CBM588 Reduces Colorectal Polyp Recurrence

NCT06855355 | Enrolling By Invitation

• 1 other identifier: CBM588 and Colorectal Polyp
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Polyp

Keywords

gut microbiota; butyrate-producing bacteria; probiotic therapy; colorectal neoplasia prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adenomatous polyp recurrence rate (%)

  1 year and 2.25 years after baseline colonoscopy

• Mean number of recurrent polyps

  1 year and 2.25 years after baseline colonoscopy

• Polyp location distribution

  1 year and 2.25 years after baseline colonoscopy

Study Arms (2)

CBM588 First-Year Treatment Group (Group A)

EXPERIMENTAL

.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

CBM588 Second-Year Treatment Group (Group B)

ACTIVE COMPARATOR

.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

Interventions

Clostridium butyricum MIYAIRI 588 DIETARY_SUPPLEMENT

A butyrate-producing probiotic, has demonstrated potential anti-inflammatory and anti-tumorigenic effects.

Also known as: MIYARISAN BM

CBM588 First-Year Treatment Group (Group A); CBM588 Second-Year Treatment Group (Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 80756, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 3, 2025
• Study Start: March 10, 2017
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)