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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Targeted Dietary Intervention Group | Experimental | 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. |
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| Active Comparator: Control Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Dietary Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 12 months |
| Overall Survival (OS) | Defined as the time from randomization to death from any cause. | Through study completion, an average of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gut Microbiota Alpha-Diversity | Measured by the Shannon and Simpson indices from fecal samples using 16S rRNA sequencing. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41491437 | Derived | Shen X, Zhao D, Wang F, Li X, Sun K, Du H, Song S, Nie L, Wang C. Dietary intervention reshapes gut microbiota and lipid metabolism to enhance anti-tumor immunity and prognosis in hepatocellular carcinoma: a randomized controlled trial. BMC Cancer. 2026 Jan 6;26(1):42. doi: 10.1186/s12885-025-15325-z. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Routine Dietary Care | Behavioral | Standard institutional dietary counseling for patients with HCC, providing general advice on nutrition. |
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| Baseline, 12 months |
| Change in Serum Lipid Profile | Measured levels of serum cholesterol and triglycerides. | 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. | Baseline, 12 months |
| Incidence of Treatment-Related Adverse Events | Safety and tolerability assessed by documenting adverse events throughout the study. | Throughout the study duration, up to 18 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |