NCT07143955

Dietary Intervention and Gut Microbiota in Hepatocellular Carcinoma (HCC)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: The First Hospital of Hebei Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
BEHAVIORAL	Structured Dietary Intervention	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.
BEHAVIORAL	Routine Dietary Care	Standard institutional dietary counseling for patients with HCC, providing general advice on nutrition.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2025-08-27
• Last updated: 2025-08-27

Locations

1 site across 1 country: China