Dietary Intervention and Gut Microbiota in Hepatocellular Carcinoma (HCC)

NCT07143955 | Completed

• 1 other identifier: 2022S00117
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Change in Gut Microbiota Alpha-Diversity

  Baseline, 12 months

• Change in Gut Microbiota Composition

  Baseline, 12 months

• Change in Serum Lipid Profile

  Baseline, 12 months

• Change in Health-Related Quality of Life (QOL)

  Baseline, 12 months

• Incidence of Treatment-Related Adverse Events

  Throughout the study duration, up to 18 months

Study Arms (2)

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.

Behavioral: Structured Dietary Intervention

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.

Behavioral: Routine Dietary Care

Interventions

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.

Experimental: Targeted Dietary Intervention Group

Routine Dietary Care BEHAVIORAL

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

Active Comparator: Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 27, 2025
• Study Start: May 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

CN (1)