CBM588 Reduces Colorectal Polyp Recurrence

Clostridium Butyricum MIYAIRI 588 Reduces Colorectal Adenomatous Polyp Recurrence: A Randomized Crossover Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Polyp
• Intervention / Treatment: Dietary supplement: Clostridium butyricum MIYAIRI 588

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 Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBM588 First-Year Treatment Group (Group A); .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; A butyrate-producing probiotic, has demonstrated potential anti-inflammatory and anti-tumorigenic effects.; Other Names: MIYARISAN BM
Active Comparator: CBM588 Second-Year Treatment Group (Group B); .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.; Other Names: MIYARISAN BM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year and 2.25 years after baseline colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenomatous polyp recurrence rate (%)	The percentage of participants with at least one recurrent adenomatous polyp detected during follow-up colonoscopy.	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.	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).	1 year and 2.25 years after baseline colonoscopy

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: gut microbiota; butyrate-producing bacteria; probiotic therapy; colorectal neoplasia prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Disease Attributes; Recurrence; Polyps
• Other Study ID Numbers: CBM588 and Colorectal Polyp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No