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| Name | Class |
|---|---|
| Shanghai Jiao Tong University School of Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berberine hydrochloride administration | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine Hydrochloride | Drug | Oral Administration of Berberine Hydrochloride |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Changes from baseline to post-treatment will be calculated for each participant and summarized across the study population. |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziran Kang, M.D. | Contact | (86)18826429521 | renekang@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jingyuan Fang, M.D. | Division of Gastroenterology and Hepatology, NHC Key Laboratory of Digestive Diseases, Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Principal Investigator |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 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. | 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. | 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. | 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. | Baseline and at follow-up colonoscopy (approximately 6 months [±2 months] after treatment) |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |