Clostridium Butyricum MIYAIRI 588 Reduces Colorectal Adenomatous Polyp Recurrence: A Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Colorectal polyp recurrence rate (%)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Clostridium butyricum MIYAIRI 588 (Dietary Supplement)
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.
干预措施: Clostridium butyricum MIYAIRI 588 (Dietary Supplement)
结局指标
主要结局
Colorectal polyp recurrence rate (%)
时间窗: 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.
次要结局
- Adenomatous polyp recurrence rate (%)(1 year and 2.25 years after baseline colonoscopy)
- Mean number of recurrent polyps(1 year and 2.25 years after baseline colonoscopy)
- Polyp location distribution(1 year and 2.25 years after baseline colonoscopy)
研究者
Jiunn-Wei Wang
Doctor
Kaohsiung Medical University