Liver CirrhosisNCT06770283
Spirulina Tablets Treat Liver Fibrosis/Cirrhosis
A study testing Spirulina tablet in people with Liver Cirrhosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Spirulina tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2024to 26 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with severe comorbidities.
- Patients allergic to Spirulina tablets.
- Patients with a history of severe mental illness that could affect treatment adherence.
Trial locations and contacts
1 site in 1 country.
China1 site
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang
About this study
Official title: Research on the Prevention and Treatment of Liver Fibrosis/Cirrhosis with Spirulina Tablets and Its Mechanisms
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.
Read more
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
- Being tested
- Spirulina tablet, Maltodextrin (Placebo)
- Keywords
- Liver cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirulina tabletDietary supplement
In the Spirulina tablet intervention group, patients will receive oral Spirulina tablet treatment (2g/day) for at least 3 weeks before liver transplantation.
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.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | The control group will receive an equivalent dose of maltodextrin for at least 3 weeks. Receives: 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. Receives: Dietary Supplement: Spirulina tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Evaluation of intestinal flora
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start26 Dec 2024
- Primary completion26 Dec 2026 (estimated)
- Study completion26 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770283
- Sponsor's protocol ID
- 2024-1239
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Prevention and Treatment of Liver Fibrosis/Cirrhosis with Spirulina Tablets and Its Mechanisms
- ClinicalTrials.gov ID
- NCT06770283
- Acronym / sponsor ID
- 2024-1239
- Conditions
- Liver Cirrhosis
- Keywords
- Liver cirrhosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 26 Dec 2026 (estimated)
- Study completion
- 26 Dec 2026 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: Maltodextrin (Placebo)The control group will receive an equivalent dose of maltodextrin for at least 3 weeks. |
| Spirulina treatment | Active comparator | Dietary Supplement: Spirulina tabletIn the Spirulina tablet intervention group, patients will receive oral Spirulina tablet treatment (2g/day) for at least 3 weeks before liver transplantation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with severe comorbidities.
- Patients allergic to Spirulina tablets.
- Patients with a history of severe mental illness that could affect treatment adherence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirulina tabletIn 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 treatment |
| Maltodextrin (Placebo)In the control group, patients will receive oral maltodextrin tablet treatment (2g/day) for at least 3 weeks before liver transplantation. | Dietary supplement | placebo |
Primary outcome
single-cell and/or transcriptome sequencing
Time frame: 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.
1 secondary outcome
Evaluation of intestinal flora
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirulina tablet in people with Liver Cirrhosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
single-cell and/or transcriptome sequencing (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.