Not Yet RecruitingNot Applicable

Effects of Berberine on the Human Gut Microbiome

20 participantsStarted 2026-05-15

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.
✓. 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

✕. 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).

What they're measuring

Relative abundance of Akkermansia in fecal samples as measured by quantitative PCR (qPCR)

Timeframe: 2 weeks

Trial details

NCT IDNCT07519681

SponsorJing-yuan Fang, MD, Ph. D

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-15

Contact for this trial

Ziran Kang, M.D.

(86)18826429521 renekang@foxmail.com

View on ClinicalTrials.gov More Colorectal Adenomas trials