Spirulina Tablets Treat Liver Fibrosis/Cirrhosis

NCT ID: NCT06770283

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-26
• Study Completion Date: 2026-12-26

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.

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

placebo

The control group will receive an equivalent dose of maltodextrin for at least 3 weeks.

Group Type: PLACEBO_COMPARATOR

Maltodextrin (Placebo)

Intervention Type: DIETARY_SUPPLEMENT

In the control group, patients will receive oral maltodextrin tablet treatment (2g/day) for at least 3 weeks before liver transplantation.

Spirulina treatment

In the Spirulina tablet intervention group, patients will receive oral Spirulina tablet treatment (2g/day) for at least 3 weeks before liver transplantation.

Group Type: ACTIVE_COMPARATOR

Spirulina tablet

Intervention Type: DIETARY_SUPPLEMENT

In the Spirulina tablet intervention group, patients will receive oral Spirulina tablet treatment (2g/day) for at least 3 weeks before liver transplantation.

Interventions

Spirulina tablet

In the Spirulina tablet intervention group, patients will receive oral Spirulina tablet treatment (2g/day) for at least 3 weeks before liver transplantation.

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin (Placebo)

In the control group, patients will receive oral maltodextrin tablet treatment (2g/day) for at least 3 weeks before liver transplantation.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Diagnosed with liver fibrosis or cirrhosis.
• Patients scheduled for liver transplantation with a waiting time of more than 3 weeks.
• Adults aged 18 to 75 years.
• Willing to participate in the study and sign an informed consent form.
• No acute diseases or significant exacerbation of symptoms in the 4 weeks prior to enrollment.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2024-1239

Identifier Type: -

Identifier Source: org_study_id