Spirulina Tablets Treat Liver Fibrosis/Cirrhosis

NCT06770283 | Active Not Recruiting

• 1 other identifier: 2024-1239
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• single-cell and/or transcriptome sequencing

  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.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Evaluation of intestinal flora

  through study completion, an average of 1 year

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Maltodextrin (Placebo)

Spirulina treatment

ACTIVE COMPARATOR

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

Dietary Supplement: Spirulina tablet

Interventions

Spirulina tablet 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.

Spirulina treatment

Maltodextrin (Placebo) DIETARY_SUPPLEMENT

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

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

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

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 13, 2025
• Study Start: December 26, 2024
• Primary Completion (Estimated): December 26, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: January 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)