NCT06855355

CBM588 Reduces Colorectal Polyp Recurrence

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Kaohsiung Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Polyp

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Clostridium butyricum MIYAIRI 588	A butyrate-producing probiotic, has demonstrated potential anti-inflammatory and anti-tumorigenic effects.

Timeline

• Start date: 2017-03-10
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-03-03
• Last updated: 2025-05-16

Locations

1 site across 1 country: Taiwan