NCT07519681尚未招募不适用
Effects of Berberine on the Human Gut Microbiome: An Exploratory Study in Healthy Volunteers and Patients With Colorectal Adenomas
Jing-yuan Fang, MD, Ph. D0 个研究点目标入组 20 人开始时间: 2026年5月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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;
- •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.
研究者
Jing-yuan Fang, MD, Ph. D
Professor Dr. Jing-yuan Fang
Shanghai Jiao Tong University School of Medicine
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