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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
A comprehensive dietary program consisting of dietary modification (high-fiber, lean protein), daily probiotic supplementation capsule (Bifidobacterium longum, Lactobacillus acidophilus, and Lactobacillus rhamnosus), and encouraged intake of prebiotics and unsaturated fatty acids.
Standard institutional dietary counseling for patients with HCC, providing general advice on nutrition.
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Progression-Free Survival (PFS)
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.
Time frame: Through study completion, an average of 12 months
Overall Survival (OS)
Defined as the time from randomization to death from any cause.
Time frame: Through study completion, an average of 12 months
Change in Gut Microbiota Alpha-Diversity
Measured by the Shannon and Simpson indices from fecal samples using 16S rRNA sequencing.
Time frame: Baseline, 12 months
Change in Gut Microbiota Composition
Relative abundance of key bacterial genera (e.g., Bifidobacterium, Lactobacillus, Escherichia coli) assessed by 16S rRNA sequencing.
Time frame: Baseline, 12 months
Change in Serum Lipid Profile
Measured levels of serum cholesterol and triglycerides.
Time frame: Baseline, 12 months
Change in Health-Related Quality of Life (QOL)
Assessed using the World Health Organization Quality of Life (WHOQOL-100) questionnaire. Scores for each domain range from 4 to 20, with higher scores indicating a better quality of life.
Time frame: Baseline, 12 months
Incidence of Treatment-Related Adverse Events
Safety and tolerability assessed by documenting adverse events throughout the study.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Throughout the study duration, up to 18 months