Clinical trial NCT06855355: CBM588 Reduces Colorectal Polyp Recurrence
Official title: Clostridium Butyricum MIYAIRI 588 Reduces Colorectal Adenomatous Polyp Recurrence: A Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Colorectal Polyp
Keywords: gut microbiota
butyrate-producing bacteria
probiotic therapy
colorectal neoplasia prevention
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Colorectal polyp recurrence rate (%)
timeFrame: 1 year and 2.25 years after baseline colonoscopy
Secondary outcomes:
measure: Adenomatous polyp recurrence rate (%)
timeFrame: 1 year and 2.25 years after baseline colonoscopy
measure: Mean number of recurrent polyps
timeFrame: 1 year and 2.25 years after baseline colonoscopy
measure: Polyp location distribution
timeFrame: 1 year and 2.25 years after baseline colonoscopy
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
References: