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Could a common chinese medicine ingredient fight colon cancer by changing gut bugs?

NCT ID NCT07519681

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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How to take part

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  1. The official record

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