Effects of Berberine on the Human Gut Microbiome

Starting soon · Not applicable

Conditions studied: Colorectal Adenomas, Colorectal Cancers

In brief

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.

Key facts

Study ID

NCT07519681

Run by

Jing-yuan Fang, MD, Ph. D

People needed

20

Starts

2026-05-15

Expected to finish

2026-10-15

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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