Dietary Intervention and Gut Microbiota in Hepatocellular Carcinoma (HCC)

Hebei Medical University

Status: Completed

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Behavioral: Structured Dietary Intervention; Behavioral: Routine Dietary Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07143955

2022S00117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 80 years.
• Pathologically confirmed primary Hepatocellular Carcinoma (HCC).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Experimental: Targeted Dietary Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Structured Dietary Intervention

Active Comparator: Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Routine Dietary Care