Could a common chinese medicine ingredient fight colon cancer by changing gut bugs?
NCT ID NCT07519681
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether berberine, a compound found in some Chinese herbs, can change the types of bacteria living in the gut. Researchers will give berberine to healthy volunteers and to people who have had colon polyps removed. They will measure changes in a specific bacterium called Akkermansia, which is linked to gut health and cancer risk. The goal is to understand how berberine might help prevent colorectal cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Berberine hydrochloride
- What this could lead to
- If successful, this could point toward a way to prevent colorectal cancer by changing gut bacteria.
- What could go wrong
- This is a very small, early exploratory study with only 20 participants. It looks at bacteria levels, not cancer outcomes, so it may not lead to any treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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The official record
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