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

Not Applicable

Completed

• Conditions: IBD - Inflammatory Bowel Disease
• Interventions: Drug: BXD treatment

• Registration Number: NCT07035613
• Lead Sponsor: China Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-27
• Status Verified: 2025-06
• Primary Completion: 2025-06-06
• Study Completion: 2025-06-06
• Study First Submitted: 2025-06-08
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BXD treatment (single group)	BXD treatment	Participants will receive BXD daily for 14 days. Plasma IgA and fecal 16S-FL sequence will be measured at baseline and after treatment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

China medicial university hospital; 🇨🇳 Taichung, Taiwan