Liver Cirrhosis, Liver Fibrosis
Conditions
Brief 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 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.
Interventions
DIETARY_SUPPLEMENTphycocyanin
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).
OTHERMaltodextrin (Placebo)
This is the placebo control group. The patients will receive the same dosage of maltodextrin for at least 4 weeks.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Alanine Aminotransferase (ALT) Level | 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 | Baseline (Day 0) and Post-treatment (Week 4) | Serum AST (U/L) will be evaluated to determine liver inflammation status and treatment response. |
| Change in Liver Stiffness Measured by Ultrasound Elastography | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum TNF-α Concentration | Baseline (Day 0) and Week 4 | Serum TNF-α (pg/mL) will be measured to assess inflammation associated with liver fibrosis. |
| Change in Serum Metabolite Concentrations Identified by Mass Spectrometry | 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. |
| Gut Microbiome Composition and Diversity | 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). |
| Gene Expression Changes in Liver Tissue | 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. |
| Change in Serum IL-6 Concentration | Baseline (Day 0) and Week 4 | Serum IL-6 (pg/mL) will be quantified by immunoassay to evaluate systemic inflammation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Creatinine Level | Baseline (Day 0) & through study completion, up to 24 months | Serum creatinine (mg/dL) will be measured to monitor renal safety. |
| Change in Hemoglobin Level | Baseline (Day 0) & through study completion, up to 24 months | Hemoglobin (g/dL) will be assessed as part of routine hematology monitoring for safety. |
Countries
China
Contacts
Primary ContactXiaopeng Cai
Outcome results
None listed