Investigating Chinese Herbal Medicine for Modulating Gut Microbiota in Treating Inflammatory Bowel Disease: Molecular Mechanisms and Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changed in plasm IgA levels from baseline to Day14 measured by ELISA
研究概览
简要总结
The goal of this exploratory, single-arm intervention study is to evaluate whether Banxia Xiexin Decoction (BXD) can prevent colitis by modulating gut microbiota composition and regulating immune responses, including IgA production, in healthy adults.
The main questions it aims to answer are:
Can BXD prevent colitis by modulating gut microbiota composition? Can BXD enhance immune markers such as IgA without adverse effects?
There is no comparison group in this study.
Participants will:
Take BXD daily for 14 days. Provide stool and blood samples for microbiota analysis and immune marker testing.
Eligible participants include healthy men and women aged 20 years or older, with no major illnesses, autoimmune diseases, cancer, or recent use of antibiotics, immunosuppressants, or probiotics.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants aged ≧20 years.
- •Participants who are able to provide signed informed consent.
- •Healthy individuals with no history of major illnesses or cancer.
排除标准
- •Inclusion who do not meet the inclusion criteria.
- •Individuals deemed unsuitable for participation by the investigator.
- •The individual is unable to comply with the study schedule.
- •Individuals unable to provide signed informed consent.
研究组 & 干预措施
BXD treatment (single group)
Participants will receive BXD daily for 14 days. Plasma IgA and fecal 16S-FL sequence will be measured at baseline and after treatment.
干预措施: BXD treatment (Drug)
结局指标
主要结局
Changed in plasm IgA levels from baseline to Day14 measured by ELISA
时间窗: From enrollment to the end for 2 time points (Day 0 and Day 14) to collect the plasma sample.
Plasma IgA concentration will be measured at baseline (Day 0) and Day 14 using a validated ELISA method. The primary outcome will be the mean change in plasma IgA levels from baseline to Day 14. Time : From enrollment to Day 14
次要结局
- Change in gut microbiota composition from baseline to Day 14 assessed by 16S rRNA full-length sequencing(Fecal samples were collected before(Day 0) and after the treatment(Day 14) period.)