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

Официальное название

Research on the Role of Phycocyanin in the Prevention, Treatment, and Mechanism of Liver Fibrosis/Cirrhosis

Обзор

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.

Вмешательства

• Пищевая добавка phycocyanin
  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).
• Другое Maltodextrin (Placebo)
  This is the placebo control group. The patients will receive the same dosage of maltodextrin for at least 4 weeks.

Первичные конечные точки

• Change in Liver Stiffness Measured by Ultrasound Elastography [Срок оценки: Baseline (Day 0) and Post-treatment (Week 4)]
• Change in Serum Alanine Aminotransferase (ALT) Level [Срок оценки: Baseline (Day 0) and Post-treatment (Week 4)]
• Change in Serum Aspartate Aminotransferase (AST) Level [Срок оценки: Baseline (Day 0) and Post-treatment (Week 4)]

Вторичные конечные точки (5)

• Gene Expression Changes in Liver Tissue [Срок оценки: At the time of liver transplantation surgery (if applicable)]
• Change in Serum IL-6 Concentration [Срок оценки: Baseline (Day 0) and Week 4]
• Change in Serum TNF-α Concentration [Срок оценки: Baseline (Day 0) and Week 4]
• Gut Microbiome Composition and Diversity [Срок оценки: Baseline (Day 0) and Week 4]
• Change in Serum Metabolite Concentrations Identified by Mass Spectrometry [Срок оценки: Baseline (Day 0) and Week 4]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT07271576 · 2025-0673

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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