Spirulina (FEM-102) Supplement to Chronic Hepatitis B Patients
Condition: Chronic Hepatitis b
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Spirulina
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Spirulina; Antigen