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

NCT ID: NCT07035613

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-27

Study Completion Date

2025-06-06

Brief Summary

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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

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Conditions

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IBD - Inflammatory Bowel Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

BXD treatment

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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China medicial university hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMUH113-REC2-034

Identifier Type: -

Identifier Source: org_study_id

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