Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
NCT Number: NCT06855355
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Kaohsiung City, Taiwan, 80756
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A butyrate-producing probiotic, has demonstrated potential anti-inflammatory and anti-tumorigenic effects.
Other names: MIYARISAN BM
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.
Time frame: 1 year and 2.25 years after baseline colonoscopy
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
The average number of polyps detected per participant during follow-up colonoscopy.
Time frame: 1 year and 2.25 years after baseline colonoscopy
The proportion of recurrent polyps found in different segments of the colon (right colon, left colon, rectum).
Kaohsiung Medical University
Other
Clostridium Butyricum MIYAIRI 588 Reduces Colorectal Adenomatous Polyp Recurrence: A Randomized Crossover Trial
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