IBD - Inflammatory Bowel DiseaseNCT07035613
Investigating Chinese Herbal Medicine for Modulating Gut Microbiota in Treating Inflammatory Bowel Disease: Molecular Mechanisms and Clinical Study
A study testing BXD treatment in people with IBD - Inflammatory Bowel Disease, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- IBD - Inflammatory Bowel Disease
- What is being tested?
- BXD treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Feb 2024to 6 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inclusion who do not meet the inclusion criteria.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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
- Being tested
- BXD treatment
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BXD treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BXD treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 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.
Measured: Fecal samples were collected before(Day 0) and after the treatment(Day 14) period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start27 Feb 2024
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD - Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035613
- Sponsor's protocol ID
- CMUH113-REC2-034
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Chinese Herbal Medicine for Modulating Gut Microbiota in Treating Inflammatory Bowel Disease: Molecular Mechanisms and Clinical Study
- ClinicalTrials.gov ID
- NCT07035613
- Acronym / sponsor ID
- CMUH113-REC2-034
- Conditions
- IBD - Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BXD treatment (single group) | Experimental | Drug: BXD treatmentParticipants will receive BXD daily for 14 days. Plasma IgA and fecal 16S-FL sequence will be measured at baseline and after treatment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Inclusion who do not meet the inclusion criteria.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BXD treatmentThe 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. | Drug | BXD treatment (single group) |
Primary outcome
Changed in plasm IgA levels from baseline to Day14 measured by ELISA
Time frame: 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
1 secondary outcome
Change in gut microbiota composition from baseline to Day 14 assessed by 16S rRNA full-length sequencing
Time frame: Fecal samples were collected before(Day 0) and after the treatment(Day 14) period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BXD treatment in people with IBD - Inflammatory Bowel Disease, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changed in plasm IgA levels from baseline to Day14 measured by ELISA (time frame: From enrollment to the end for 2 time points (Day 0 and Day 14) to collect the plasma sample.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.