Clinical trial · Interventional
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
NCT07519681CI-TRIAL-00111128not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenomas | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Colorectal Cancers | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Berberine Hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Berberine hydrochloride administration
- interventionNames
- Drug: Berberine Hydrochloride
Primary outcomes (1)
- measure
- Relative abundance of Akkermansia in fecal samples as measured by quantitative PCR (qPCR)
- timeFrame
- 2 weeks
- description
- 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.
Secondary outcomes (5)
- measure
- Relative abundance and diversity of gut microbiota in fecal samples as assessed by 16S rRNA gene sequencing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.