Effects of Combined Dietary Fiber and Probiotic Supplementation on Gut Microbiota, Immune Function, and Clinical Outcomes in Patients With Advanced Colorectal Cancer: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Relative Abundance of Probiotics
研究概览
简要总结
This single-center, prospective, randomized controlled trial was conducted to evaluate the efficacy of a 12-week combined dietary fiber and probiotic supplementation on gut microbiota, immune function, nutritional status, and survival outcomes in malnourished patients with advanced colorectal cancer undergoing conventional therapy, compared to standard nutritional support alone.
详细描述
Patients with advanced colorectal cancer often suffer from malnutrition and immune suppression, which can negatively impact treatment outcomes. This study investigated whether modulating the gut microbiota could improve clinical outcomes. A total of 80 eligible patients were randomly assigned in a 1:1 ratio to an intervention group or a control group. The intervention group (n=40) received standard nutritional support plus a daily supplement of mixed dietary fiber and multi-strain probiotics for 12 weeks. The control group (n=40) received standard nutritional support alone. Key endpoints, including immune markers (IgA, IgG, CD4+/CD8+ ratio), gut microbiota composition (16S rRNA sequencing), nutritional status (BMI, PG-SGA), and quality of life (WHOQOL-100), were assessed at baseline and after 12 weeks. Survival was monitored for 18 months to determine the impact on short-term prognosis.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed diagnosis of stage II-IV colorectal cancer post-resection.
- •Receiving active adjuvant chemotherapy.
- •Documented moderate-to-severe malnutrition (PG-SGA score ≥ 4).
- •Ability to tolerate oral intake.
- •Voluntarily signed the informed consent form.
排除标准
- •Presence of complete bowel obstruction.
- •Severe, uncontrolled organ dysfunction (cardiac, hepatic, renal).
- •Known allergy to any component of the nutritional supplements.
- •Concurrent participation in another interventional trial.
研究组 & 干预措施
Experimental: Intervention Group
Patients were randomized to receive standard nutritional support supplemented with a daily combined formulation of dietary fiber and multi-strain probiotics for 12 weeks.
干预措施: Combined Dietary Fiber and Probiotics. (Dietary Supplement)
Active Comparator: Control Group
Patients were randomized to receive standard nutritional support alone for 12 weeks.
干预措施: Standard Nutritional Support (Other)
结局指标
主要结局
Change in Relative Abundance of Probiotics
时间窗: Baseline and 12 weeks
Quantification of the relative abundance of key probiotic genera (Bifidobacterium, Lactobacillus) in fecal samples via 16S rRNA sequencing.
Change in Immunoglobulin A (IgA) level
时间窗: Baseline and 12 weeks
Measurement of plasma IgA levels to assess humoral immune response.
Change in Immunoglobulin G (IgG) level
时间窗: Baseline and 12 weeks
Measurement of plasma IgG levels to assess humoral immune response.
Change in CD4+/CD8+ T-lymphocyte ratio
时间窗: Baseline and 12 weeks
Measurement of the ratio of CD4+ to CD8+ T-lymphocytes from peripheral blood to assess cellular immune status.
Change in Gut Microbiota Alpha Diversity
时间窗: Baseline and 12 weeks
Assessment of microbial diversity within fecal samples, measured by the Shannon index based on 16S rRNA gene sequencing.
次要结局
- Change in Body Mass Index (BMI)(Baseline and 12 weeks)
- Change in Patient-Generated Subjective Global Assessment (PG-SGA) score(Baseline and 12 weeks)
- Change in Quality of Life (WHOQOL-100) score(Baseline and 12 weeks)
- 3-Year Overall Survival Rate(Up to 3 years)
- Incidence of Major Treatment-Related Complications(During the 12-week intervention period)
研究者
Feifei Wang
Principal Investigator
The First Hospital of Hebei Medical University