A Randomized Controlled Trial of a Targeted Dietary Intervention to Reshape Gut Microbiota and Lipid Metabolism for Enhancing Anti-Tumor Immunity and Prognosis in Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This prospective, randomized controlled trial investigates the efficacy of a targeted dietary intervention in patients with hepatocellular carcinoma (HCC). The study aims to compare a structured diet including probiotics and prebiotics against routine dietary care. The primary goal is to assess the impact on clinical outcomes (survival), gut microbiota composition, systemic lipid metabolism, and anti-tumor immune responses, to determine if this intervention can serve as an effective adjunctive therapy for HCC.
详细描述
Hepatocellular carcinoma (HCC) is associated with gut microbiota dysbiosis, which contributes to a pro-inflammatory and immunosuppressive tumor microenvironment via the "gut-liver axis." This study hypothesizes that modulating the gut microbiota through a targeted dietary intervention can rebalance systemic immunity and improve clinical outcomes. This single-center, prospective trial randomized 100 patients with HCC into two groups. The experimental group (n=50) received a structured dietary plan including high-fiber foods, probiotics (Bifidobacterium, Lactobacillus), and prebiotics. The control group (n=50) received routine dietary counseling. The study evaluates the intervention's effects on progression-free survival (PFS), overall survival (OS), gut microbiota diversity, serum lipid profiles, peripheral immune cell populations (CD8+ T cells, Tregs), and quality of life. The findings aim to provide robust clinical evidence for integrating microbiota-targeted dietary therapy into the standard management of HCC.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years.
- •Pathologically confirmed primary Hepatocellular Carcinoma (HCC).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Adequate organ function (e.g., liver, renal, and bone marrow).
- •Life expectancy of at least 3 months.
- •Willingness to provide informed consent and adhere to study procedures.
排除标准
- •Concurrent malignancies other than HCC.
- •Severe, uncontrolled comorbidities (e.g., congestive heart failure, renal failure).
- •Known history of severe intestinal diseases such as inflammatory bowel disease.
- •Use of antibiotics, probiotics, or other microbiota-altering agents within 4 weeks prior to enrollment.
- •Cognitive impairment precluding understanding of the study.
- •Refusal to provide consent.
研究组 & 干预措施
Experimental: Targeted Dietary Intervention Group
Patients received routine care plus a structured dietary intervention for the duration of follow-up. The intervention included: 1) A diet plan emphasizing high-fiber foods and lean proteins; 2) A daily multi-species probiotic supplement (≥1x10¹⁰ CFU/day); 3) Encouraged intake of prebiotics (inulin, fructooligosaccharides) and unsaturated fatty acids.
干预措施: Structured Dietary Intervention (Behavioral)
Active Comparator: Control Group
Patients received routine dietary care and counseling according to institutional guidelines for HCC patients. This included general advice on maintaining adequate caloric and protein intake.
干预措施: Routine Dietary Care (Behavioral)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Through study completion, an average of 12 months
Defined as the time from randomization to the first documented disease progression or death from any cause, whichever occurred first. Disease progression was assessed according to standard oncologic criteria.
Overall Survival (OS)
时间窗: Through study completion, an average of 12 months
Defined as the time from randomization to death from any cause.
次要结局
- Change in Gut Microbiota Alpha-Diversity(Baseline, 12 months)
- Change in Gut Microbiota Composition(Baseline, 12 months)
- Change in Serum Lipid Profile(Baseline, 12 months)
- Change in Health-Related Quality of Life (QOL)(Baseline, 12 months)
- Incidence of Treatment-Related Adverse Events(Throughout the study duration, up to 18 months)
研究者
Feifei Wang
Principal investigator
The First Hospital of Hebei Medical University