Research on the Role of Phycocyanin in the Prevention, Treatment, and Mechanism of Liver Fibrosis/Cirrhosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change in Liver Stiffness Measured by Ultrasound Elastography
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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.
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.
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
- Gene Expression Changes in Liver Tissue(At the time of liver transplantation surgery (if applicable))
- Change in Serum IL-6 Concentration(Baseline (Day 0) and Week 4)
- Change in Serum TNF-α Concentration(Baseline (Day 0) and Week 4)
- Change in Serum Metabolite Concentrations Identified by Mass Spectrometry(Baseline (Day 0) and Week 4)
- Gut Microbiome Composition and Diversity(Baseline (Day 0) and Week 4)