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.
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.
Presence of severe comorbidities;
Allergy to phycocyanin;
Patients with a history of severe mental illness that may affect treatment compliance.
Parallel
phycocyanin
Dietary supplementOral 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 interventionThis is the placebo control group. The patients will receive the same dosage of maltodextrin for at least 4 weeks.
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.
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.
Change in Serum Aspartate Aminotransferase (AST) Level
Serum AST (U/L) will be evaluated to determine liver inflammation status and treatment response.
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.
Change in Serum IL-6 Concentration
Serum IL-6 (pg/mL) will be quantified by immunoassay to evaluate systemic inflammation.
Change in Serum TNF-α Concentration
Serum TNF-α (pg/mL) will be measured to assess inflammation associated with liver fibrosis.
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).
Change in Serum Creatinine Level
Serum creatinine (mg/dL) will be measured to monitor renal safety.
Change in Hemoglobin Level
Hemoglobin (g/dL) will be assessed as part of routine hematology monitoring for safety.
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