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Enrolling by invitation NCT06855355

CBM588 Reduces Colorectal Polyp Recurrence

No phase Interventional Colorectal Polyp

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clostridium butyricum MIYAIRI 588.
Who it may be relevant to
Registry conditions: Colorectal Polyp. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Dietary supplement Clostridium butyricum MIYAIRI 588
    A butyrate-producing probiotic, has demonstrated potential anti-inflammatory and anti-tumorigenic effects.

Primary outcome measures

  • Colorectal polyp recurrence rate (%) [Time frame: 1 year and 2.25 years after baseline colonoscopy]
Secondary outcome measures (3)
  • Adenomatous polyp recurrence rate (%) [Time frame: 1 year and 2.25 years after baseline colonoscopy]
  • Mean number of recurrent polyps [Time frame: 1 year and 2.25 years after baseline colonoscopy]
  • Polyp location distribution [Time frame: 1 year and 2.25 years after baseline colonoscopy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Prevention

Study locations

Taiwan · 1 center
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City

Identifiers

NCT: NCT06855355 · CBM588 and Colorectal Polyp

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗