An Observational, Real-World Study Evaluating Fecal Microbiota Transplantation for the Prevention/Reduction of Chemotherapy/Targeted Therapy-Induced Gastrointestinal Symptoms in Patients With Gastrointestinal Cancers.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence and improvement rate of chemotherapy/targeted therapy-induced gastrointestinal symptoms in patients with gastrointestinal cancers
研究概览
简要总结
The goal of this clinical trial is to learn if fecal microbiota transplantation can treat in Gastrointestinal cancer patients with chemotherapy / targeted gastrointestinal symptoms. The main question it aims to answer is: To evaluate the effect of fecal microbiota transplantation (FMT) on gastrointestinal tract in patients with gastrointestinal tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age ≥ 18 years, gender not restricted;
- •Estimated survival time ≥ 3 months;
- •Confirmed diagnosis of gastrointestinal tumors by pathological examination, including esophageal cancer, gastric cancer, colon cancer, rectal cancer, etc.;
- •TNM staging of cancer in patients is Stage IV;
- •Having undergone PD-1 or PD-L1 testing;
- •Planned to receive the 4th cycle of chemotherapy/targeted therapy;
- •Occurrence of gastrointestinal adverse reactions (including but not limited to diarrhea, constipation, vomiting, nausea, etc.) within 3 cycles of conventional chemotherapy/targeted therapy;
- •Patients are able and willing to sign the informed consent form and complete follow-up;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
- •Use of oral/intravenous broad-spectrum antibiotics with caution within 3 days;
- •Patients are able to swallow capsules without chewing;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
- •Laboratory test results during the screening period indicate that the subjects have sufficient organ function.
排除标准
- •Patients with major organ dysfunction or even failure, including but not limited to cardiac insufficiency or heart failure, renal insufficiency or renal failure, and hepatic insufficiency/hepatic failure;
- •Uncontrolled or severe infections;
- •Known history of psychotropic substance abuse, alcoholism, and drug abuse;
- •Patients with severe infections complicated with septicemia or sepsis;
- •Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules;
- •Patients with active viral infections;
- •Female subjects with a positive pregnancy test, lactating female subjects, and women of childbearing age who refuse to use contraceptive measures during the entire observation period (15 weeks);
- •Patients with gastrointestinal perforation and/or fistula;
- •Other conditions deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
Experimental Group
Patients in the FMT group received treatment starting from the fourth cycle on top of their existing regimen. They underwent one FMT treatment within 3 days prior to chemotherapy/targeted therapy during the fourth, sixth, and eighth cycles (weeks 3, 9, and 15 after study initiation). Each transplant consisted of approximately 40g of donor gut microbiota encapsulated in capsules. The capsules were administered orally, typically at a dose of 2-3 capsules (1g/capsule) every 3-5 minutes, totaling 40 capsules per dose for a total of 120 capsules. Treatment cycles were conducted every 3 weeks, with therapeutic efficacy assessed after every 2 cycles.
干预措施: Fecal microbiota transplantation (FMT) (Biological)
Control Group
Patients in the control group continued their original chemotherapy/targeted therapy regimen, with each treatment cycle lasting 3 weeks, for a total of 5 cycles. Treatment efficacy was assessed after every 2 cycles.
结局指标
主要结局
Incidence and improvement rate of chemotherapy/targeted therapy-induced gastrointestinal symptoms in patients with gastrointestinal cancers
时间窗: At 8 weeks post-FMT
This outcome measure assesses the incidence (grade ≥1 per CTCAE 5.0) and improvement rate (≥1-grade reduction in symptom severity or ≥30% decrease in EORTC QLQ-C30 scores) of chemotherapy/targeted therapy-induced gastrointestinal (GI) symptoms (e.g., nausea, vomiting, diarrhea) in patients with gastrointestinal cancers receiving fecal microbiota transplantation (FMT), as determined by scale scores and adverse event grading at baseline and post-treatment follow-up.
次要结局
- The incidence and improvement rate of gastrointestinal (GI) symptoms in patients with gastrointestinal cancers(At 4 weeks post-FMT)
- Changes in Gut Microbiota Diversity Indices(At 4, 8 weeks post-FMT)
- Correlation Between Changes in Gut Microbiota Abundance and Improvement of Gastrointestinal Symptoms(At 8 weeks post-FMT)