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Not yet recruiting NCT07519681

Effects of Berberine on the Human Gut Microbiome

No phase Interventional Colorectal Adenomas Colorectal Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Berberine Hydrochloride.
Who it may be relevant to
Registry conditions: Colorectal Adenomas, Colorectal Cancers. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Berberine Hydrochloride
    Oral Administration of Berberine Hydrochloride

Primary outcome measures

  • Relative abundance of Akkermansia in fecal samples as measured by quantitative PCR (qPCR) [Time frame: 2 weeks]
Secondary outcome measures (5)
  • Relative abundance and diversity of gut microbiota in fecal samples as assessed by 16S rRNA gene sequencing [Time frame: 2 weeks]
  • Plasma concentration of indole-3-pyruvic acid (IPyA) as measured before and after berberine hydrochloride administration [Time frame: 2 weeks]
  • Fecal concentration of indole-3-pyruvic acid (IPyA) as measured before and after berberine hydrochloride administration [Time frame: 2 weeks]
  • Number of participants with abnormal liver and renal function laboratory values [Time frame: 2 weeks]
  • Proportion of VEGFA-positive cells in adenoma tissue as assessed by immunohistochemistry [Time frame: Baseline and at follow-up colonoscopy (approximately 6 months [±2 months] after treatment)]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07519681 · KY2025-112-B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗