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

NCT07271576 | Recruiting

• 1 other identifier: 2025-0673
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Fibrosis; Liver Cirrhosis

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (5)

• 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

• Gut Microbiome Composition and Diversity

  Baseline (Day 0) and Week 4

• Change in Serum Metabolite Concentrations Identified by Mass Spectrometry

  Baseline (Day 0) and Week 4

Other Outcomes (2)

• Change in Serum Creatinine Level

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

• Change in Hemoglobin Level

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

Study Arms (2)

Phycocyanin Intervention

EXPERIMENTAL

Dietary Supplement: phycocyanin

Maltodextrin Placebo

PLACEBO COMPARATOR

Other: Maltodextrin (Placebo)

Interventions

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).

Phycocyanin Intervention

Maltodextrin (Placebo) OTHER

This is the placebo control group. The patients will receive the same dosage of maltodextrin for at least 4 weeks.

Maltodextrin Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of severe comorbidities;
• Allergy to phycocyanin;
• Patients with a history of severe mental illness that may affect treatment compliance.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Phycocyanin; maltodextrin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phycobiliproteins; Phycobilisomes; Light-Harvesting Protein Complexes; Photosynthetic Reaction Center Complex Proteins; Multienzyme Complexes; Multiprotein Complexes; Macromolecular Substances; Enzymes; Enzymes and Coenzymes; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Pigments, Biological; Biological Factors

Central Study Contacts

Xiaopeng Cai

CONTACT

+86 18768161626; cxpeng@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 9, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): June 4, 2027
• Study Completion (Estimated): June 4, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-10

Locations

CN (1)