CBM588 Reduces Colorectal Polyp Recurrence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-10

Study Completion Date

2028-12-31

Brief Summary

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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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Detailed Description

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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

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Colorectal Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Clostridium butyricum MIYAIRI 588

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type ACTIVE_COMPARATOR

Clostridium butyricum MIYAIRI 588

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Clostridium butyricum MIYAIRI 588

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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MIYARISAN BM

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No