Dietary Intervention and Gut Microbiota in Hepatocellular Carcinoma (HCC)

NCT ID: NCT07143955

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-09-30

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Structured Dietary Intervention

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Routine Dietary Care

Intervention Type: BEHAVIORAL

Standard institutional dietary counseling for patients with HCC, providing general advice on nutrition.

Interventions

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.

Intervention Type: BEHAVIORAL

Routine Dietary Care

Standard institutional dietary counseling for patients with HCC, providing general advice on nutrition.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Feifei Wang

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

2022S00117

Identifier Type: -

Identifier Source: org_study_id