NCT06863415尚未招募不适用
A Study on the Safety and Effectiveness of Bifidobacterium Longum Subsp. infantisBI45 in Improving Intestinal and Immune Functions
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in the concentration of antimicrobial peptides (LL-37 and calprotectin) in feces before and after intervention
研究概览
简要总结
Evaluate the effectiveness and safety of Bifidobacterium longum subsp. infantis BI45 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
- Prevention
- 盲法
- Single (Participant)
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 undergo 3 follow-up visits during the intervention period Be willing to provide blood, urine and stool samples 2 times during the intervention period
- •Willing to self-administer probiotic or placebo once a day during the intervention period
- •Good eyesight, can read and write, can wear glasses
- •Have good hearing and be able to hear and understand all instructions during the intervention
排除标准
- •Digestive diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease)
- •Have a serious neurological condition (epilepsy, stroke, severe head trauma, meningitis in the last 10 years, brain surgery, brain tumor, prolonged coma - not including general anaesthesia)
- •Have received/are receiving treatment for the following mental disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
- •Take medication for depression or low mood Internal organ failure (heart, liver or kidney failure, etc.)
- •Have received radiation or chemotherapy in the past
- •Have undergone a general anesthesia procedure/procedure within the past three years, or plan to undergo a general anesthesia procedure/procedure within the next 3 months during this trial period
- •Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past
研究组 & 干预措施
Probiotic Group
Experimental
Intervention with Bifidobacterium longum subsp. infantis BI45 (30 billion CFU/ day, 3g) was administered daily for 8 weeks. Store in a cool, dry place.
干预措施: Probiotic (Dietary Supplement)
Placebo Group
Placebo Comparator
Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in the concentration of antimicrobial peptides (LL-37 and calprotectin) 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
未报告次要终点
研究者
研究点 (1)
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