NCT06886711尚未招募不适用
A Study on the Safety and Efectiveness of Bifidobacterium Bifidum BBi32 in Improving Lntestinal and Lmmune Functions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Fecal Microbiota Composition Before and After Intervention
研究概览
简要总结
Evaluate the efectiveness and safety of Bifidobacterium bifidum BBi32 as a food supplement compared to a placebo in improving intestinal andimmune functions 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
结局指标
主要结局
Change in Fecal Microbiota Composition Before and After Intervention
时间窗: Baseline (Week 0) and post-intervention (Week 8)
Fecal microbiota composition will be analyzed using 16S rRNA gene sequencing to assess taxonomic and relative abundance changes.
次要结局
未报告次要终点
研究者
研究点 (1)
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