Effects of Berberine on the Human Gut Microbiome

NCT07519681 | Not Yet Recruiting

• 1 other identifier: KY2025-112-B
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colorectal Adenomas; Colorectal Cancers

Keywords

colorectal adenomas; colorectal cancers; Berberine hydrochloride; human gut microbiome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Relative abundance and diversity of gut microbiota in fecal samples as assessed by 16S rRNA gene sequencing

  2 weeks

• Plasma concentration of indole-3-pyruvic acid (IPyA) as measured before and after berberine hydrochloride administration

  2 weeks

• Fecal concentration of indole-3-pyruvic acid (IPyA) as measured before and after berberine hydrochloride administration

  2 weeks

• Number of participants with abnormal liver and renal function laboratory values

  2 weeks

• Proportion of VEGFA-positive cells in adenoma tissue as assessed by immunohistochemistry

  Baseline and at follow-up colonoscopy (approximately 6 months [±2 months] after treatment)

Study Arms (1)

Berberine hydrochloride administration

EXPERIMENTAL

Drug: Berberine Hydrochloride

Interventions

Berberine Hydrochloride DRUG

Oral Administration of Berberine Hydrochloride

Berberine hydrochloride administration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Jing-yuan Fang, MD, Ph. D: lead
• Shanghai Jiao Tong University School of Medicine: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• 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

Central Study Contacts

Ziran Kang, M.D.

CONTACT

(86)18826429521; renekang@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Dr. Jing-yuan Fang

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: April 9, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05