis CU1 at 2 billion CFUs daily for 4 weeks
干预措施: B. subtilis CU1 (Dietary Supplement)
结局指标
主要结局
Fecal sIgA
时间窗: 4 weeks
Change in fecal sIgA concentration
次要结局
- Ex-vivo cytokines concentration(4 weeks)
- Immune cell phenotyping(4 weeks)
- Ex-vivo phagocytosis(4 weeks)
- RNA sequencing(4 weeks)
- Serum cytokine concentration(4 weeks)
- Fecal microbiota(4 weeks)
研究者
研究点 (1)
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