CBM588 Reduces Colorectal Polyp Recurrence

Kaohsiung Medical University

Status: Invitation-only

Conditions: Colorectal Polyp

Treatments: Dietary Supplement: Clostridium butyricum MIYAIRI 588

Study type: Interventional

Funder types: Other

Identifiers

NCT06855355

CBM588 and Colorectal Polyp

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

CBM588 First-Year Treatment Group (Group A)

Experimental group

Description:

.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.

Treatment:

Dietary Supplement: Clostridium butyricum MIYAIRI 588

CBM588 Second-Year Treatment Group (Group B)

Active Comparator group

Description:

.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.

Treatment:

Dietary Supplement: Clostridium butyricum MIYAIRI 588