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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
Oral Administration of Berberine Hydrochloride
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.
Time frame: 2 weeks
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: 1. relative abundance of bacterial taxa at the phylum and genus levels (excluding Akkermansia where applicable), and 2. alpha diversity indices (Shannon index). Changes from baseline to post-treatment will be calculated for each participant and summarized across the study population.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: Baseline and at follow-up colonoscopy (approximately 6 months [±2 months] after treatment)