IBD - Inflammatory Bowel Disease
Conditions
Brief summary
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.
Interventions
DRUGBXD treatment
The BXD extract was obtained from Sun Ten Pharmaceutical Company and is manufactured according to the standard procedures outlined in the Taiwan Herbal Pharmacopeia IV. The extract is produced using a fixed herbal composition and ratio based on the traditional BXD formula to yield a concentrated powder. The administration of BXD in this study follows the dosage and usage guidelines specified in the Pharmacopeia.
Sponsors
China Medical University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female participants aged ≧20 years. 2. Participants who are able to provide signed informed consent. 3. Healthy individuals with no history of major illnesses or cancer.
Exclusion criteria
1. Inclusion who do not meet the inclusion criteria. 2. Individuals deemed unsuitable for participation by the investigator. 3. The individual is unable to comply with the study schedule. 4. Individuals unable to provide signed informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changed in plasm IgA levels from baseline to Day14 measured by ELISA | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Fecal samples were collected at baseline (Day 0) and on Day 14. Microbiota composition was analyzed using full-length 16S rRNA sequencing. The outcome will summarize the relative abundance of key bacteria taxa and diversity indices before and after BXD treatment. Time： From enrollment to Day 14. |
Countries
Taiwan
Outcome results
None listed