Research on the Protective Effects of Phycocyanin Against Liver Fibrosis and Cirrhosis

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?

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 Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis; Liver Fibrosis
• Intervention / Treatment: Dietary supplement: phycocyanin; Other: Maltodextrin (Placebo)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaopeng Cai; Phone Number: +86 18768161626; Email: cxpeng@zju.edu.cn

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • The Second Affiliated Hospital of Zhejiang University
    • Contact: Xiaopeng Cai; Phone Number: +86 18768161626; Email: cxpeng@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Presence of severe comorbidities;
• Allergy to phycocyanin;
• Patients with a history of severe mental illness that may affect treatment compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phycocyanin Intervention	Dietary supplement: phycocyanin; 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).
Placebo Comparator: Maltodextrin Placebo	Other: Maltodextrin (Placebo); This is the placebo control group. The patients will receive the same dosage of maltodextrin for at least 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline (Day 0) and Post-treatment (Week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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.	Baseline (Day 0) and Week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Creatinine Level	Serum creatinine (mg/dL) will be measured to monitor renal safety.	Baseline (Day 0) & through study completion, up to 24 months
Change in Hemoglobin Level	Hemoglobin (g/dL) will be assessed as part of routine hematology monitoring for safety.	Baseline (Day 0) & through study completion, up to 24 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2025
• Primary Completion (Estimated): June 4, 2027
• Study Completion (Estimated): June 4, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Pathological Conditions, Signs and Symptoms; Liver Cirrhosis; Amino Acids, Peptides, and Proteins; Proteins; Pigments, Biological; Biological Factors; Enzymes; Enzymes and Coenzymes; Macromolecular Substances; Multiprotein Complexes; Plant Proteins; Phycobiliproteins; Phycobilisomes; Light-Harvesting Protein Complexes; Photosynthetic Reaction Center Complex Proteins; Multienzyme Complexes; maltodextrin; Phycocyanin
• Other Study ID Numbers: 2025-0673

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No