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

NCT07035613 | Completed

• 1 other identifier: CMUH113-REC2-034
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

IBD - Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Changed in plasm IgA levels from baseline to Day14 measured by ELISA

  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

  From enrollment to the end for 2 time points (Day 0 and Day 14) to collect the plasma sample.

Secondary Outcomes (1)

• 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.

Study Arms (1)

BXD treatment (single group)

EXPERIMENTAL

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

Drug: BXD treatment

Interventions

BXD treatment 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.

BXD treatment (single group)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged ≧20 years.
• Participants who are able to provide signed informed consent.
• Healthy individuals with no history of major illnesses or cancer.

You may not qualify if:

• Individuals deemed unsuitable for participation by the investigator.
• The individual is unable to comply with the study schedule.
• Individuals unable to provide signed informed consent.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China medicial university hospital

Taichung, 40447, Taiwan

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 25, 2025
• Study Start: February 27, 2024
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

TW (1)