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NCT07519681Not yet recruiting

Effects of Berberine on the Human Gut Microbiome

Effects of Berberine on the Human Gut Microbiome: An Exploratory Study in Healthy Volunteers and Patients With Colorectal Adenomas

Source: ClinicalTrials.gov · Last updated 11 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
22 Mar 2026
Start date
15 May 2026
Primary completion date
15 Sept 2026
Lead sponsor
Jing-yuan Fang, MD, Ph. D
NCT number
NCT07519681

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 15 May 2026 to the primary completion date, 15 Sept 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Incomplete resection of adenoma during colonoscopy;
  • Use of antibiotics, probiotics, or prebiotics within 1 month prior to enrollment.
    • The following healthy subjects:
  • Use of antibiotics, probiotics, or prebiotics within 1 month prior to enrollment.

Other illness

  • Individuals at high risk for hereditary colorectal cancer;
  • History of subtotal gastrectomy, total gastrectomy, or partial enterectomy;
  • History of severe cardiac, hepatic, renal disease, or cancer;
  • Severe constipation or psychiatric disorders;
  • Individuals at high risk for hereditary colorectal cancer;
  • History of subtotal gastrectomy, total gastrectomy, or partial enterectomy;
  • History of severe cardiac, hepatic, renal disease, or cancer;
  • Severe constipation or psychiatric disorders;

Lab values

  • 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);
  • 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);

Other

  • The following outpatients undergoing colonoscopy at Renji Hospital:
  • 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).
  • 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).

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.