Colorectal AdenomasNCT07519681
Effects of Berberine on the Human Gut Microbiome
A study testing Berberine Hydrochloride in people with Colorectal Adenomas and Colorectal Cancers, run by Jing-yuan Fang, MD, Ph. D.
Trial summary
Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the human gut microbiome. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Adenomas, Colorectal Cancers
- What is being tested?
- Berberine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatients undergoing colonoscopy at Renji Hospital who meet the following criteria:
- Aged 18-75 years;
- Had at least one but no more than six histologically confirmed colorectal adenomas (including tubular, tubulovillous, and villous adenomas) removed within 6 months prior to enrollment;
- Provide informed consent for this study and are able to comply with the requirements for collecting qualified stool specimens, peripheral blood specimens, and providing relevant lifestyle and medical history information.
- Healthy subjects who meet the following criteria:
- Aged 18-75 years;
- Have undergone colonoscopy within 6 months prior to enrollment with no histologically confirmed colorectal adenomas (including tubular, tubulovillous, and villous adenomas);
- Provide informed consent for this study and are able to comply with the requirements for collecting qualified stool specimens, peripheral blood specimens, and providing relevant lifestyle and medical history information.
Who cannot join
- The following outpatients undergoing colonoscopy at Renji Hospital:
- Incomplete resection of adenoma during colonoscopy;
- Individuals at high risk for hereditary colorectal cancer;
- Regular use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, calcium, or vitamin D (defined as daily intake of ≥100 mg aspirin and ≥1200 mg calcium for at least 3 months);
- History of subtotal gastrectomy, total gastrectomy, or partial enterectomy;
- History of severe cardiac, hepatic, renal disease, or cancer;
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- Severe constipation or psychiatric disorders;
- Pregnant, breastfeeding, or planning to become pregnant;
- Undergone colonoscopy with inadequate bowel preparation (rated as "poor" or "insufficient" according to the Aronchik scale) or short observation time (withdrawal time <6 minutes).
- Use of antibiotics, probiotics, or prebiotics within 1 month prior to enrollment.
- The following healthy subjects:
- Individuals at high risk for hereditary colorectal cancer;
- Regular use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, calcium, or vitamin D (defined as daily intake of ≥100 mg aspirin and ≥1200 mg calcium for at least 3 months);
- History of subtotal gastrectomy, total gastrectomy, or partial enterectomy;
- History of severe cardiac, hepatic, renal disease, or cancer;
- Severe constipation or psychiatric disorders;
- Pregnant, breastfeeding, or planning to become pregnant;
- Undergone colonoscopy with inadequate bowel preparation (rated as "poor" or "insufficient" according to the Aronchik scale) or short observation time (withdrawal time <6 minutes).
- Use of antibiotics, probiotics, or prebiotics within 1 month prior to enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Berberine on the Human Gut Microbiome: An Exploratory Study in Healthy Volunteers and Patients With Colorectal Adenomas
Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the human gut microbiome.
- Conditions
- Colorectal Adenomas, Colorectal Cancers
- Being tested
- Berberine Hydrochloride
- Keywords
- colorectal adenomas, colorectal cancers, Berberine hydrochloride, human gut microbiome
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berberine HydrochlorideDrug
Oral Administration of Berberine Hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Berberine hydrochloride administration | Experimental | Not described Receives: Drug: Berberine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative abundance of Akkermansia in fecal samples as measured by quantitative PCR (qPCR)
Fecal samples will be collected at baseline (prior to berberine hydrochloride administration) and after treatment. The relative abundance of Akkermansia will be quantified using quantitative PCR (qPCR) targeting species-specific 16S rRNA gene sequences. Results will be expressed as the relative abundance normalized to total bacterial load (ΔCt method). Changes from baseline to post-treatment will be calculated for each participant and summarized across the study population.
Measured: 2 weeks
Secondary outcomes (5)
Relative abundance and diversity of gut microbiota in fecal samples as assessed by 16S rRNA gene sequencing
Fecal samples will be collected at baseline (prior to berberine hydrochloride administration) and after treatment. Gut microbiota composition will be analyzed using 16S rRNA gene sequencing. Outcomes will include:
- relative abundance of bacterial taxa at the phylum and genus levels (excluding Akkermansia where applicable), and
- alpha diversity indices (Shannon index).
Changes from baseline to post-treatment will be calculated for each participant and summarized across the study population.
Measured: 2 weeks
Plasma concentration of indole-3-pyruvic acid (IPyA) as measured before and after berberine hydrochloride administration
Peripheral blood samples will be collected at baseline (prior to berberine hydrochloride administration) and after treatment. The concentration of indole-3-pyruvic acid (IPyA) in plasma will be quantified using a validated analytical method (liquid chromatography-mass spectrometry, LC-MS).
Changes in IPyA concentration from baseline to post-administration will be calculated for each participant and summarized across the study population.
Measured: 2 weeks
Fecal concentration of indole-3-pyruvic acid (IPyA) as measured before and after berberine hydrochloride administration
Fecal samples will be collected at baseline (prior to berberine hydrochloride administration) and after treatment. The concentration of indole-3-pyruvic acid (IPyA) in fecal samples will be quantified using a validated analytical method (liquid chromatography-mass spectrometry, LC-MS).
Changes in IPyA concentration from baseline to post-administration will be calculated for each participant and summarized across the study population.
Measured: 2 weeks
Number of participants with abnormal liver and renal function laboratory values
Blood samples will be collected at baseline (prior to berberine hydrochloride administration) and after treatment. Liver function will be assessed by serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil), and albumin. Renal function will be evaluated using serum creatinine (Cr) and blood urea nitrogen (BUN).
Abnormal laboratory values will be defined according to institutional reference ranges. The number and proportion of participants with abnormal values after treatment will be reported. Changes from baseline for each parameter will also be summarized descriptively.
Measured: 2 weeks
Proportion of VEGFA-positive cells in adenoma tissue as assessed by immunohistochemistry
Adenoma tissue samples will be obtained at the time of endoscopic resection for patients with colorectal adenomas, before and after administration of hydrochloride berberine. Immunohistochemical staining will be performed to detect vascular endothelial growth factor A (VEGFA) expression.
The proportion of VEGFA-positive cells will be quantified by calculating the percentage of positively stained cells among total cells in representative high-power fields. Results will be summarized descriptively across participants. If applicable, comparisons with baseline or between subgroups may be explored.
Measured: Baseline and at follow-up colonoscopy (approximately 6 months [±2 months] after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomasStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing-yuan Fang, MD, Ph. D
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor-investigator, Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jingyuan Fang, M.D., Principal investigator, Division of Gastroenterology and Hepatology, NHC Key Laboratory of Digestive Diseases, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519681
- Sponsor's protocol ID
- KY2025-112-B
- Status last verified
- May 2026
- First submitted
- 22 Mar 2026
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Berberine on the Human Gut Microbiome: An Exploratory Study in Healthy Volunteers and Patients With Colorectal Adenomas
- ClinicalTrials.gov ID
- NCT07519681
- Acronym / sponsor ID
- KY2025-112-B
- Conditions
- Colorectal Adenomas, Colorectal Cancers
- Keywords
- colorectal adenomas, colorectal cancers, Berberine hydrochloride, human gut microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jing-yuan Fang, MD, Ph. DUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 9 Apr 2026 (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.
Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the human gut microbiome.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Berberine hydrochloride administration | Experimental | Drug: Berberine Hydrochloride |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18-75 years;
- Had at least one but no more than six histologically confirmed colorectal adenomas (including tubular, tubulovillous, and villous adenomas) removed within 6 months prior to enrollment;
- Provide informed consent for this study and are able to comply with the requirements for collecting qualified stool specimens, peripheral blood specimens, and providing relevant lifestyle and medical history information.
- Aged 18-75 years;
- Have undergone colonoscopy within 6 months prior to enrollment with no histologically confirmed colorectal adenomas (including tubular, tubulovillous, and villous adenomas);
Key exclusion criteria (19 listed)
- Incomplete resection of adenoma during colonoscopy;
- Individuals at high risk for hereditary colorectal cancer;
- Regular use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, calcium, or vitamin D (defined as daily intake of ≥100 mg aspirin and ≥1200 mg calcium for at least 3 months);
- History of subtotal gastrectomy, total gastrectomy, or partial enterectomy;
- History of severe cardiac, hepatic, renal disease, or cancer;
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 |
|---|---|---|
| Berberine HydrochlorideOral Administration of Berberine Hydrochloride | Drug | Berberine hydrochloride administration |
Primary outcome
Relative abundance of Akkermansia in fecal samples as measured by quantitative PCR (qPCR)
Time frame: 2 weeks
Fecal samples will be collected at baseline (prior to berberine hydrochloride administration) and after treatment. The relative abundance of Akkermansia will be quantified using quantitative PCR (qPCR) targeting species-specific 16S rRNA gene sequences. Results will be expressed as the relative abundance normalized to total bacterial load (ΔCt method). Changes from baseline to post-treatment will be calculated for each participant and summarized across the study population.
5 secondary outcomes
Relative abundance and diversity of gut microbiota in fecal samples as assessed by 16S rRNA gene sequencing
Time frame: 2 weeks
Plasma concentration of indole-3-pyruvic acid (IPyA) as measured before and after berberine hydrochloride administration
Time frame: 2 weeks
Fecal concentration of indole-3-pyruvic acid (IPyA) as measured before and after berberine hydrochloride administration
Time frame: 2 weeks
Number of participants with abnormal liver and renal function laboratory values
Time frame: 2 weeks
Proportion of VEGFA-positive cells in adenoma tissue as assessed by immunohistochemistry
Time frame: Baseline and at follow-up colonoscopy (approximately 6 months [±2 months] after treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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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.
Jingyuan Fang, M.D. principal investigator
Division of Gastroenterology and Hepatology, NHC Key Laboratory of Digestive Diseases, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Questions about this trial
What is this clinical trial studying?
A study testing Berberine Hydrochloride in people with Colorectal Adenomas and Colorectal Cancers, run by Jing-yuan Fang, MD, Ph. D.
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 8 inclusion and 19 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: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ziran Kang, M.D. ((86)18826429521, renekang@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of Akkermansia in fecal samples as measured by quantitative PCR (qPCR) (time frame: 2 weeks). 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 11 May 2026.