Berberine Hydrochloride
DrugOral Administration of Berberine Hydrochloride
NCT Number: NCT07519681
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Outpatients undergoing colonoscopy at Renji Hospital who meet the following criteria:
Healthy subjects who meet the following criteria:
Exclusion criteria
The following outpatients undergoing colonoscopy at Renji Hospital:
The following healthy subjects:
Oral Administration of Berberine Hydrochloride
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.
Time frame: 2 weeks
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:
Changes from baseline to post-treatment will be calculated for each participant and summarized across the study population.
Time frame: 2 weeks
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.
Time frame: 2 weeks
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.
Time frame: 2 weeks
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.
Time frame: Baseline and at follow-up colonoscopy (approximately 6 months [±2 months] after treatment)
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.
Contact information is provided by the study sponsor or research team.
Jing-yuan Fang, MD, Ph. D
Other
Effects of Berberine on the Human Gut Microbiome: An Exploratory Study in Healthy Volunteers and Patients With Colorectal Adenomas
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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