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NCT Number: NCT07271576

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

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Key information

Conditions

Liver Fibrosis Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhejiang University

Hangzhou, China

Location status: Recruiting

Location contact

Xiaopeng Cai

CONTACT

[email protected]

+86 18768161626

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

phycocyanin

Dietary 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Gene Expression Changes in Liver Tissue

    Time frame: At the time of liver transplantation surgery (if applicable)

    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.

  2. Change in Serum IL-6 Concentration

    Time frame: Baseline (Day 0) and Week 4

    Serum IL-6 (pg/mL) will be quantified by immunoassay to evaluate systemic inflammation.

  3. Change in Serum TNF-α Concentration

    Time frame: Baseline (Day 0) and Week 4

    Serum TNF-α (pg/mL) will be measured to assess inflammation associated with liver fibrosis.

  4. Gut Microbiome Composition and Diversity

    Time frame: Baseline (Day 0) and Week 4

    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).

  5. Change in Serum Metabolite Concentrations Identified by Mass Spectrometry

    Time frame: Baseline (Day 0) and Week 4

    Concentrations (μmol/L) of selected metabolites will be profiled via targeted or untargeted metabolomics to identify metabolic shifts associated with treatment.

Other outcomes

  1. Change in Serum Creatinine Level

    Time frame: Baseline (Day 0) & through study completion, up to 24 months

    Serum creatinine (mg/dL) will be measured to monitor renal safety.

  2. Change in Hemoglobin Level

    Time frame: Baseline (Day 0) & through study completion, up to 24 months

    Hemoglobin (g/dL) will be assessed as part of routine hematology monitoring for safety.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaopeng Cai

CONTACT

[email protected]

+86 18768161626

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Research on the Role of Phycocyanin in the Prevention, Treatment, and Mechanism of Liver Fibrosis/Cirrhosis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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