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Enrolling by Invitation

NCT Number: NCT06855355

CBM588 Reduces Colorectal Polyp Recurrence

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 80756

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clostridium butyricum MIYAIRI 588

Dietary Supplement

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

Other names: MIYARISAN BM

Primary outcomes

  1. Colorectal polyp recurrence rate (%)

    Time frame: 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 outcomes

  1. Adenomatous polyp recurrence rate (%)

    Time frame: 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.

  2. Mean number of recurrent polyps

    Time frame: 1 year and 2.25 years after baseline colonoscopy

    The average number of polyps detected per participant during follow-up colonoscopy.

  3. Polyp location distribution

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Mar 3, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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