Spirulina (FEM-102) Supplement to Chronic Hepatitis B Patients

Study Overview
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Brief Summary
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Hepatocellular carcinoma (HCC), listed among lung and breast cancers as the top-ten cancer in 2016 Taiwan, is the second most prevalent cancer, just one place below colon cancer. Due to mass hepatitis B vaccination and the screening and therapeutic plan against hepatitis B and C viruses (HBV and HCV, respectively), the incidence of liver cancer drops significantly, however, still around twenty out of per hundred thousand population die from liver cancer each year. For patients suffering HBV and HCV, the prevention of HCC is a crucial health issue.

Detailed Description
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Hepatocellular carcinoma (HCC), listed among lung and breast cancers as the top-ten cancer in 2016 Taiwan, is the second most prevalent cancer, just one place below colon cancer. Due to mass hepatitis B vaccination and the screening and therapeutic plan against hepatitis B and C viruses (HBV and HCV, respectively), the incidence of liver cancer drops significantly, however, still around twenty out of per hundred thousand population die from liver cancer each year. For patients suffering HBV and HCV, the prevention of HCC is a crucial health issue. The cause of HCC is mainly related to the hepatitis of HBV or HCV infection and subsequent cirrhosis. The population of HBV carrier is over 350 million in the world, three-fourths of them live in Asia-Pacific area. Therefore, hepatitis B may be the leading cause of HCC. For Taiwanese people born before 1986, the prevalence rate of hepatitis B is extremely high as 15-20%, and around 80% of HCC patients are also HBV carriers. In the past 20 years, for patients suffering with high level of HBV during immune clearance phase, immune residual inactive phase, reactivation phase and cirrhosis, our national health insurance cover the cost of interferon or other oral anti-virus medicine with defined criteria, dramatically lowering the risk of HCC developed from hepatitis B. In previous clinical trial, some carriers showed high incidence of HCC when their quantitative hepatitis B surface antigen (qHBsAg) is high, especially when it is higher than 2000 IU/ml. The risk of HCC is still five-fold higher when the serum qHBsAg is above 1000 IU/ml. Therefore, it's important to explore novel intervention lowering qHBsAg. Spirulina, as demonstrated in previous researches in vitro and in animals, can regulate immunity, enhance anti-virus activity, lower inflammation response and slower tumor progression. Liver function and liver fibrosis is improved by Spirulina as well. In our recent clinical trial, hepatitis B patients that received anti-virus medicine orally and was supplemented with Spirulina FEM-102 showed lower qHBsAg, reflecting the clearance of cccDNA. It might be related to immune modulation against HBV, which is induced by Spirulina. Most chronic hepatitis patients do not meet most criteria of intervention according to our current guidelines. Since we already confirmed that Spirulina supplement can lower qHBsAg in treated patients, in this study we aim to understand whether Spirulina FEM-102, which regulate immunity against HBV as shown by the lowered qHBsAg, can lower the risk of HCC development of untreated patients.

Official Title
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Spirulina (FEM-102) Supplement to Chronic Hepatitis B Patients With High Levels of Quantitative Hepatitis B Surface Antigen

Conditions
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Chronic Hepatitis b

Intervention / Treatment
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* Dietary Supplement: Spirulina


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic hepatitis B do not take oral antiviral drugs. Ages between 20 and 75. High concentration of qHBsAg. qHBsAg≧1000 IU/ mL Exclusion Criteria: People allergic to seefood. Pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Baseline<br>Did not take nutritious food | Dietary Supplement: Spirulina<br>* Spirulina, as demonstrated in previous researches in vitro and in animals, can regulate immunity, enhance anti-virus activity, lower inflammation response and slower tumor progression. Liver function and liver fibrosis is improved by Spirulina as well. In our recent clinical trial, hepatitis B patients that received anti-virus medicine orally and was supplemented with Spirulina FEM-102 showed lower qHBsAg, reflecting the clearance of cccDNA. It might be related to immune modulation against HBV, which is induced by Spirulina.<br>|
| Experimental: General dose<br>Taking 6g spirulina | Dietary Supplement: Spirulina<br>* Spirulina, as demonstrated in previous researches in vitro and in animals, can regulate immunity, enhance anti-virus activity, lower inflammation response and slower tumor progression. Liver function and liver fibrosis is improved by Spirulina as well. In our recent clinical trial, hepatitis B patients that received anti-virus medicine orally and was supplemented with Spirulina FEM-102 showed lower qHBsAg, reflecting the clearance of cccDNA. It might be related to immune modulation against HBV, which is induced by Spirulina.<br>|
| Experimental: Double dose<br>Taking 12g spirulina | Dietary Supplement: Spirulina<br>* Spirulina, as demonstrated in previous researches in vitro and in animals, can regulate immunity, enhance anti-virus activity, lower inflammation response and slower tumor progression. Liver function and liver fibrosis is improved by Spirulina as well. In our recent clinical trial, hepatitis B patients that received anti-virus medicine orally and was supplemented with Spirulina FEM-102 showed lower qHBsAg, reflecting the clearance of cccDNA. It might be related to immune modulation against HBV, which is induced by Spirulina.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA | The change of HBV DNA during six months | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spirulina, Antigen