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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
500
A butyrate-producing probiotic, has demonstrated potential anti-inflammatory and anti-tumorigenic effects.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, Taiwan
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
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