Investigating Chinese Herbal Medicine for Modulating Gut Microbiota in Treating Inflammatory Bowel Disease: Molecular Mechanisms and Clinical Study

China Medical University

Status: Completed

Conditions: IBD - Inflammatory Bowel Disease

Treatments: Drug: BXD treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07035613

CMUH113-REC2-034

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

BXD treatment (single group)

Experimental group

Description:

Participants will receive BXD daily for 14 days. Plasma IgA and fecal 16S-FL sequence will be measured at baseline and after treatment.

Treatment:

Drug: BXD treatment