NCT06873438已完成不适用
A Study on the Safety and Effectiveness of Lactobacillus Delbrueckii Subsp. Bulgaricus LB42 in Improving Intestinal and Immune Functions
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
- 52
- 试验地点
- 1
- 主要终点
- Change in the concentration of LL-37 in feces before and after intervention.
研究概览
简要总结
Evaluate the effectiveness and safety of Lactobacillus delbrueckii subsp. bulgaricus LB42 as a food supplement compared to a placebo in improving intestinal and immune 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
- •Age 18-45 years
- •Willing to undergo 3 follow-up visits during the intervention period
- •Willing to provide 2 blood, urine, and stool samples during the intervention period
- •Willing to self-administer one of the probiotics/placebo once daily during the intervention period
- •Good eyesight, able to read and write, and can wear glasses
- •Have good hearing and be able to hear and understand all instructions during the intervention
排除标准
- •Suffering from digestive disorders, mainly gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease)
- •Has a severe neurological condition (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, prolonged coma - excluding general anesthesia)
- •Has received/is receiving treatment for the following psychiatric disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
- •Take medication for depression or low mood
- •Suffering from internal organ failure (heart, liver, or kidney failure, etc.)
- •Radiotherapy or chemotherapy in the past
- •Surgery/procedure under general anesthesia within the past three years, or planned to undergo a procedure/procedure under general anesthesia within the next 3 months during this trial
- •Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past
研究组 & 干预措施
Probiotic group
Experimental
Lactobacillus delbrueckii subsp. bulgaricus LB42 (30 billion CFU/day, 3g) was administered daily for 8 weeks. Store in a cool and dry place.
干预措施: Probiotic group (Dietary Supplement)
Placebo group
Placebo Comparator
Every day to give 3g dextrin intervention for 8 weeks. Store in a cool and dry place.
干预措施: Placebo group (Dietary Supplement)
结局指标
主要结局
Change in the concentration of LL-37 in feces before and after intervention.
时间窗: Week 0 and Week 8
Detected by Enzyme-Linked Immunosorbent Assay (ELISA).
次要结局
- Change in the composition of fecal microbiota before and after intervention.(Week 0 and Week 8)
- Change in the concentration of calprotectin in feces before and after intervention.(Week 0 and Week 8)
研究者
研究点 (1)
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