Hepatocellular Carcinoma (HCC)NCT07143955
Dietary Intervention and Gut Microbiota in Hepatocellular Carcinoma (HCC)
A study testing Structured Dietary Intervention and Routine Dietary Care in people with Hepatocellular Carcinoma (HCC), run by The First Hospital of Hebei Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Structured Dietary Intervention and Routine Dietary Care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: 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
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.
Read the 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)
- Being tested
- Structured Dietary Intervention, Routine Dietary Care
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Dietary InterventionBehavioural
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.
Routine Dietary CareBehavioural
Standard institutional dietary counseling for patients with HCC, providing general advice on nutrition.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Routine Dietary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 12 months
Overall Survival (OS)
Defined as the time from randomization to death from any cause.
Measured: Through study completion, an average of 12 months
Secondary outcomes (5)
Change in Gut Microbiota Alpha-Diversity
Measured by the Shannon and Simpson indices from fecal samples using 16S rRNA sequencing.
Measured: Baseline, 12 months
Change in Gut Microbiota Composition
Relative abundance of key bacterial genera (e.g., Bifidobacterium, Lactobacillus, Escherichia coli) assessed by 16S rRNA sequencing.
Measured: Baseline, 12 months
Change in Serum Lipid Profile
Measured levels of serum cholesterol and triglycerides.
Measured: Baseline, 12 months
Change in Health-Related Quality of Life (QOL)
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.
Measured: Baseline, 12 months
Incidence of Treatment-Related Adverse Events
Safety and tolerability assessed by documenting adverse events throughout the study.
Measured: Throughout the study duration, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 May 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feifei Wang, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143955
- Sponsor's protocol ID
- 2022S00117
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shen 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.
PubMed 41491437
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07143955
- Acronym / sponsor ID
- 2022S00117
- Conditions
- Hepatocellular Carcinoma (HCC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Targeted Dietary Intervention Group | Experimental | Behavioral: Structured Dietary InterventionPatients 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. |
| Active Comparator: Control Group | Active comparator | Behavioral: Routine Dietary CarePatients received routine dietary care and counseling according to institutional guidelines for HCC patients. This included general advice on maintaining adequate caloric and protein intake. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Dietary InterventionA 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. | Behavioural | Experimental: Targeted Dietary Intervention Group |
| Routine Dietary CareStandard institutional dietary counseling for patients with HCC, providing general advice on nutrition. | Behavioural | Active Comparator: Control Group |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 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)
Time frame: Through study completion, an average of 12 months
Defined as the time from randomization to death from any cause.
5 secondary outcomes
Change in Gut Microbiota Alpha-Diversity
Time frame: Baseline, 12 months
Change in Gut Microbiota Composition
Time frame: Baseline, 12 months
Change in Serum Lipid Profile
Time frame: Baseline, 12 months
Change in Health-Related Quality of Life (QOL)
Time frame: Baseline, 12 months
Incidence of Treatment-Related Adverse Events
Time frame: Throughout the study duration, up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Derived from this study: PubMed 41491437Shen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Dietary Intervention and Routine Dietary Care in people with Hepatocellular Carcinoma (HCC), run by The First Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Through study completion, an average of 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07143955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.