Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
The study will last approximately 2 years, and the personal information of all patients will be kept strictly confidential.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phycocyanin Intervention | Experimental |
| |
| Maltodextrin Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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) |
| 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) |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaopeng Cai | Contact | +86 18768161626 | cxpeng@zju.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | China |
Not provided
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D010798 | Phycocyanin |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D052979 | Phycobiliproteins |
| D045524 | Phycobilisomes |
| D045342 | Light-Harvesting Protein Complexes |
| D045322 | Photosynthetic Reaction Center Complex Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Maltodextrin (Placebo) | Other | This is the placebo control group. The patients will receive the same dosage of maltodextrin for at least 4 weeks. |
|
| 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 |
| Baseline (Day 0) & through study completion, up to 24 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009097 | Multienzyme Complexes |
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |