Supplementation With Clostridium Butyricum CBM588 in Patients Undergoing Pancreaticoduodenectomy for Periampullary Neoplasms: A Prospective Randomized Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Postoperative diarrhea - mean daily stool frequency
研究概览
简要总结
This is a prospective, randomized, double-blind, single-center clinical trial designed to evaluate the effects of Clostridium butyricum CBM588 supplementation on postoperative diarrhea, gastrointestinal symptoms, and quality of life in patients undergoing pancreaticoduodenectomy for periampullary neoplasms. Oncological outcomes, including disease-free survival and overall survival, will be monitored as secondary endpoints during follow-up.
详细描述
Pancreaticoduodenectomy is associated with significant postoperative gastrointestinal complications, particularly chronic diarrhea, which negatively impacts nutritional status, quality of life, and the ability to complete adjuvant oncologic treatments. Increasing evidence suggests that alterations in the gut microbiota and reduced production of short-chain fatty acids, especially butyrate, play a key role in postoperative gastrointestinal dysfunction.
Clostridium butyricum CBM588 is a butyrate-producing probiotic with a well-established safety profile and demonstrated efficacy in the management of gastrointestinal disorders. This study aims to assess whether supplementation with Clostridium butyricum CBM588 can reduce postoperative diarrhea-hypothesized as a 40-60% relative reduction compared with placebo-and improve gastrointestinal symptoms and quality of life in patients undergoing pancreaticoduodenectomy.
In addition to gastrointestinal and quality-of-life outcomes, patients will be followed longitudinally for oncological outcomes, including disease-free survival and overall survival, in order to explore potential associations between postoperative gastrointestinal recovery, nutritional status, and long-term clinical outcomes.
A total of 158 patients will be randomized in a 1:1 ratio to receive either Clostridium butyricum CBM588 or placebo for 3 months following hospital discharge. All participants in both study arms will receive standard postoperative care, including individualized nutritional counseling based on a comprehensive assessment of nutritional status and body composition (including bioimpedance analysis) according to a standardized nutritional scheme, as well as pancreatic enzyme replacement therapy prescribed as pancrelipase 50,000 IU with each main meal and 25,000 IU with each snack, in addition to other medical or pharmacological treatments as clinically indicated.
Patients will be followed for gastrointestinal outcomes and quality of life during the intervention period and for disease-free survival and overall survival during long-term follow-up. All participants will be provided with a patient diary to record date and time of study product administration, number of tablets taken, daily bowel movements, and stool consistency according to the Bristol Stool Form Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Statistical Analysts
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
- •Age ≥ 18 years
- •Written informed consent
- •Patients undergoing pancreaticoduodenectomy
- •Candidates for upfront surgery without previous neoadjuvant chemotherapy or radiotherapy
- •Patients with benign or malignant periampullary neoplasms
排除标准
- •Age < 18 years
- •Previous or current use of Clostridium butyricum CBM588
- •Lactose intolerance
- •Neoadjuvant chemotherapy or radiotherapy
研究组 & 干预措施
Clostridium butyricum CBM588
Participants randomized to the experimental arm will receive Clostridium butyricum CBM588 (Butirrisan®) supplementation in addition to standard postoperative care following pancreaticoduodenectomy.
干预措施: Clostridium butyricum CBM588 Strain (Other)
Placebo
Participants randomized to the placebo arm will receive placebo tablets identical in appearance, packaging, and dosing schedule to the experimental product, in addition to standard postoperative care following pancreaticoduodenectomy.
干预措施: Placebo (Other)
结局指标
主要结局
Postoperative diarrhea - mean daily stool frequency
时间窗: Baseline (preoperative), 1-month post-discharge, 3 months post-discharge
Mean number of bowel movements per day (Unit of Measure: bowel movements/day \[count\]), recorded using a patient-reported daily stool diary completed after hospital discharge. The primary comparison is between patients receiving Clostridium butyricum CBM588 and placebo.
次要结局
- Stool consistency - Bristol Stool Form Scale (BSFS)(Baseline (preoperative), 1-month post-discharge, and 3 months post-discharge)
- Health-related quality of life. European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Baseline (preoperative), 1-month post-discharge, and 3 months post-discharge.)
- Pancreatic cancer-specific quality of life - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module 26 (EORTC QLQ-PAN26)(Baseline (preoperative), 1-month post-discharge, and 3 months post-discharge.)
- Disease-free survival (DFS)(12 months and 24 months post-discharge)
- Overall survival (OS)(12 months and 24 months post-discharge)