Spirulina Tablets Treat Liver Fibrosis/Cirrhosis

Not Applicable

Active, not recruiting

• Conditions: Liver Cirrhosis

• Registration Number: NCT06770283
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Spirulina (Spirulina platensis, SP) is a nutrient-rich blue-green algae that has been widely studied and applied in various health fields. Its main components include spirulina polysaccharide proteins, amino acids, vitamins, and minerals, especially the eight essential amino acids that the human body cannot synthesize on its own. Spirulina is also rich in minerals such as iron, calcium, and zinc, which makes it beneficial in the prevention and treatment of several diseases. Research has shown that spirulina has potential therapeutic effects in combating tumors, obesity, diabetes, cardiovascular diseases, and anemia. In 2020, the National Health Commission of the People's Republic of China classified it as a health food supplement.

Hepatic fibrosis (HF) is a process of chronic liver disease caused by excessive repair responses to liver tissue injury due to various factors. As the fibrosis progresses, extracellular matrix in the liver accumulates, forming scar tissue that gradually replaces the normal liver parenchyma. Eventually, these pathological changes can lead to cirrhosis, portal hypertension, and even primary hepatocellular carcinoma (HCC), which may result in liver failure. Therefore, hepatic fibrosis is considered a critical precursor to cirrhosis and liver cancer.

In 2007, Elsharkawy and colleagues proposed the "hepatitis-fibrosis-liver cancer axis" theory, which emphasized that timely treatment of hepatic fibrosis is crucial to controlling the development of cirrhosis and liver cancer. However, modern medicine has yet to discover specific drugs for treating hepatic fibrosis or cirrhosis. The etiology of hepatic fibrosis is complex, involving various cellular and molecular mechanisms, thus making the in-depth study of its pathogenesis and the development of new treatments particularly urgent.

As the understanding of hepatic fibrosis continues to deepen, increasing attention is being given to the potential of natural products or health supplements in preventing and treating hepatic fibrosis. Spirulina, as a natural product with multiple biological activities, may become a promising direction for exploring new treatments for hepatic fibrosis due to its immune-regulating, antioxidant, and anti-inflammatory effects. Through further clinical and experimental research, spirulina may offer a new complementary treatment option for hepatic fibrosis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-26
• Study First Submitted: 2024-12-29
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Primary Completion: 2026-12-26
• Study Completion: 2026-12-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients with severe comorbidities.
• Patients allergic to Spirulina tablets.
• Patients with a history of severe mental illness that could affect treatment adherence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
single-cell and/or transcriptome sequencing	through study completion, an average of 1 year	Prospective collection of patient fecal samples will be performed with the following sampling frequency: one sample will be collected on Day 0 before treatment, and another sample will be collected after the treatment is completed. These samples will undergo metagenomic sequencing of the gut microbiome. Prospective collection of liver tissue samples from liver transplant surgeries of patients with liver fibrosis/cirrhosis will be done, with each sample approximately 1 cm³ in size. The samples will be immediately stored at -80°C for single-cell and/or transcriptome sequencing.

Secondary Outcome Measures

Name	Time	Method
Evaluation of intestinal flora	through study completion, an average of 1 year	Prospective collection of patient fecal samples will be performed with the following sampling frequency: one sample will be collected on Day 0 before treatment, and another sample will be collected after the treatment is completed. These samples will undergo metagenomic sequencing of the gut microbiome.; High-throughput sequencing is used to sequence the 16S rDNA of prokaryotes, with the aim of detecting the microbial composition and abundance in the samples.

Trial Locations

Locations (1)

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China