Effects of Berberine on the Human Gut Microbiome

Jing-yuan Fang, MD, Ph. D

Status: Not yet enrolling

Conditions: Colorectal Cancers; Colorectal Adenomas

Treatments: Drug: Berberine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT07519681

KY2025-112-B

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Outpatients undergoing colonoscopy at Renji Hospital who meet the following criteria:

1. Aged 18-75 years;
2. 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;
3. 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:

1. Aged 18-75 years;
2. Have undergone colonoscopy within 6 months prior to enrollment with no histologically confirmed colorectal adenomas (including tubular, tubulovillous, and villous adenomas);
3. 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.

Exclusion criteria

The following outpatients undergoing colonoscopy at Renji Hospital:

1. Incomplete resection of adenoma during colonoscopy;
2. Individuals at high risk for hereditary colorectal cancer;
3. 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);
4. History of subtotal gastrectomy, total gastrectomy, or partial enterectomy;
5. History of severe cardiac, hepatic, renal disease, or cancer;
6. Severe constipation or psychiatric disorders;
7. Pregnant, breastfeeding, or planning to become pregnant;
8. Undergone colonoscopy with inadequate bowel preparation (rated as "poor" or "insufficient" according to the Aronchik scale) or short observation time (withdrawal time <6 minutes).
9. Use of antibiotics, probiotics, or prebiotics within 1 month prior to enrollment.

The following healthy subjects:

1. Individuals at high risk for hereditary colorectal cancer;
2. 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);
3. History of subtotal gastrectomy, total gastrectomy, or partial enterectomy;
4. History of severe cardiac, hepatic, renal disease, or cancer;
5. Severe constipation or psychiatric disorders;
6. Pregnant, breastfeeding, or planning to become pregnant;
7. Undergone colonoscopy with inadequate bowel preparation (rated as "poor" or "insufficient" according to the Aronchik scale) or short observation time (withdrawal time <6 minutes).
8. Use of antibiotics, probiotics, or prebiotics within 1 month prior to enrollment.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Berberine hydrochloride administration

Experimental group

Treatment:

Drug: Berberine Hydrochloride