Colorectal PolypNCT06855355
CBM588 Reduces Colorectal Polyp Recurrence
A study testing Clostridium butyricum MIYAIRI 588 in people with Colorectal Polyp, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
The goal of this randomized crossover clinical trial is to evaluate the efficacy of Clostridium butyricum MIYAIRI 588 (CBM588) in reducing colorectal adenomatous polyp recurrence in adult patients with a history of colorectal polyps. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Polyp
- What is being tested?
- Clostridium butyricum MIYAIRI 588
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Mar 2017to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with a history of colorectal adenomas that had been completely removed by endoscopic resection within the past three years, and who presented with recurrent colorectal polyps detected during surveillance colonoscopy
- Willingness to undergo follow-up colonoscopies at study intervals
- No antibiotic or probiotic use for at least three months before study entry
- Written informed consent obtained
Who cannot join
- History of colorectal cancer or other gastrointestinal malignancies
- Diagnosis of inflammatory bowel disease or familial adenomatous polyposis
- Use of antibiotics and other probiotics during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
About this study
Official title: Clostridium Butyricum MIYAIRI 588 Reduces Colorectal Adenomatous Polyp Recurrence: A Randomized Crossover Trial
The goal of this randomized crossover clinical trial is to evaluate the efficacy of Clostridium butyricum MIYAIRI 588 (CBM588) in reducing colorectal adenomatous polyp recurrence in adult patients with a history of colorectal polyps.
The main questions it aims to answer are:
- Does CBM588 reduce the recurrence of colorectal adenomatous polyps?
- Does CBM588 lead to a sustained decrease in polyp burden over time? Researchers will compare a group receiving CBM588 in the first year to a group receiving CBM588 in the second year (after a washout period) to determine whether CBM588 effectively lowers polyp recurrence rates and adenoma prevalence.
Read the detailed description
This randomized crossover clinical trial evaluates the effect of Clostridium butyricum MIYAIRI 588 (CBM588), a butyrate-producing probiotic, on colorectal adenomatous polyp recurrence. Participants who had undergone complete polypectomy were randomly assigned into two groups:
- Group A: Received CBM588 for one year, followed by a washout period and no treatment in the second year.
- Group B: Did not receive CBM588 in the first year but received it in the second year after a washout period.
Annual colonoscopy assessments were conducted to evaluate polyp count, type, and location. The primary outcome measure is adenoma recurrence. This study was conducted at a tertiary medical center and received Institutional Review Board (IRB) approval (KMUHIRB-F(I)-20170010). All participants provided informed consent.
- Conditions
- Colorectal Polyp
- Being tested
- Clostridium butyricum MIYAIRI 588
- Keywords
- gut microbiota, butyrate-producing bacteria, probiotic therapy, colorectal neoplasia prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clostridium butyricum MIYAIRI 588Dietary supplement
Also called MIYARISAN BM
A butyrate-producing probiotic, has demonstrated potential anti-inflammatory and anti-tumorigenic effects.
| Study group | Role | What they receive |
|---|---|---|
| CBM588 First-Year Treatment Group (Group A) | Experimental | .Participants receive Clostridium butyricum MIYAIRI 588 (CBM588) for one year. .Followed by a washout period and no treatment in the second year. .Annual colonoscopies are performed to assess polyp recurrence. Receives: Dietary Supplement: Clostridium butyricum MIYAIRI 588 |
| CBM588 Second-Year Treatment Group (Group B) | Active comparator | .Participants do not receive CBM588 in the first year. .Undergo a washout period and then begin CBM588 treatment in the second year. .Annual colonoscopies are performed to assess polyp recurrence. Receives: Dietary Supplement: Clostridium butyricum MIYAIRI 588 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal polyp recurrence rate (%)
The percentage of participants with at least one recurrent colorectal polyp detected during follow-up colonoscopy. Recurrence is defined as the presence of new polyps (adenomatous or non-adenomatous) identified on annual surveillance colonoscopy.
Measured: 1 year and 2.25 years after baseline colonoscopy
Secondary outcomes (3)
Adenomatous polyp recurrence rate (%)
The percentage of participants with at least one recurrent adenomatous polyp detected during follow-up colonoscopy.
Measured: 1 year and 2.25 years after baseline colonoscopy
Mean number of recurrent polyps
The average number of polyps detected per participant during follow-up colonoscopy.
Measured: 1 year and 2.25 years after baseline colonoscopy
Polyp location distribution
The proportion of recurrent polyps found in different segments of the colon (right colon, left colon, rectum).
Measured: 1 year and 2.25 years after baseline colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start10 Mar 2017
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiunn-Wei Wang, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855355
- Sponsor's protocol ID
- CBM588 and Colorectal Polyp
- Status last verified
- May 2025
- First submitted
- 11 Feb 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data (IPD) from this study. The primary reasons include privacy concerns, ethical considerations, and regulatory restrictions. The data contain sensitive health information, and sharing could compromise participant confidentiality. Additionally, there are no institutional or legal frameworks in place to support external data sharing for this study.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clostridium Butyricum MIYAIRI 588 Reduces Colorectal Adenomatous Polyp Recurrence: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT06855355
- Acronym / sponsor ID
- CBM588 and Colorectal Polyp
- Conditions
- Colorectal Polyp
- Keywords
- gut microbiota, butyrate-producing bacteria, probiotic therapy, colorectal neoplasia prevention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized crossover clinical trial is to evaluate the efficacy of Clostridium butyricum MIYAIRI 588 (CBM588) in reducing colorectal adenomatous polyp recurrence in adult patients with a history of colorectal polyps.
The main questions it aims to answer are:
- Does CBM588 reduce the recurrence of colorectal adenomatous polyps?
- Does CBM588 lead to a sustained decrease in polyp burden over time? Researchers will compare a group receiving CBM588 in the first year to a group receiving CBM588 in the second year (after a washout period) to determine whether CBM588 effectively lowers polyp recurrence rates and adenoma prevalence.
Detailed description
This randomized crossover clinical trial evaluates the effect of Clostridium butyricum MIYAIRI 588 (CBM588), a butyrate-producing probiotic, on colorectal adenomatous polyp recurrence. Participants who had undergone complete polypectomy were randomly assigned into two groups:
- Group A: Received CBM588 for one year, followed by a washout period and no treatment in the second year.
- Group B: Did not receive CBM588 in the first year but received it in the second year after a washout period.
Annual colonoscopy assessments were conducted to evaluate polyp count, type, and location. The primary outcome measure is adenoma recurrence. This study was conducted at a tertiary medical center and received Institutional Review Board (IRB) approval (KMUHIRB-F(I)-20170010). All participants provided informed consent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBM588 First-Year Treatment Group (Group A) | Experimental | Dietary Supplement: Clostridium butyricum MIYAIRI 588.Participants receive Clostridium butyricum MIYAIRI 588 (CBM588) for one year. .Followed by a washout period and no treatment in the second year. .Annual colonoscopies are performed to assess polyp recurrence. |
| CBM588 Second-Year Treatment Group (Group B) | Active comparator | Dietary Supplement: Clostridium butyricum MIYAIRI 588.Participants do not receive CBM588 in the first year. .Undergo a washout period and then begin CBM588 treatment in the second year. .Annual colonoscopies are performed to assess polyp recurrence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults with a history of colorectal adenomas that had been completely removed by endoscopic resection within the past three years, and who presented with recurrent colorectal polyps detected during surveillance colonoscopy
- Willingness to undergo follow-up colonoscopies at study intervals
- No antibiotic or probiotic use for at least three months before study entry
- Written informed consent obtained
Key exclusion criteria (3 listed)
- History of colorectal cancer or other gastrointestinal malignancies
- Diagnosis of inflammatory bowel disease or familial adenomatous polyposis
- Use of antibiotics and other probiotics during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clostridium butyricum MIYAIRI 588Also: MIYARISAN BMA butyrate-producing probiotic, has demonstrated potential anti-inflammatory and anti-tumorigenic effects. | Dietary supplement | CBM588 First-Year Treatment Group (Group A), CBM588 Second-Year Treatment Group (Group B) |
Primary outcome
Colorectal polyp recurrence rate (%)
Time frame: 1 year and 2.25 years after baseline colonoscopy
The percentage of participants with at least one recurrent colorectal polyp detected during follow-up colonoscopy. Recurrence is defined as the presence of new polyps (adenomatous or non-adenomatous) identified on annual surveillance colonoscopy.
3 secondary outcomes
Adenomatous polyp recurrence rate (%)
Time frame: 1 year and 2.25 years after baseline colonoscopy
Mean number of recurrent polyps
Time frame: 1 year and 2.25 years after baseline colonoscopy
Polyp location distribution
Time frame: 1 year and 2.25 years after baseline colonoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data (IPD) from this study. The primary reasons include privacy concerns, ethical considerations, and regulatory restrictions. The data contain sensitive health information, and sharing could compromise participant confidentiality. Additionally, there are no institutional or legal frameworks in place to support external data sharing for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clostridium butyricum MIYAIRI 588 in people with Colorectal Polyp, run by Kaohsiung Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal polyp recurrence rate (%) (time frame: 1 year and 2.25 years after baseline colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.