An interventional study of Clostridium butyricum MIYAIRI 588 in Colorectal Polyp, sponsored by Kaohsiung Medical University. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Kaohsiung Medical University · Not applicable, Interventional, and Prevention
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:
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:
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.
312 studies on the registry are indexed under Polyps; 60 are open to participants now.
This study's planned enrollment of 500 is above the median of 150 across 204 interventional studies indexed under Polyps.
Browse Polyps studies →Kaohsiung Medical University is the lead sponsor of 56 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
.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.
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.
Dietary Supplement: Clostridium butyricum MIYAIRI 588
A butyrate-producing probiotic, has demonstrated potential anti-inflammatory and anti-tumorigenic effects.
Also known as: MIYARISAN BM
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.
Time frame: 1 year and 2.25 years after baseline colonoscopy
Adenomatous polyp recurrence rate (%)
The percentage of participants with at least one recurrent adenomatous polyp detected during follow-up colonoscopy.
Time frame: 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.
Time frame: 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).
Time frame: 1 year and 2.25 years after baseline colonoscopy
Plan to share: 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.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Clostridium butyricum miyairi 588 strain
Kaohsiung Medical University