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

NCT07035613 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-25

No results posted yet for this study

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.

Conditions

  • IBD - Inflammatory Bowel Disease

Interventions

DRUG

BXD 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 & Collaborators

  • China Medical University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-27
Primary Completion
2025-06-06
Completion
2025-06-06

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07035613 on ClinicalTrials.gov