CBM588 Reduces Colorectal Polyp Recurrence

Not Applicable

• Conditions: Colorectal Polyp

• Registration Number: NCT06855355
• Lead Sponsor: Kaohsiung Medical University

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.

Study Timeline

• Study Start: 2017-03-10
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-25
• Study First Posted: 2025-03-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Colorectal polyp recurrence rate (%)	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.

Secondary Outcome Measures

Name	Time	Method
Adenomatous polyp recurrence rate (%)	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.
Mean number of recurrent polyps	1 year and 2.25 years after baseline colonoscopy	The average number of polyps detected per participant during follow-up colonoscopy.
Polyp location distribution	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).

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung City, Taiwan