Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Routine Dietary Care | Behavioral | — | UNRESOLVED |
| Structured Dietary Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Targeted Dietary Intervention 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.
- interventionNames
- Behavioral: Structured Dietary Intervention
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator: Control 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.
- interventionNames
- Behavioral: Routine Dietary Care
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDShen X, Zhao D, Wang F, Li X, Sun K, Du H, Song S, Nie L, Wang C. Dietary intervention reshapes gut microbiota and lipid metabolism to enhance anti-tumor immunity and prognosis in hepatocellular carcinoma: a randomized controlled trial. BMC Cancer. 2026 Jan 6;26(1):42. doi: 10.1186/s12885-025-15325-z. PMID 41491437