Liver FibrosisNCT07271576
Research on the Protective Effects of Phycocyanin Against Liver Fibrosis and Cirrhosis
A study testing phycocyanin in people with Liver Fibrosis and Liver Cirrhosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This clinical trial aims to determine whether phycocyanin, a natural protein derived from spirulina, can help treat liver fibrosis or cirrhosis in adult patients. The main questions it aims to answer are: Can phycocyanin reduce blood levels of liver enzymes (such as ALT and AST) that indicate liver damage? Can… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Fibrosis, Liver Cirrhosis
- What is being tested?
- phycocyanin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2025to 4 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between the ages of 18 and 75;
- Patients diagnosed with liver fibrosis or cirrhosis;
- Voluntary participation in this study and signing of an informed consent form;
- No acute diseases or significantly worsening symptoms for at least 4 weeks prior to enrollment.
Who cannot join
- Presence of severe comorbidities;
- Allergy to phycocyanin;
- Patients with a history of severe mental illness that may affect treatment compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University
Hangzhou
Xiaopeng Cai, +86 18768161626, cxpeng@zju.edu.cn
About this study
Official title: Research on the Role of Phycocyanin in the Prevention, Treatment, and Mechanism of Liver Fibrosis/Cirrhosis
This clinical trial aims to determine whether phycocyanin, a natural protein derived from spirulina, can help treat liver fibrosis or cirrhosis in adult patients. The main questions it aims to answer are:
- Can phycocyanin reduce blood levels of liver enzymes (such as ALT and AST) that indicate liver damage?
- Can phycocyanin improve liver stiffness as measured by ultrasound?
Read more
Researchers will compare the phycocyanin intervention group with a control group that receives a placebo (a similar-looking maltodextrin supplement without active ingredients) to explore if phycocyanin is more effective in treating liver fibrosis/cirrhosis.
Participants will:
- Take one sachet of either phycocyanin or placebo daily for at least 4 weeks.
- Attend regular clinic appointments (typically every 2-3 months) for routine monitoring of your liver condition, which will include blood and urine tests.
- Provide blood and stool samples once before the treatment and once after the 4-week treatment period.
- Undergo an ultrasound evaluation of liver stiffness.
The study will last approximately 2 years, and the personal information of all patients will be kept strictly confidential.
- Conditions
- Liver Fibrosis, Liver Cirrhosis
- Being tested
- phycocyanin, Maltodextrin (Placebo)
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phycocyaninDietary supplement
Oral phycocyanin formulation treatment, 1.5g/day, for at least 4 weeks (The phycocyanin was provided free of charge by Inner Mongolia Zaihui Shou Bio-engineering Co., Ltd., with company production license number SC12215062400192, executive standard GB 1886.309-2020, food-grade specifications, and batch number E4020250324. All samples used in the clinical study are from the same batch, packaged in opaque aluminum composite bags, 1.5g/bag, and stored frozen).
Maltodextrin (Placebo)Other
This is the placebo control group. The patients will receive the same dosage of maltodextrin for at least 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Phycocyanin Intervention | Experimental | Not described Receives: Dietary Supplement: phycocyanin |
| Maltodextrin Placebo | Placebo comparator | Not described Receives: Other: Maltodextrin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Liver Stiffness Measured by Ultrasound Elastography
Liver stiffness (kPa) will be quantified using ultrasound elastography to assess fibrosis severity and treatment-related changes.
Measured: Baseline (Day 0) and Post-treatment (Week 4)
Change in Serum Alanine Aminotransferase (ALT) Level
Serum ALT (U/L) will be measured using standard clinical chemistry methods to assess improvement in liver injury following phycocyanin treatment.
Measured: Baseline (Day 0) and Post-treatment (Week 4)
Change in Serum Aspartate Aminotransferase (AST) Level
Serum AST (U/L) will be evaluated to determine liver inflammation status and treatment response.
Measured: Baseline (Day 0) and Post-treatment (Week 4)
Secondary outcomes (5)
Gene Expression Changes in Liver Tissue
Liver tissue (~1 cm³) obtained during transplantation (if applicable) will be immediately frozen (-80°C) and analyzed by single-cell or bulk RNA sequencing to explore mechanistic effects of phycocyanin.
Measured: At the time of liver transplantation surgery (if applicable)
Change in Serum IL-6 Concentration
Serum IL-6 (pg/mL) will be quantified by immunoassay to evaluate systemic inflammation.
Measured: Baseline (Day 0) and Week 4
Change in Serum TNF-α Concentration
Serum TNF-α (pg/mL) will be measured to assess inflammation associated with liver fibrosis.
Measured: Baseline (Day 0) and Week 4
Gut Microbiome Composition and Diversity
Fecal samples will undergo metagenomic sequencing to evaluate gut microbiome changes, including overall diversity (Shannon Index) and relative abundance (%) of selected microbial taxa (e.g., Bacteroides, Firmicutes).
Measured: Baseline (Day 0) and Week 4
Change in Serum Metabolite Concentrations Identified by Mass Spectrometry
Concentrations (μmol/L) of selected metabolites will be profiled via targeted or untargeted metabolomics to identify metabolic shifts associated with treatment.
Measured: Baseline (Day 0) and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start4 Jun 2025
- Primary completion4 Jun 2027 (estimated)
- Study completion4 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Care provider
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271576
- Sponsor's protocol ID
- 2025-0673
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Role of Phycocyanin in the Prevention, Treatment, and Mechanism of Liver Fibrosis/Cirrhosis
- ClinicalTrials.gov ID
- NCT07271576
- Acronym / sponsor ID
- 2025-0673
- Conditions
- Liver Fibrosis, Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 4 Jun 2027 (estimated)
- Study completion
- 4 Jun 2027 (estimated)
- First posted
- 9 Dec 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 clinical trial aims to determine whether phycocyanin, a natural protein derived from spirulina, can help treat liver fibrosis or cirrhosis in adult patients. The main questions it aims to answer are:
- Can phycocyanin reduce blood levels of liver enzymes (such as ALT and AST) that indicate liver damage?
- Can phycocyanin improve liver stiffness as measured by ultrasound?
Researchers will compare the phycocyanin intervention group with a control group that receives a placebo (a similar-looking maltodextrin supplement without active ingredients) to explore if phycocyanin is more effective in treating liver fibrosis/cirrhosis.
Participants will:
- Take one sachet of either phycocyanin or placebo daily for at least 4 weeks.
- Attend regular clinic appointments (typically every 2-3 months) for routine monitoring of your liver condition, which will include blood and urine tests.
- Provide blood and stool samples once before the treatment and once after the 4-week treatment period.
- Undergo an ultrasound evaluation of liver stiffness.
The study will last approximately 2 years, and the personal information of all patients will be kept strictly confidential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phycocyanin Intervention | Experimental | Dietary Supplement: phycocyanin |
| Maltodextrin Placebo | Placebo comparator | Other: Maltodextrin (Placebo) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults between the ages of 18 and 75;
- Patients diagnosed with liver fibrosis or cirrhosis;
- Voluntary participation in this study and signing of an informed consent form;
- No acute diseases or significantly worsening symptoms for at least 4 weeks prior to enrollment.
Key exclusion criteria (3 listed)
- Presence of severe comorbidities;
- Allergy to phycocyanin;
- Patients with a history of severe mental illness that may affect treatment compliance.
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 |
|---|---|---|
| phycocyaninOral phycocyanin formulation treatment, 1.5g/day, for at least 4 weeks (The phycocyanin was provided free of charge by Inner Mongolia Zaihui Shou Bio-engineering Co., Ltd., with company production license number SC12215062400192, executive standard GB 1886.309-2020, food-grade specifications, and batch number E4020250324. All samples used in the clinical study are from the same batch, packaged in opaque aluminum composite bags, 1.5g/bag, and stored frozen). | Dietary supplement | Phycocyanin Intervention |
| Maltodextrin (Placebo)This is the placebo control group. The patients will receive the same dosage of maltodextrin for at least 4 weeks. | Other | Maltodextrin Placebo |
Primary outcome
Change in Liver Stiffness Measured by Ultrasound Elastography
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Liver stiffness (kPa) will be quantified using ultrasound elastography to assess fibrosis severity and treatment-related changes.
Change in Serum Alanine Aminotransferase (ALT) Level
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Serum ALT (U/L) will be measured using standard clinical chemistry methods to assess improvement in liver injury following phycocyanin treatment.
Change in Serum Aspartate Aminotransferase (AST) Level
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Serum AST (U/L) will be evaluated to determine liver inflammation status and treatment response.
5 secondary outcomes
Gene Expression Changes in Liver Tissue
Time frame: At the time of liver transplantation surgery (if applicable)
Change in Serum IL-6 Concentration
Time frame: Baseline (Day 0) and Week 4
Change in Serum TNF-α Concentration
Time frame: Baseline (Day 0) and Week 4
Gut Microbiome Composition and Diversity
Time frame: Baseline (Day 0) and Week 4
Change in Serum Metabolite Concentrations Identified by Mass Spectrometry
Time frame: Baseline (Day 0) and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phycocyanin in people with Liver Fibrosis and Liver Cirrhosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Dec 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaopeng Cai (+86 18768161626, cxpeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Liver Stiffness Measured by Ultrasound Elastography (time frame: Baseline (Day 0) and Post-treatment (Week 4)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2025.