Dietary Intervention and Gut Microbiota in Hepatocellular Carcinoma (HCC)

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma (HCC)

• Registration Number: NCT07143955
• Lead Sponsor: The First Hospital of Hebei Medical University

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.

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2025-08
• Study First Submitted: 2025-08-13
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Through study completion, an average of 12 months	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.
Overall Survival (OS)	Through study completion, an average of 12 months	Defined as the time from randomization to death from any cause.

Secondary Outcome Measures

Name	Time	Method
Change in Gut Microbiota Alpha-Diversity	Baseline, 12 months	Measured by the Shannon and Simpson indices from fecal samples using 16S rRNA sequencing.
Change in Gut Microbiota Composition	Baseline, 12 months	Relative abundance of key bacterial genera (e.g., Bifidobacterium, Lactobacillus, Escherichia coli) assessed by 16S rRNA sequencing.
Change in Serum Lipid Profile	Baseline, 12 months	Measured levels of serum cholesterol and triglycerides.
Change in Health-Related Quality of Life (QOL)	Baseline, 12 months	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.
Incidence of Treatment-Related Adverse Events	Throughout the study duration, up to 18 months	Safety and tolerability assessed by documenting adverse events throughout the study.

Trial Locations

Locations (1)

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China