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

January 20, 2021 updated by: Taipei Medical University WanFang Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Wenshan District
      • Taipei, Wenshan District, Taiwan, 116
        • Wanfang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with chronic hepatitis B do not take oral antiviral drugs.
  2. Ages between 20 and 75.
  3. High concentration of qHBsAg. qHBsAg≧1000 IU/ mL

Exclusion Criteria:

  1. People allergic to seefood.
  2. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Baseline
Did not take nutritious food
Dietary supplement: Spirulina
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.
Experimental: General dose
Taking 6g spirulina
Dietary supplement: Spirulina
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.
Experimental: Double dose
Taking 12g spirulina
Dietary supplement: Spirulina
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Collaborators

Far East Bio-Tec Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2019

Primary Completion (Actual)

August 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 20, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201810002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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